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Maintain the Enameled Wire (EV) Lab, its equipment, and documentation.
Key Responsibilities Sample Preparation & Testing: Prepare copper enameled wire samples for testing.
Operate specialized lab equipment: Ovens, PDIV testers, Voltage Breakdown testers, Microscopes, and other mechanical/electrical test units.
Analysis & Documentation: Interpret test results against customer/internal specs (e.g., ISO 9001/IATF 16949).
Accurately document results.
Quarantine non-conforming materials.
Lab & Equipment Maintenance: Maintain lab equipment in good working order.
Keep the Enameled Wire (EV) Lab clean, safe, and organized (wiping surfaces, sweeping, disposing of waste).
Communication & Coordination: Report quality issues, problems, or concerns immediately to the Quality Manager/Supervisor/Engineer.
Coordinate with production supervisors/operators to obtain samples and communicate test results, especially when issues arise.
Procedures & Safety: Follow lab operating procedures strictly.
Suggest improvements as needed.
Work safely at all times.
Essential Qualifications (Must-Have) Education: High School Diploma or equivalent (Associate's degree or relevant college coursework is a plus).
Technical Skills: Proficient in basic math and computer use (especially Microsoft Office).
Physical Ability: Lift up to 50 lbs.
Push/pull up to 225 lbs.
Bend, stoop, climb, reach.
Vision: 20/20 corrected vision.
NOT colorblind.
(Critical for identifying wire coatings/defects).
Personal Skills: High attention to detail, ability to maintain a clean/organized workspace, good verbal & written communication skills.
Work Ethic: Energetic, adaptable to a fast-paced environment, able to follow priorities set by management.
Highly Desired Qualifications (Will Strengthen Application) Experience: 1-5 years experience in a laboratory or manufacturing testing environment.
Quality Systems: Knowledge of ISO 9001 / IATF 16949 requirements.
Technical Knowledge: Understanding of electronic/electrical testing principles.
Manufacturing Knowledge: Awareness of basic manufacturing good practices.
Systems: Familiarity with Sam Dong Ohio's ERP system (ERPLx).
Work Environment Fast-paced Quality Assurance lab focused specifically on Copper Enameled Wire (CEW).
Requires precision, adherence to procedures, safety awareness, and physical activity.
Schedule: Monday to Friday 7am to 3pm Please call to our Nesco Resource office for more information at 74
COM110 Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
- Fri/ 6am
- 2:30pm Description: Job Summary: This role is responsible for assembling mechanical, electrical, and electronic components, performing testing and calibration, and ensuring compliance with quality and regulatory standards.
Candidate will work efficiently to meet daily build goals and contribute to a culture of quality and continuous improvement.
Key Responsibilities Assemble instruments and components using hand/power tools, fixtures, and limited automated equipment.
Perform testing, calibration, and verification to ensure product accuracy and reliability.
Inspect components and finished products for compliance with FDA and ISO standards.
Troubleshoot production issues and collaborate with engineering, quality, and product development teams.
Document production activities, including material control and non-conformance reports.
Adhere to SOPs, cGMPs, QMS, and safety regulations.
May train other assemblers based on demonstrated proficiency.
Perform other duties as assigned.
Required Qualifications Ability to interpret technical drawings, instructions, and specifications.
Skilled in using hand and power tools (e.g., screwdrivers, wrenches, measuring equipment).
Strong verbal and written communication skills.
Basic computer literacy and mathematical comprehension.
Good hand-eye coordination and mechanical aptitude.
Ability to lift 50 lbs or more.
Preferred Experience Prior experience in regulated manufacturing environments (e.g., FDA, ISO).
Familiarity with GMP and quality systems.
Education: High School Diploma or equivalent required]
In this role you will serve as an advanced technician supporting the Global Instruments Quality organization.
RESPONSIBILITIES : Perform advanced troubleshooting, repairs, and final acceptance testing on medical devices, including cleaning, decontaminating, disassembly, and final assembly, while adhering to Electrostatic Discharge (ESD) and safety procedures.
Resolve complex problems by gathering, analyzing, and interpreting data with high accuracy and insight.
Demonstrate financial responsibility by independently approving repairs up to $2,000.
Make cost-effective decisions to ensure efficient and budget-conscious repairs.
Provide advanced support to other technicians and lead technical training sessions.
Work autonomously with minimal supervision, effectively managing tasks and making informed decisions independently.
Assist Lead Technicians with advanced repairs.
Handle and maneuver small components and parts.
Analyze calibration and service data to verify compliance with acceptance criteria.
Oversee the processing, review, and routing of Purchase/Work Orders for approval, ensuring efficiency and accuracy.
Complete detailed test records and work orders according to procedures with high accuracy and timeliness.
Lead routine cleaning, decontamination, and surveillance testing of lab space in accordance with Standard Operating Procedures (SOPs).
Inspect equipment, standards, parts, and mechanical components for errors, flaws, and certification/calibration status prior to use, and recommend improvements.
Ensure strict compliance with industry standards and best manufacturing and documentation practices.
Complete assigned training curriculum prior to due dates to avoid late training instances.
Troubleshoot and resolve complex technical problems from the product line/process to minimize reject levels and increase throughput.
Maintain accurate records, support the management of spare parts inventory and materials, and provide team members with necessary information to procure replacement parts or special materials required for effective equipment repairs.
BASIC QUALIFICATIONS | EDUCATION: 2-year degree, or equivalent combination of experience and education.
4+ years of diverse experience in high volume production setting adhering to ISO and FDA Regulations Experience operating in an organization adhering to ISO, FDA, or comparable quality systems and regulations.
Ability to read and understand mechanical, electrical and optical diagrams and technical specifications Hands-on electro-mechanical repair, rebuild, field service experience.
Experience with instrumentation in the medical field.
Preferred Qualifications 4+ years’ experience as an electromechanical technician, experience with instrumentation in the medical field.
COMPETENCIES: Skill in using computer applications including spreadsheet, database, and word processing software.
Demonstrates knowledge of applicable safety/quality standard and practices required in the manufacture of Abbott products through personal work habits.
Ability to clearly communicate ideas, problems and solutions to engineers.
Assist in support of electro-mechanical assembly Rebuild mechanical equipment to perform mechanical trouble Diagnose complex mechanical/electrical systems Performing electrical and mechanical maintenance on all equipment Use a variety of mechanical and electrical test equipment Reassembled electro-mechanical equipment for proper output and operation Fabricate, assemble, and test electro-mechanical fixtures Assemble and test electro-mechanical flight systems in a lab environment Correct mechanical and basic electrical problems Verify electrical and mechanical system operation Utilizing electrical/electronic and mechanical skills Defining and documenting maintenance requirements for electro-mechanical fixtures and equipment Build electro-mechanical circuits, wire and program PLC Perform electrical and mechanical maintenance on all equipment and machinery Modify and repair electrical and mechanical equipment and related controls Perform electro-mechanical testing with minimal supervision from engineers or managers Develop and manage electrical and mechanical solutions Interpret mechanical and electrical drawings and schematics Operate equipment within operational capabilities and limitations of electrical/mechanical systems Supporting performance testing, validation testing of electro-mechanical, pneumatic and hydraulic components and systems
- use your entrepreneurial skills and team mindset to come up with data-driven solutions
- build and lead an agile team to deliver the advanced technology that drives the future
- create a culture of trust, encourage diversity of thought and foster leadership in others
- be part of the historic transformation of the automotive industry.
What you'll do...
* Apply engineering principles & analytical techniques to drive continuous improvement to manufacturing processes
* Lead development of interim and permanent corrective actions to resolve quality issues using 8D methodology and structured problem-solving tools
* Play an integral part in the Launch process by establishing and monitoring quality target levels at the workstation level for each build phase to validate workstations readiness.
* Conduct process audits to ensure process adheres to guidelines and specific process standards
* Act as team leader in resolving assembly related concerns. Lead variability reduction and lean manufacturing initiatives and best practices.
* Support ISO 14001 compliance and support internal ISO auditing and compliance as required
* Lead development of solutions for throughput constraints
* Manage and direct statistical process control activities
* Support efficiency planning to ensure workstation are properly set up with quality risks identified and addressed
* Design and develop end of line and in-process test systems for electronic and electromechanical components.
* Collaborate with suppliers and internal teams to procure test equipment and fixtures.
* Support installation, commissioning, and prove-out of test stations on the manufacturing floor.
* Develop and maintain test procedures, documentation, and calibration protocols.
* Troubleshoot and resolve issues related to test equipment performance and reliability.
* Analyze test data to identify trends, improve test coverage, and reduce false failures.
* Ensure compliance with safety, quality, and industry standards.
* Provide training and support to production teams on test equipment usage and maintenance.
* Troubleshoot machinery, automation and controls issues and downtime
* Use software to monitor test systems.
* Reprogram equipment for engineering changes and improvements
* Update program backups for machinery and automation
* Analyze test rejects and develop solutions.
* Read and modify prints and schematics.
* Ensure spare parts are available for test systems.
* Candidates must possess full flexibility and a readiness to consistently work across all established standard, operating, and rotational shift schedules, encompassing day, night, weekend, and holiday shifts
You'll have...
* Bachelors Degree in Engineering
* 2+ years of experience in hardware testing, manufacturing engineering, or test system development.
* Familiarity with PLCs, industrial automation, and test instrumentation (e.g., NI LabVIEW, Python, CANoe).
* Understanding of manufacturing processes and quality control principles.
* Excellent organizational, communication, and interpersonal skills, with the ability to manage competing priorities under tight timelines.
* Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
* Proficiency with KPI management and data analysis (using data to make decisions)
* Strong public speaking and presentation skills
* Familiarity with Lean Manufacturing principles, Root Cause Analysis (RCA), and FMEA processes.
* Ability to work and multi-task in fast paced environment
* Ability to work effectively as part of a team
* Ability to support and launch programs
* Strong Project Management skills and result-oriented mindset
* 3D CAD review abilities (3D Experience, CATIA, or equivalent)
* Understanding of PFMEA and failure mode avoidance principles
* Ability to operate in stressful situations within timing constraints
* Ability to work with minimal direct supervision
* Working knowledge of statistics (control charts, data collecting, GD&T etc.)
* Error proofing
Even better, you may have...
* Masters degree in Engineering or MBA
* Lean Manufacturing and Six Sigma experience
* 8D and 5Why corrective action and problem-solving skills
* Solid understanding of Lean Tools - 5S, Kanban, Poka-yoke, and Value Stream Mapping
* DMAIC and DMADV (DFSS) Project Methodology experience
* Knowledge of FMEA, PPAP, and DOEs
* Demonstrated skills in print reading, tool layouts, and gauging
* Ergonomic analysis knowledge and experience
* Prior experience in a facility start-up or new equipment commissioning environment.
* Six Sigma: Black or Green Belt certified.
You may not check every box, or your experience may look a little different from what we've outlined, but if you think you can bring value to Ford Motor Company, we encourage you to apply!
As an established global company, we offer the benefit of choice. You can choose what your Ford future will look like: will your story span the globe, or keep you close to home? Will your career be a deep dive into what you love, or a series of new teams and new skills? Will you be a leader, a changemaker, a technical expert, a culture builder…or all of the above? No matter what you choose, we offer a work life that works for you, including:
- Immediate medical, dental, vision and prescription drug coverage
- Flexible family care days, paid parental leave, new parent ramp-up programs, subsidized back-up child care and more
- Family building benefits including adoption and surrogacy expense reimbursement, fertility treatments, and more
- Vehicle discount program for employees and family members and management leases
- Tuition assistance
- Established and active employee resource groups
- Paid time off for individual and team community service
- A generous schedule of paid holidays, including the week between Christmas and New Year's Day
- Paid time off and the option to purchase additional vacation time.
This position is a salary grade 7 and ranges from $84,480-141,360.
For more information on salary and benefits, click here: sponsorship is not available for this position.
Candidates for positions with Ford Motor Company must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status. In the United States, if you need a reasonable accommodation for the online application process due to a disability, please call 1-888-336-0660.
#LI-Onsite
#li-RC1
This position provides leadership and oversight of the Account Managers and Billing Specialist while ensuring excellent customer service, accurate documentation and billing, and strong coordination between Sales, Production, and Quality.
This role is ideal for a team-oriented leader who enjoys auditing customer purchase orders and production job travelers, conducting process improvement exercises, collaborating with other departments, and working in a manufacturing environment.
As the leader of our inside sales team, we are seeking someone dedicated to customer satisfaction and accuracy of paperwork, as these are crucial components to our department.
Key Responsibilities Supervise and support Account Managers and Billing Specialist Ensure accurate contract reviews, work orders, material ordering, and job travelers are completed by the team Review orders, routing steps, and audit bill of materials Ability to fill in for any team member as needed Monitor open and past-due orders and ensure timely customer communication Oversee invoicing, document retention, and unbilled shipments Manage customer complaints and resolutions Serve as liaison between Sales, Production, and Quality Utilize ERP system daily to manage work orders, reports, and workflow Attend daily Planning Meetings and collaborate cross-functionally Hire, train, coach, and develop employees Ensure the team has sufficient cross-training in place and up-to-date Conduct performance evaluations and address performance concerns Ensure training documentation and cross-training within the department Participate in Safety, Quality, annual continuing education, and continuous improvement (Kaizen) initiatives First Year Expectations: Become the subject matter expert for all direct reports Excel at ERP use and functionality Improve team order accuracy and reduce rework Strengthen communication and coordination with Production teams Use forecasting and demand planning to guide account managers on blanket POs Increase depth of knowledge and cross-training for each team member Improve customer return/rework resolutions Learn relevant ISO 9001:2015 and FAA regulations Track and present weekly & monthly team metrics Qualifications Minimum 2 years of supervisory experience or completion of applicable on-the-job training Manufacturing environment experience preferred Prior ERP or database system experience required ISO, Kaizen or continuous improvement experience preferred Strong attention to detail and organizational skills Ability to adapt to changing priorities and deadlines Strong communication and leadership skills Ability to read CAD drawings / blueprints Physical Requirements Ability to sit, stand, and walk for extended periods Ability to push/pull up to 25 lbs Ability to reach, crouch, and use hands/fingers Ability to see in color and communicate clearly in English Ability to use Microsoft Office / Google Suite proficiently Ability to use PCs, printers, and other technology standard with an office supervisory role Requirements: Two years of prior supervisory experience is required or completion of on-the-job-training (OJT) with preference placed on prior experience within a manufacturing setting, Prior experience working with an ERP system or CRM database is required, Previous experience working with and implementing Kaizen principles is strongly preferred.
Compensation details: 0 Yearly Salary PI2ac652cdcb32-3959
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Project Manager will be responsible for the leadership of complex cross-functional projects related to the development and/or sustainment of electro-mechanical medical device systems and/or single use catheters. Project assignment is at the discretion of the supervisor and is based on business requirements. Also responsible for all phases of the project, from Concept Development to Product Launch. Develop and drive project timelines, assemble required project teams, track schedule and deliverables, and maintain effective communication throughout the project.
Job Responsibilities and Essential Duties
- Lead cross-functional project teams in support of Class I - III medical devices.
- Monitor and maintain awareness of new and current product regulations and standards.
- Develop and release all project-related deliverables, including project plan, schedule and budget.
- Manage a project within standardized methods and project models such as Waterfall or Agile
- Lead and support execution of technical and/or cross-functional project work
- Ensure the timely release of critical deliverables within the project.
- Ensure all aspects of the project are in compliance to internal procedures.
- Develop and present periodic status reports.
- Effective communication with project stakeholders, local management, and global management
- Demonstrate leadership when facing uncertainty.
- Understanding of group dynamics to influence team members and lead the project.
- Instill confidence through leadership and actions.
- Identify, support, and promote new concepts and initiatives related to Project Management within the organization.
Minimum Requirements
- BS in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalent experience
- Minimum of 3+ years in project lead role or project management role
- Preferred - experience in medical device or other regulated industry.
- Domestic and/or international travel up to 20%
Required Knowledge, Skills and Abilities
- Experience with Microsoft Project, JIRA, Antura or other project management software
- Experience in leading tasks/projects through a structured, phase-gate process
- Lead and manage technical meetings with cross-functional members.
- Excellent interpersonal, verbal, and written communication skills
- Strong technical writing skills; must be well organized, detail oriented.
- Task oriented and driven to complete assignments on schedule.
- Must have the ability to effectively interface with both technical and non-technical personnel.
- Medical Device experience including thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971)
- Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables.
Salary range: $120k - $140k
#LI-LG1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Responsibilities and Essential Duties
- Lead and govern design-related CAPA activities across the R&D organization, ensuring timely, compliant, and effective resolution of complex design, verification, validation, and product performance issues.
- Oversee and review root cause investigations using rigorous, data-driven problem-solving methodologies, and ensure corrective and preventive actions are appropriately scoped, risk-based, sustainable, and effectively linked to design controls, risk management, and product lifecycle processes.
- Ensure CAPA records and documentation are complete, accurate, and audit-ready, in compliance with FDA regulations, ISO 13485, and internal quality system requirements.
- Manage and develop the R&D CAPA team, including setting expectations, prioritizing
- workload, providing technical direction, and coaching CAPA specialists and engineers.
- Provide technical guidance, coaching, and mentorship to R&D engineers and CAPA owners on CAPA processes, best practices, timeline development, SOP adherence, and effectiveness verification planning.
- Serve as the primary R&D CAPA interface with Quality, Regulatory Affairs, Operations, and other cross-functional partners to address systemic and cross-product issues.
- Review and approve CAPA plans, timelines, effectiveness verification strategies, and closure rationales to ensure regulatory robustness and high-quality outcomes.
- Support internal and external audits, inspections, and assessments by providing CAPA documentation (e.g., CAPA storyboards), investigation rationale, and subject matter expertise.
- Act as a CAPA subject matter expert within the R&D organization, driving continuous improvement in CAPA execution quality and consistency.
Minimum Requirements
- Bachelor's degree in Engineering or related technical field; advanced degree preferred.
- 6+ years of experience in R&D within a medical device organization with at least 5 years of CAPA processes and regulatory compliance requirements (FDA, ISO 13485).
- 2+ years of leadership experience managing engineering teams.
- Proven experience in managing CAPA for design and development activities
Required Knowledge, Skills and Abilities
- Expert-level understanding of CAPA methodologies, root cause analysis tools (Fishbone, 5 Whys, FMEA), and risk management.
- Strong leadership and team management skills with ability to influence and drive accountability.
- Excellent analytical and problem-solving abilities with attention to detail.
- Effective communication and presentation skills for all organizational levels.
- Experience with drafting statistically sound sampling plans & acceptance criteria for measuring Effectiveness of implemented actions.
- Proficiency in documentation and electronic CAPA systems, Trackwise preferred.
- Deep knowledge of medical device regulations and design control requirements.
Salary range: $145k - $175k
#LI-LG1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Sr. R&D Engineer - CAPA Specialist is a senior individual contributor responsible for leading complex, design and/or R&D controlled QMS process related Corrective and Preventive Action (CAPA) investigations within the Research & Development organization. This role drives robust root cause analysis, corrective and preventive action development, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement in design and development processes.
Operating with a high degree of autonomy, this position serves as a technical authority and trusted advisor to R&D teams, providing guidance on structured problem-solving, CAPA best practices, and regulatory expectations. While the role does not include people management responsibilities, it plays a critical mentoring and coaching role within the R&D CAPA ecosystem.
Job Responsibilities and Essential Duties
- Lead and execute product design and or Design Controls process related CAPA investigations within the R&D organization, from problem definition through implementation and effectiveness verification.
- Perform thorough and structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.
- Develop and drive robust corrective and preventive actions that are risk-based, technically sound, and aligned with design controls and risk management processes.
- Ensure CAPA documentation is accurate, complete, and compliant with FDA regulations, ISO 13485, and internal quality system requirements.
- Collaborate closely with cross-functional partners-including Quality, Regulatory Affairs, Operations, and Manufacturing Engineering-to address systemic and cross-functional issues.
- Provide technical guidance, coaching, and informal mentorship to R&D engineers and associates on CAPA processes, problem-solving methodologies, and regulatory expectations.
- Support CAPA owners in developing realistic timelines, following CAPA SOPs, and defining appropriate effectiveness verification plans and acceptance criteria.
- Support internal and external audits and inspections by providing CAPA documentation, investigation rationale, and technical explanations.
- Maintain clear traceability between CAPA investigations, corrective actions, effectiveness checks, and related design and risk documentation.
- Identify opportunities to improve CAPA execution quality and efficiency and contribute to broader quality system and R&D process improvements.
- Serve as a technical CAPA subject matter expert within the R&D organization.
Minimum Requirements
- Bachelor's degree in Engineering or related technical discipline; advanced degree preferred.
- 5+ years of experience in R&D engineering within a medical device organization.
- Demonstrated experience managing and executing CAPA activities within product design and development.
- Strong understanding of regulatory requirements, including FDA regulations and ISO 13485.
Required Knowledge, Skills and Abilities
- Expert-level knowledge of CAPA methodologies and root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA) and risk management practices.
- Strong analytical and problemsolving skills with exceptional attention to detail.
- Ability to provide clear technical guidance and support to junior engineers without direct supervisory responsibility.
- Effective verbal and written communication skills for presenting findings across all organizational levels.
- Experience creating statistically sound sampling plans and acceptance criteria for effectiveness verification.
- Proficiency with CAPA and documentation systems; TrackWise experience preferred.
- Indepth knowledge of medical device regulations, design control processes, and quality system expectations.
Salary Range: $115k - $140k
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Apply
Description
At American Packaging Corporation (APC), you'll find the packaging career you've been looking for. With competitive salaries, excellent benefits, 401(k) plans and tuition reimbursement programs, we nurture our employees while advancing and promoting diversity and inclusion. As the leading flexible packaging converter in North America for over a century, APC's longstanding success is fueled from the inside out. We're constantly seeking to improve our internal operations and were named a "Best of the Best" in the Best workplaces in the America's awards for 12 years in a row. It's how and why we engage the best and brightest talent to continue propelling our shared success into the future.
LOCATION: Story City, IA
SUMMARY: We are seeking a motivated Product Development Engineering Intern to support our engineering teams in developing and optimizing flexible packaging solutions. This role provides hands-on experience with material selection, packaging design, testing, and process improvement in a manufacturing environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
* Participate in training, embrace concepts of and actively practice the STOP Safety Program fundamentals to aid American Packaging Corporation's efforts to achieve a zero accident rate.
* Familiarity with the principles and requirements of ISO 9000, ISO 14001, AIB, and SQF.
* Qualify new and alternate materials.
* Monitor Quality Assurance system to ensure that current procedures/testing correlate with customer requirements.
* Update system/procedures as required and develop appropriate procedures to complete assigned projects.
* Manage in-plant trials through conducting pre-trial planning meetings, directing on-line manufacture of trial materials, documenting results of trials and ensuring trial results are met.
* Attend and participate in all company mandated meetings.
* Other duties as assigned.
Requirements
QUALIFICATION REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Pursuing a Bachelor's degree in Packaging Science.
Experience with lab equipment such as tensile tester, heat sealer, etc.
Experience with Microsoft Excel
Ability to gather data competently into a report format
Statistical Experience is optional
LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
MATHEMATICAL SKILLS
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
PHYSICAL DEMANDS
The physical demands described here are representatives of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
American Packaging Corporation is committed to equal opportunity for all, without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. American Packaging Corporation will make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodation would impose an undue hardship on the operation of our business. EOE/AA Disability/Veteran.
If you are interested in applying for an employment opportunity and need special assistance or an accommodation to apply for a posted position, please contact our Human Resources department at:
.
Avantor | NuSil is looking for a Quality Assurance (QA) Specialist to join our Irving, TX team. The Specialist supports daytoday manufacturing processes by independently testing of and releasing products, doing so by assessing quality documentation and following preestablished procedures to determine material dispositions.
What we're looking for
- Education: High School completion or equivalent (GED) is required; Associate or Bachelor's degree is preferred
- Experience: Minimum of 0 years of experience with an Associate or Bachelor's degree; or 1 year of experience in Quality or with Inventory Control Systems (e.g., SAP) and 1+ years of experience with a Product Lifecycle Application (e.g., Agile) with a High School diploma/GED
- Collaboration Tool: Basic Computer Skills (Word, Excel, Outlook)
How you will thrive and create an impact
- Utilize analytical tools such as Gas Chromatography (GC), and other QC/QA laboratory equipment to execute testing, troubleshoot results, and ensure product quality.
- Ensure compliance with company quality standards and industry regulations to maintain quality within the scope of the job description. This includes documentation and reporting.
- Performs routine cleaning and housekeeping duties, ensuring workstations are clean and properly maintained.
- Supports office inventory upkeep, ensuring supplies are properly stocked, labeled, and accessible.
- Controls documentation via tracking tools, replacing documentation with current revisions as appropriate.
- May determine and advise other functions on the implementation of quality standards (ISO).
- Upon request, may produce documents and defends practices during ISO 9001 internal audits.
- Evaluates records for conformance to GDP and recommends corrections to author.
- Independently evaluates data for accuracy and completeness, and releases/troubleshoots data from incoming raw materials and finished products.
- May initiate documentation to move released material and determine product disposition.
- Closes variance reports as appropriate in the inventory control system used in Manufacturing and Quality.
- Generates variance reports or other product related reports in the inventory control system used in Manufacturing and Quality.
- Independently evaluates and releases batches from the shelf-life database in the inventory control system used in Manufacturing and Quality.
- Follows applicable safety procedures.
- Acts as back-up to other team members as needed when assigned.
- Performs other duties as assigned.
#LI-Onsite
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Know Your Rights poster.
3rd Party Non-Solicitation Policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.
