Engineering Journal Jobs in Wisconsin

Trident Consulting is seeking a " Chemistry Core 3 / Process Chemistry Scientist " for one of our clients. A global leader in business and technology services.

Job Title: Chemistry Core 3 / Process Chemistry Scientist

Location: Milwaukee, WI

Type: Contract

Pay Rate: $23/hr. on W2

Duration: 04/01/2026 to 03/31/2027

Position Summary

The Scientist – Process Chemistry is an integral member of the Innovation Team, responsible for developing new product and process concepts from ideation through commercialization. This role applies principles of organic and organometallic chemistry, along with chemical engineering fundamentals, to create scalable, sustainable, and production-ready solutions.

The Scientist will collaborate cross-functionally with Business Development, Marketing, Sales, Production, Safety, and Quality teams to ensure successful product launches and seamless transfer of technology to manufacturing. The role requires strong technical expertise, adherence to safety and regulatory standards, and a high commitment to quality and ethical business practices.

Key Responsibilities

Technical & Innovation Leadership

• Maintain expertise in organic and organometallic chemistry.
• Stay current with advancements in process chemistry.
• Ideate and formulate new product and process concepts.
• Lead or actively contribute to well-defined project charters.
• Develop and validate technical solutions and prototypes.
• Design and conduct small-scale screening reactions.
• Create sustainable and scalable production processes.
• Document all innovation activities thoroughly.

Process Development & Manufacturing Support

• Develop hands-on expertise in process chemistry.
• Support product launch and post-launch technical follow-ups.
• Transfer validated processes to designated production teams.
• Provide ongoing technical support and troubleshooting to manufacturing.
• Offer technical training to production personnel as needed.

Cross-Functional Collaboration

• Partner with Safety, Quality, Sales, Marketing, and other departments to introduce new products and processes.
• Serve as a technical liaison between R&D and other technical groups.
• Mentor and support junior members of the R&D team.
• Uphold high standards of quality, housekeeping, safety regulations, and business ethics.

Minimum Qualifications

Option 1:

• Advanced degree (M.S. or Ph.D.) in Chemistry or Engineering
• Experience in distillation of organic compounds and design of distillation processes

OR

Option 2:

• B.S. in Chemistry or Engineering
• 3+ years of industrial experience in distillation

Preferred Qualifications

• Experience calculating theoretical plates and selecting appropriate column packing materials
• Strong hands-on experience with Schlenk-line, glove box, and air-sensitive chemistry techniques
• Chemical manufacturing and process development experience
• Experience with Design of Experiments (DoE) methodology
• Understanding of Statistical Process Control (SPC)
• Excellent written, documentation, and presentation skills

• Seniority Level
• Entry level
• Industry
• Wholesale Chemical and Allied Products
• Pharmaceutical Manufacturing
• Employment Type
• Contract
• Job Functions
• Science
• Skills
• Dist

Title: Associate Attorney

Practice Area: Intellectual Property

Location: Madison or Brookfield, WI

Job Overview Boardman Clark is seeking a skilled and experienced Patent Attorney to join our dynamic team. This role involves providing comprehensive legal counsel to our clients regarding the management and prosecution of patent applications, advising on IP strategy, and supporting litigation and licensing matters.

Responsibilities

• Draft, file, and prosecute U.S. and international patent and trademark applications.

• Conduct patentability and freedom-to-operate searching and analysis.

• Collaborate with R&D and engineering teams to identify and protect innovations.

• Advise on IP strategy, portfolio management, and risk mitigation.

• Support IP litigation, licensing, and due diligence activities.

• Monitor competitor IP and industry trends.

Qualifications

• A background in Mechanical Engineering or Electrical Engineering is preferred, although the ideal candidate must be willing and able to practice in more than one technical area.

• Juris Doctor (JD) degree from an accredited law school.

• Active and in good standing with the state bar association.

• Member of the US Patent Bar.

• One to three years of experience in patent prosecution is preferred.

• Exceptional negotiation and communication skills.

• Strong analytical and problem-solving abilities.

• Detail-oriented with excellent organizational skills.

• Ability to work under pressure and manage multiple tasks simultaneously.

• Ability to work collaboratively with other legal professionals and support staff.

“Equal Employment Opportunity/Affirmative Action Employer”.

Why join AVIRE?

Do you have an entrepreneurial mindset? Do you like being part of high growth, high impact environments? Are you looking for an opportunity to lead a world class team intent on providing an unrivalled customer experience? If you have answered yes to these questions, we should connect!

The Avire Sussex, WI team is looking for a highly driven, highly motivated individual to take us to new heights. In this role, you will be responsible for planning, coordinating, and deploying the resources necessary to ensure our manufacturing capabilities grow with the organization focusing on continuous improvement--ensuring that our team is supported to effectively build high-quality products for our customers. Our assembly team is critical to our success as an organization as we produce high quality products that surpass customer expectations. You will be a part of a team of dedicated Production, Shipping and Receiving personnel, Supply Chain professionals, Technical Support Specialists, and Operations experts with the collective goal of supplying high quality products with a best-in-class lead-time exceeding our customer’s highest expectations. Further, you will be a part of a team that has a track record of delivering double digit compound growth while supporting each other. This position reports to the Operations Manager.

What you will do:

1. Sets clear, attainable production-level and cell-level production targets and direct the team to meet these objectives.
2. Manage daily production activities for the assembly cells including scheduling, production quality, material shortages and nonconformance reporting.
3. Manage the production employees, including performance management, health and safety, and individual training & development.
4. Work cross-functionally to ensure effective production processes and align resources to meet both customer & business demands.
5. Work directly with product management to ensure sustainable production for critical products while providing guidance to drive design for manufacturing/design for automation improvements. Facilitates new product integration and manages related engineering changes.
6. Build a culture of continuous improvement to ensure effective labor and materials management are engrained in everyday activities. Support continuous improvement initiatives and implement and evaluate outcomes.
7. Work directly with operational leadership to manage production requirements in alignment with business objectives & strategies and prepare monthly production reports.
8. Maintain production standards to ensure accurate labor reporting and costing.
9. Ensure compliance with local standards and maintains a safe working environment.
10. Perform other duties as assigned.

We want someone who displays:

Action-Oriented Curiosity: You readily take on challenges, and you identify and seize new opportunities. You have an outstanding history of delivering on your projects. You work on the problems that truly need solving, and you effectively challenge the organization to be better. You can cut through the clutter and focus on the priorities that align with organizational objectives.

Collaboration: You embrace the unique experiences, viewpoints, and abilities of your teammates and proactively engage those differences to come to the best possible outcome.

Empowerment: You thrive in an environment where you can make decisions. You do not shy away from taking a stand, and you recognize the importance of challenging the team to ensure that we strive for more. You take responsibility to solve customer problems the first time.

Accountability: You take responsibility for your actions, and you deliver on your commitments.

Inclusion: In all aspects of your work, you treat everyone with respect.

Performance Objectives

1. Cells are functioning effectively and team members are deployed in alignment with the needs of the business.
2. Lean principles are implemented and driven throughout the organization.
3. Performance management, including training & development, is process-driven and implemented consistently throughout the manufacturing team.
4. Plan production schedule and allocate resources to drive efficient, timely output, targeting improved productivity.

Job Skills

• Strong interpersonal and communication skills
• Proven problem-solving proficiency
• Proven ability to lead hourly employees in a manufacturing environment
• Experience in electronics manufacturing a plus
• Experience with KPI metric management and deployment
• Excellent written, verbal, and interpersonal skills to work effectively with diverse groups of people both within, and outside, of the organization.

Qualifications

• Bachelor’s degree in engineering, engineering management, supply chain or a related field
• A minimum of 5 years’ experience in a production environment holding positions of progressive responsibility
• Alternative combinations of education and experience will be considered
• A minimum of 3 years’ experience in a direct management position
• Strong interpersonal and communication skills at all organizational levels
• Strong decision-making skills and results-driven approach
• Proven analytical ability and familiarity with a KPI-driven operations environment
• Proficiency in Lean Principles a plus: Problem Solving, 5S, Flow, Standard Work, Kanban

Who is AVIRE?

Connecting and Protecting People. AVIRE combines 4 market-leading brands (Rath, Janus, Microkey, and Memco) within the elevator and emergency communications industries; currently offering light curtains, area of refuge, emergency telephones / GSMs, and life safety solutions. Each brand has a strong market presence, a unique identity, a distinct product range, and a long, successful history. The group has manufacturing locations in 2 countries, R&D in 2 countries and Sales & Marketing in 8 countries employing over 400 people globally.

AVIRE is part of the Halma group ( ). Halma bets on talent! We are looking for bright, ambitious people to join our team and stay for the long term. With over 50 businesses under its ownership, Halma is a great place to start, advance, or accelerate your career.

Benefits

• Competitive salary
• Organizational bonus plan
• Complete benefits package including health, dental & vision insurance, 401K, paid vacation, paid holidays, and generous parental leave
• Professional development training opportunities
• Company events (i.e. bbq’s, lunches, bowling and much more)!
• 4 x 10 hour schedule Monday – Thursday

Compassion. Accountability. Collaboration. Foresight. Joy.

These are the Aspirus Core Values; and we are looking for the BEST around to join us as we demonstrate those values Every. Single. Day.

Aspirus Health in WAUSAU, WI is seeking a DIRECTOR- SYSTEM FACILITIES MANAGEMENT AND SECURITY to join our MAINTENANCE team!

The System Director of Facilities Management and Security is directly accountable for the staff, management, fiscal responsibility, and operational oversight of multiple departments across the system. This position works collaboratively with Aspirus leadership and executive leadership to ensure the successful creation and oversight of the goals and objectives assigned to the system departments and programs. Has accountability to ensure that all key constituency groups are aligned and achieving strategic business plan implementation.

In addition, this role will have direct responsibility for administrative management, budget and financial management, capital planning oversight and accountability for all operational programs of the hospitals and outlying buildings including, but not limited to, Plant Operations, Grounds and Landscaping, Security, Safety and Emergency Management programs, and Joint Commission standards. Serves as the liaison for Clinical Engineering and Environmental Services.

Experience/Qualifications

• Knowledge of management practices, and hospital maintenance standards and practices normally acquired through completion of a Bachelor’s Degree in Business Management/Administration or Engineering or through work experience of equal equivalence.
• Master’s degree preferred.
• Minimum of ten years’ progressively responsible experience in facilities management, security, safety, emergency management or related field. Minimum of five years of leadership experience required.
• Experience leading multisite and/or system level programs in healthcare or related field.
• Healthcare experience required.
• Excellent oral and written communication skills, interpersonal skills, and facilitation skills are essential.
• Professional certification in healthcare facilities engineering preferred.

Employee Benefits

• Full benefits packages available for part- and full-time status.
• Time away from work accrual.
• Retirement plans available.
• Wellness program for employees and their families.

Our Mission: We heal people, promote health and strengthen communities.

Our Vision: Aspirus is a catalyst for creating healthy, thriving communities, trusted and engaged above all others. As an Aspirus team, we demonstrate caring, we plan to impact the future, work with happiness and enthusiasm, recognize our power to make a difference and improve the health of our communities.

Aspirus Health is a nonprofit, community-directed health system based in Wausau, Wisconsin, serving northeastern Minnesota, northern and central Wisconsin and the Upper Peninsula of Michigan. The health system operates 18 hospitals and 130 outpatient locations with nearly 14,000 team members, including 1,300 employed physicians and advanced practice clinicians. For more information visit .

Interested? APPLY DIRECTLY

Trident Consulting is seeking a " R&D Scientist (Laboratory Technician)" for one of our clients. A global leader in business and technology services.

Job Title: R&D Scientist (Laboratory Technician)

Location: Milwaukee, WI

Type: Contract

Pay Rate: $20/hr - $23/hr on w2

Duration: 04/01/2026 to 03/31/2027

Position Summary

The Scientist – Process Chemistry is an integral member of the Innovation Team, responsible for developing new product and process concepts from ideation through commercialization. This role applies principles of organic and organometallic chemistry, along with chemical engineering fundamentals, to create scalable, sustainable, and production-ready solutions.

The Scientist will collaborate cross-functionally with Business Development, Marketing, Sales, Production, Safety, and Quality teams to ensure successful product launches and seamless transfer of technology to manufacturing. The role requires strong technical expertise, adherence to safety and regulatory standards, and a high commitment to quality and ethical business practices.

Key Responsibilities

Technical & Innovation Leadership

• Maintain expertise in organic and organometallic chemistry.
• Stay current with advancements in process chemistry.
• Ideate and formulate new product and process concepts.
• Lead or actively contribute to well-defined project charters.
• Develop and validate technical solutions and prototypes.
• Design and conduct small-scale screening reactions.
• Create sustainable and scalable production processes.
• Document all innovation activities thoroughly.

Process Development & Manufacturing Support

• Develop hands-on expertise in process chemistry.
• Support product launch and post-launch technical follow-ups.
• Transfer validated processes to designated production teams.
• Provide ongoing technical support and troubleshooting to manufacturing.
• Offer technical training to production personnel as needed.

Cross-Functional Collaboration

• Partner with Safety, Quality, Sales, Marketing, and other departments to introduce new products and processes.
• Serve as a technical liaison between R&D and other technical groups.
• Mentor and support junior members of the R&D team.
• Uphold high standards of quality, housekeeping, safety regulations, and business ethics.

Minimum Qualifications

Option 1:

• Advanced degree (M.S. or Ph.D.) in Chemistry or Engineering
• Experience in distillation of organic compounds and design of distillation processes

OR

Option 2:

• B.S. in Chemistry or Engineering
• 3+ years of industrial experience in distillation

Preferred Qualifications

• Experience calculating theoretical plates and selecting appropriate column packing materials
• Strong hands-on experience with Schlenk-line, glove box, and air-sensitive chemistry techniques
• Chemical manufacturing and process development experience
• Experience with Design of Experiments (DoE) methodology
• Understanding of Statistical Process Control (SPC)
• Excellent written, documentation, and presentation skills

Hiring: Utility Project Manager – Data Center Infrastructure

Milwaukee WI (Onsite)

Start: ASAP | End: 3/12/2027 with possible extension

We are seeking an experienced Utility Project Manager to support large-scale data center infrastructure projects. This role will serve as the single point of contact for all utility-related scope, including transmission, distribution, and substations, supporting high-availability, mission-critical facilities.

Role Overview

The Utility Project Manager will lead scope, cost, schedule, quality, and safety for utility and substation work supporting data center developments. You will collaborate with internal energy teams, engineering, construction, utilities, and AHJs to ensure reliable, on-time energization of data center campuses.

Key Responsibilities

Scope & Stakeholder Management

• Act as Single Point of Contact for all utility and substation scope (transmission, distribution, substations)
• Lead weekly design and site coordination meetings with Energy, Engineering, Construction, Utilities, and AHJs
• Coordinate utility design reviews, approvals, and signoffs using Adobe Sign / DocuSign
• Manage design coordination using latest AutoCAD and BIM 360
• Develop and maintain responsibility matrices and stakeholder contact lists
• Track and manage utility agreements, easements, deeds, and ROW documentation to meet project schedules

Cost Management

• Establish and manage budgets, estimates, contingencies, and not-to-exceed values
• Track purchase orders and report funding status at defined milestones
• Ensure scope validation prior to work execution
• Manage all change orders and scope changes through formal change management processes

Schedule Management

• Develop and publish detailed utility and substation schedules
• Identify critical path activities and maintain zero-float logic
• Track long-lead equipment (LLE) delivery and on-site readiness
• Provide mitigation plans, recovery schedules, and cost impacts for delays
• Publish weekly progress reports with photos and milestone updates

Quality Management

• Conduct weekly site walks and pre-construction walkthroughs
• Verify substation civil and electrical work meets utility and data center standards
• Identify, document, and escalate quality issues proactively

Safety Management

• Champion safety as a core value on all data center sites
• Develop and submit Energization Safety Plans
• Lead pre-energization coordination walks with all stakeholders
• Review and coordinate Methods of Procedure (MOPs)
• Verify downstream scope completion prior to energization

Required Qualifications

• 10+ years of utility experience, including transmission, distribution, and substations
• Proven experience supporting data center or mission-critical infrastructure projects
• Bachelor’s degree in Engineering or Project Management (preferred)
• Strong knowledge of easements, ROW, and utility agreements
• Solid construction project management fundamentals
• Highly organized, adaptable, and comfortable working in fast-paced, high-visibility environments

Disqualifier: Candidates without direct utility experience will not be considered.

Ideal Candidate Traits

• Experience working in hyperscale or campus-style data center environments
• Strong coordination skills across internal teams, utilities, and AHJs
• Ability to manage ambiguity, tight schedules, and multiple stakeholders

Interested?

Apply now or reach out directly to learn more about this opportunity.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.

Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

Dexian | Unlock trajectory changing opportunities.

Unlock business potential with Dexian's comprehensive solutions. Discover staffing, talent development, and valuable resources. Explore now!

Job Title: Manufacturing Estimator

Location: Sheboygan County, WI

Type: Direct Hire

Schedule: Monday - Friday, 7-4

Pay Range: $70k - $95k + bonus

Benefits: Yes. Medical, Dental, Vision, PTO, 401(k), Paid holidays

Summary

Connect Search is hiring a Manufacturing Estimator in Sheboygan County.

Responsibilities

• Prepare detailed cost estimates for new and existing products, including materials, labor, routings, tooling, and outside services.
• Maintain quote sheets with current and accurate cost data.
• Analyze customer specifications to understand manufacturability and cost drivers.
• Quote outside processes and vendor-supplied components as required.
• Ensure timely delivery of quotes to internal teams and customers.
• Update and maintain product cost models on a regular basis.
• Perform periodic material or alloy cost updates and apply to customer-specific pricing.
• Review actual production costs versus estimates to improve quoting accuracy.
• Support Finance and Operations with cost-related analysis and reporting.
• Align product pricing with company strategy and margin targets.
• Participate in customer discussions to clarify technical requirements and manufacturing capabilities.
• Provide sales teams with technical input to support quoting, negotiations, and pricing discussions.
• Translate customer requirements into meaningful process routings and cost structures.
• Create and maintain production routings for new products and revise existing routings when processes change.
• Collaborate with engineering and operations to ensure routings reflect accurate labor, machine time, and material usage.
• Support the onboarding of newly awarded jobs into the ERP system with correct cost, routing, and pricing data.

Qualifications

• 5+ years of experience in manufacturing cost estimating, cost accounting, sales engineering, or similar role.
• Knowledge of manufacturing processes, routing development, and cost structures.
• Ability to read drawings, specifications, and technical documentation.
• Effective communication skills for both internal and customer-facing interactions.

At ABB, we help industries outrun - leaner and cleaner. Here, progress is an expectation - for you, your team, and the world. As a global market leader, we'll give you what you need to make it happen. It won't always be easy, growing takes grit. But at ABB, you'll never run alone. Run what runs the world.

This position reports to: Continuous Improvement Specialist/Lean

In this role, you will have the opportunity to support the deployment of the continuous improvement initiatives, including promoting a culture of continuous learning and improvement. Each day, you will mentor and coach others to achieve operational excellence and drive improved results. You will also showcase your expertise by deploying and leading projects to improve and sustain operations performance.

The work model for the role is: Onsite; New Berlin, WI

This role is contributing to the Motion Drive Products Division.

Your role and responsibilities:

• Coordinate and support Op-Ex and CI initiatives across Operations, ensuring timely execution with measurable results.
• Facilitate Kaizen events, root cause analysis, and value stream map review sessions to identify and eliminate waste via PDCA and DMAIC.
• Track and report on project progress, KPIs, and cost savings using standardized metrics and digital task management platforms & dashboards.
• Partner with production, engineering, quality, and supply chain teams to standardize best practices and drive sustainable improvements.
• Provide training and coaching on Lean, Six Sigma, and other CI tools to build a culture of continuous improvement.
• Assist in investigating non-conformances and support corrective and preventive action (CAPA) processes.
• Collaborate with production, engineering, and quality teams to identify and resolve quality issues.
• Participate in continuous improvement initiatives and lean manufacturing activities

Our team dynamics:

Our teams support each other, collaborate, and never stop learning. Everyone brings something unique, and together we push ideas forward to solve real problems. Being part of our team means your work matters - because the progress we make here creates real impact out there.

Qualifications for the role:

• Ability to demonstrate experience in lean management, advanced problem solving techniques, performance management, Kaizen facilitation and have established the relevant industry skills associated with at least 5 years of experience in a lean manufacturing environment.
• Post-secondary education and professional certifications are a plus.
• Strong communication skills appropriate for all levels of the organization.
• Advanced working knowledge of Microsoft 365 toolkit and a working knowledge of business intelligence software such as Power BI, Minitab, Celonis, etc.
• Yellow or Green Belt Lean Six Sigma certification is required or ability to certify within 12 months of employment.
• Candidates must already have a work authorization that would permit them to work for ABB in the US.

What's in it for you?

We empower you to take initiative, challenge ideas, and lead with confidence. You'll grow through meaningful work, continuous learning, and support that's tailored to your goals. Every idea you share and every action you take contributes to something bigger.

ABB is an Equal Employment Opportunity and Affirmative Action employer for protected Veterans and Individuals with Disabilities at ABB. All qualified applicants will receive consideration for employment without regard to their sex (gender identity, gender expression, sexual orientation), marital status, citizenship, age, race and ethnicity, inclusive of traits historically associated with race or ethnicity, including but not limited to hair texture and protective hairstyles, color, religious creed, national origin, pregnancy, physical or mental disability, genetic information, protected Veteran status, or any other characteristic protected by federal and state law.

For more information regarding your (EEO) rights as an applicant, please visit the following websites:

As an Equal Employment Opportunity and Affirmative Action Employer for Protected Veterans and Individuals with Disabilities, applicants may request to review the plan of a particular ABB facility between the hours of 9:00 A.M. - 5:00 P.M. EST Monday through Friday by contacting an ABB HR Representative at 1-888-694-7762. Protected Veterans and Individuals with Disabilities may request a reasonable accommodation if you are unable or limited in your ability to use or access ABB's career site as a result of your disability. You may request reasonable accommodations by calling an ABB HR Representative at 1-888-694-7762 or by sending an email to . Resumes and applications will not be accepted in this manner.

ABB Benefit Summary for eligible US employees

Go to and click on \"Candidate/Guest\" to learn more

• Choice between two medical plan options: A PPO plan called the Copay Plan OR a High Deductible Health Plan (with a Health Savings Account) called the High Deductible Plan.
• Choice between two dental plan options: Core and Core Plus
• Vision benefit
• Company paid life insurance (2X base pay)
• Company paid AD&D (1X base pay)
• Voluntary life and AD&D 100% employee paid up to maximums
• Short Term Disability up to 26 weeks Company paid
• Long Term Disability 60% of pay Company paid. Ability to \"buy-up\" to 66 2/3% of pay.
• Supplemental benefits 100% employee paid (Accident insurance, hospital indemnity, critical illness, pet insurance
• Parental Leave up to 6 weeks
• Employee Assistance Program
• Health Advocate support resources for mental/behavioral health, general health navigation and virtual health, and infertility/adoption
• Employee discount program

Retirement

• 401k Savings Plan with Company Contributions
• Employee Stock Acquisition Plan (ESAP)

Time off

ABB provides 11 paid holidays. Vacation is provided based on years of service for hourly and non-exempt positions.

More about us

ABB Drive Products serves the industries and infrastructure segments with world-class drives and programmable logic controllers (PLC). With its products, global scale and local presence, the Division helps customers to improve energy efficiency, productivity and safety.

Quality Engineer

As a Quality Engineer, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the Germantown Manufacturing facility. The Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal and external customers and suppliers.

Below Are Additional Duties And Responsibilities

• Generates, communicates, and implements ideas and solutions.
• Demonstrates accuracy and thoroughness in completing tasks timely.
• Looks for ways to improve and promote quality.
• Monitor Corrective Action System (i.e. Customer Complaints, Supplier, Internal)
• Initiate and investigate Customer Complaints according to our internal procedure and standards.
• Record essential information on internal and/or customer-specific documentation, including updating customer portals.
• Perform investigations using Lean, Six Sigma, and statistical methods to support root cause analysis and corrective actions.
• Identify gaps and/or trends in systems or processes.
• Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from subject matter experts (SME) to implement sustainable solutions.
• Update Quality documents according to our Change Control procedures, as required.
• Verify corrective action effectiveness.
• Drive Non-Conformance Process
• Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab.
• Initiate containment activities, as necessary, with Customer Service and Shipping Department.
• Recommend disposition of product based on thorough investigation and data-driven feedback.
• Initiate and assist Customer Service with Return Material Authorization (RMA) process.
• Develop re-inspection, sort, and/or rework instructions for Manufacturing Operators, as required.
• Collaborate with customer on issuing waiver or deviation documentation and obtain customer approval, as required.
• Maintain the Quality Management System (QMS).
• Understand ISO 13485 Quality management systems requirements.
• Ensure continuing compliance to both internal processes as well as requirements imposed by certification bodies, regulatory agencies, and specific customer requirements.
• Assist in internal, 2nd party, and 3rd party audits.
• Assist with responses and corrective actions for audit findings.
• Support Product Realization process
• Participate in design review, process planning, and failure mode analysis
• Provide input on evaluation of Key Product Characteristics.
• Provide input on gaging methods and equipment.
• Interpret customer requirements including complex blueprints and GD&T call-outs.
• Review and approve Engineering Change Notifications and Verifications
• Evaluate for feasibility and implement updates to customer requirements into associated product control plans, pFMEA, Inspection documentation and other related documents.
• Incorporate industry standard best practices.
• Incorporate lessons learned.
• Evaluate, submit and track Supplier Change Notices to customers and/or suppliers.
• Any other duties as assigned.
• Manufacturing point of contact for the review and disposition of product quality related questions.
• Approve Medical Device release for shipment, as required.
• Perform batch record reviews for medical device prior to release for shipment.
• Generate Certificate of Analysis, as required.
• Release product in ERP system based on customer and process requirements.
• Support Manufacturing process
• Train Manufacturing and Quality Control personnel on customer requirements, inspection techniques, lessons learned, and rework instructions.
• Manage product inspection and testing activities.
• Obtain customer approvals for all required changes based on Quality Agreements.
• Compile supporting measurement and process performance data, as necessary
• Assemble supporting documentation package and review for completeness and accuracy
• Review and approve production documentation updates according to our Engineering Change Order process.