Engineering Jobs in Haskell New Jersey
34 positions found — Page 3
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.
JobOverview
The Staff Engineer, Sustainabilityleads sustainability initiatives across product development, operations, and supply chain whileestablishinggovernance frameworks. It ensures measurable environmental impact reductions, compliance with FDA/ISO standards, and trusted performance metrics aligned with business strategy.
Job Responsibilities and Essential Duties
Drive carbon reduction roadmap and eco-design principles.
Lead lifecycle assessments and integrate sustainability into product development.
Collaborate with suppliers on low-carbon initiatives.
Support compliance with ISO 14001, ISO 14040, and FDA standards.
Ensure raw material complianceto include RoHS, REACH, EU MDR Prop65
Define and standardizegovernance & KPI'sacross teams.
Ensure data integrity and consistent reporting.
Build dashboards to track sustainability and performance KPIs.
Review and updategovernanceto align with evolving strategies.
MinimumRequirements
Degree in Engineering, Sustainability,Project Management,or Data&Analytics.
7+years in sustainability, governance, or regulated environments.
Knowledge of lifecycle assessment, ISO frameworks, and BI tools (Power BI, Tableau).
Strong communication, stakeholder management, and analytical skills.
PMP Certification a plus.
Salary range: $98,000.00 - $125,000.00 plus bonus targeted at 10% (depending on overall company performance)
#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.
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 Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.
Job Responsibilities and Essential Duties
- Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
- Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
- Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
- Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
- Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
- Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
- Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
- Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
- Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
- Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
- Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
- Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
- Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
- Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
- Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
- Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
Minimum Requirements
- Bachelor's degree in engineering, Science, or other related field is required.
- Six Sigma Green Belt or other applicable certifications are a plus.
- Minimum 1 year experience in Quality or Engineering.
- Experience in a medical device or pharmaceutical industry.
- Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
- Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
- Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
- Project management and leadership experience is desirable.
- Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Required Knowledge, Skills and Abilities
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
- Ability to work effectively in a cross-functional team environment.
- Ability to review and understand technical standards and their requirements for products.
- Lead improvement initiatives, either independently or as part of cross-functional teams
The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus
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.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
About Ideavillage
Ideavillage is a leading consumer products company behind nationally recognized brands including Copper Fit, MicroTouch, Finishing Touch, and Flawless. We design, develop, and launch innovative hardline items—including grooming tools, shavers, vibration/fitness products, and small battery‑powered devices—distributed across 60,000+ retail locations such as Walmart, Target, CVS, Walgreens, and Dick’s Sporting Goods.
We are expanding our engineering capabilities to support rapid product development with overseas manufacturing partners.
Position Overview
We are seeking a hands‑on Product Engineer with both electrical and mechanical engineering experience to lead the technical development of our growing portfolio of small appliances, grooming tools, vibration devices, and battery‑powered products.
This engineer will partner closely with overseas factories (primarily Asia) to ensure that every new product is engineered for performance, safety, manufacturability, and cost. The role spans concept validation through mass production.
Key Responsibilities
Product Development & Engineering
- Lead engineering efforts across the full product lifecycle: concept → prototypes → EVT/DVT/PVT → production
- Review and refine mechanical and electrical designs (motors, PCBA, wiring, charging systems, battery packs)
- Conduct technical tear‑downs, competitive benchmarking, and feasibility assessments
- Create and maintain technical documentation:
- Specifications
- Engineering drawings
- Test protocols
- Validation reports
- ECNs (Engineering Change Notices)
Factory & Supplier Engagement
- Collaborate daily with overseas factories (China, Vietnam, Thailand, etc.)
- Guide suppliers on design intent, DFM (Design for Manufacture), and tooling considerations
- Support pilot builds, pre‑production runs, and troubleshooting during scale‑up
Testing, Validation & Compliance
- Develop and execute testing protocols for safety, durability, vibration, noise, electrical performance, charging, and reliability
- Support compliance activities (UL, CE, FCC, CSA, Intertek, etc.)
- Perform root cause analysis (RCCA) on failures and implement corrective actions
Cross‑Functional Collaboration
- Work closely with Product Development, QA, Supply Chain, and Leadership
- Communicate technical risks, design changes, timelines, and validation status
Required Qualifications
- Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or related discipline
- 3–5+ years engineering experience in consumer products, small appliances, personal care devices, electronics, or similar
- Strong hands‑on engineering background in both mechanical & electrical systems
- Experience with offshore manufacturing and ODM/OEM development
- Familiarity with regulatory and safety compliance (UL, CE, FCC, etc.)
- Skilled in root cause analysis and corrective action methodologies
- Strong communication skills and ability to produce clear technical documentation
Preferred / Bonus Skills
- Experience with:
- Motors and vibration systems
- Lithium‑ion batteries, charging circuits
- Shavers/grooming tools or similar electromechanical devices
- Proficiency with test equipment: oscilloscopes, multimeters, power supplies, electronic loads, spectrum analyzers
- CAD experience (SolidWorks or similar) a plus
- Mandarin/Cantonese conversation skills a plus (not required)
Travel
- Domestic and international travel: 3–5 times/year for factory visits, pilot builds, and product validations.
About the Client:
Our client is a well-established manufacturing company specializing in industrial production. Known for its commitment to quality, operational efficiency, and collaboration, the company values employees who can contribute to smooth supply chain operations while maintaining high standards. The work environment is hands-on, fast-paced, and focused on delivering results while fostering teamwork and continuous improvement.
Role Overview:
The Safety Manager is responsible for leading and managing company-wide safety initiatives to ensure a compliant, safe, and efficient work environment. This role partners closely with Operations, Engineering, and Human Resources to implement safety programs, reduce workplace risk, and ensure adherence to OSHA, DOT, and applicable regulatory standards. The position is hands-on and plant-facing, supporting daily operations while driving long-term safety improvements.
Job Requirements:
- Bachelor's degree required; focus in Occupational Safety, Environmental Health, Engineering, or related field preferred.
- 3–5 years of safety experience in manufacturing, production, warehouse, or industrial environments.
- Strong working knowledge of OSHA and DOT regulations.
- Experience delivering or coordinating safety training, including forklift, crane operation, and first aid/CPR.
- Experience conducting safety inspections, audits, and incident investigations.
- Familiarity with workers' compensation processes and prevention strategies.
- Ability to travel to company locations as needed.
- Proficiency in Microsoft Office and safety-related software tools.
- Strong analytical, communication, and time-management skills.
Key Responsibilities:
- Develop Safety Programs: Create, implement, and manage comprehensive safety policies and procedures covering employee, equipment, and material safety.
- Ensure Regulatory Compliance: Serve as the internal expert on OSHA, DOT, and industry safety standards to maintain ongoing compliance.
- Deliver Safety Training: Coordinate and conduct safety training programs for new hires and existing employees.
- Conduct Inspections & Audits: Perform regular safety audits across plant, production, and warehouse environments.
- Lead Incident Investigations: Investigate accidents, incidents, and near-misses; prepare reports and corrective action plans.
- Support Workers' Compensation: Monitor claims and assist with prevention and mitigation strategies.
- Manage Fleet Safety: Evaluate fleet safety performance and ensure compliance with transportation safety protocols.
- Report Safety Metrics: Prepare and present safety performance data and compliance updates to leadership.
- Maintain Documentation: Manage SDS files, safety records, compliance logs, and required documentation.
- Support Operations: Perform additional safety-related duties as assigned to support operational needs.
About Grit Staffing and HR Solutions:
GRIT Staffing & HR Solutions is a boutique recruiting and HR consulting firm founded and led by seasoned Senior HR leaders. We partner with leading companies to place high-performing professionals in legal, HR, supply chain, operations, and C-suite roles. Unlike traditional recruiters, we act as strategic partners and extensions of our clients' teams, leveraging our deep HR expertise to support talent strategy, workforce planning, and organizational growth. By combining hands-on experience with agility and insight, we help companies build strong, high-performing teams that drive business success.
GRIT Staffing & HR Solutions is an Equal Opportunity Employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees and applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. If you require a reasonable accommodation during the application or interview process, please contact us at so we can assist you.
Quality Assurance Supervisor
Allendale, NJ
Full-Time | Exempt
Kelly Science & Clinical
Kelly Science & Clinical is seeking a Quality Assurance Supervisor to join an innovative life sciences and manufacturing organization near Allendale, NJ. This leadership role will oversee quality compliance activities, regulatory adherence, and internal quality systems while supporting GMP-regulated operations and continuous improvement initiatives.
This is an excellent opportunity for a quality professional with GMP and regulatory compliance experience who enjoys leading teams, improving quality systems, and ensuring regulatory excellence.
Key Responsibilities
- Supervise and manage the Quality Compliance team, ensuring objectives and compliance activities are completed on time
- Lead deviation investigations and ensure effective CAPA development and implementation
- Support change control processes, ensuring systems, processes, and products remain compliant
- Manage the internal audit program, ensuring findings and corrective actions are completed promptly
- Ensure compliance with FDA and ISO regulatory requirements, including ISO 22716 and 21 CFR Parts 210 & 211
- Write, review, and maintain Standard Operating Procedures (SOPs) and GMP documentation
- Manage archival of batch records and quality documentation
- Collaborate cross-functionally to investigate compliance issues and drive resolutions
- Identify potential compliance risks and vulnerabilities, implementing corrective actions as needed
- Provide regular reports and updates to senior leadership on compliance performance
- Support validation activities to maintain compliance with FDA and cGMP regulations
Qualifications
- Bachelor’s degree in Chemistry, Biology, Environmental Science, or related field
- 5+ years of experience in Quality Assurance or Compliance within a regulated environment
- Strong knowledge of GMP, quality systems, and risk management principles
- Experience leading deviation investigations, CAPA processes, and internal audits
- Strong technical writing skills with the ability to review and author investigations and SOPs
- Proven leadership abilities including coaching, conflict management, and team development
- Strong communication and organizational skills
Preferred:
- Experience working with FDA and Health Canada regulations
- Bilingual (English/Spanish)
What You’ll Bring
- Expertise in GMP-regulated quality environments
- Ability to lead teams and manage complex compliance initiatives
- Strong analytical and problem-solving skills
- Commitment to maintaining high standards of quality and regulatory compliance
Junior Project Engineer (Design Controls)
Location: 100% ONSITE - Mahwah, NJ (07430)
Type: W2 contract (NO C2C OR THIRD PARTY)
Duration: 12 month contract - Contract extension potential)
Pay Rate – Negotiable depending on DIRECT-related experience up to $33.75 - $36.06 an hour
Work Authorization: Must be physically located in United States and have United States employment authorization documents WITHOUT CURRENT OR FUTURE sponsorship requirements. Sponsorship is NOT available NOW or in the FUTURE for this role.
JOB SUMMARY:
- Assist in providing oversight to sustaining engineering teams with respect to implant and instrument design work.
Duties Include:
- Model and detail implant and instrument designs utilizing ProE/Creo design software.
- Demonstrate technical protocol and report writing skills.
- Work on cross-functional design teams to address design and manufacturing changes and maintain existing designs.
- Utilize knowledge of the surgical procedure in order to develop innovative solutions to solve / satisfy customer needs.
- Support FDA and world wide submissions through design rationales and compliance to industry standards with an international team.
- Research legacy testing and design controls for evidence required.
- Perform tolerance analysis
- Draft technical memos
Required:
- Bachelor’s degree in a science or engineering discipline. (Mechanical or Biomedical Engineering preferred.)
- 1-2+ years of product design experience in medical device industry or other regulated industry
- Experienced in design controls and risk management within a regulated industry.
- Experienced with a parametric CAD design package. (Prefer ProE/Creo)
- Expertise with Finite Element Analysis (FEA) and its application, or expertise in other scientific or engineering discipline.
- Demonstrated ability to effectively communicate engineering principals to all levels within the organization through oral and written means.
Important information: To be immediately considered, please send an updated version of your resume to
*** (Kelly Services does not expense relocation/interview costs)**
Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.
Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.
What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.
Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.
Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.
Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.
Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.
Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.
Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.
Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.
Specific options depend on the Sailor's status, training, and current Navy policy.
Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.
Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.
Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.
Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.
Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.
It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.
Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.
