Manufacturing quality engineering

Job Title: Supplier Quality Engineer

The Supplier Quality Engineer supports product development, manufacturing, process validation, risk management, design controls, and continuous improvement activities for medical devices in a highly regulated environment. This role works cross-functionally with R&D, Operations, Supplier Quality, Regulatory Affairs, and other functions to ensure products and manufacturing processes are developed, validated, and maintained in accordance with applicable quality system and regulatory requirements. The Supplier Quality Engineer applies engineering principles, risk-based thinking, statistical methods, and structured problem-solving techniques to support product and process quality throughout the product lifecycle, and independently executes assigned quality engineering activities while seeking technical guidance for highly complex or novel issues.

Support development and maintenance of product and process risk management documentation, including PFMEAs, hazard analyses, and associated risk assessments.

Facilitate or participate in cross-functional PFMEA activities to identify potential failure modes, process risks, controls, and opportunities for risk reduction.

Ensure identified risk controls are appropriately implemented and supported by objective evidence.

Update risk management documentation in response to design changes, process changes, nonconformances, CAPAs, complaints, and other quality information.

Support development and qualification of manufacturing processes for medical device products, with a focus on supplier and materials-related processes.

Author and review validation protocols, reports, data summaries, and supporting documentation.

Partner with Manufacturing and Engineering to establish appropriate process parameters, acceptance criteria, inspection requirements, and process controls.

Support investigation and resolution of validation deviations and unexpected results using structured root cause analysis.

Apply risk-based approaches to determine appropriate validation requirements and levels of testing.

Support Design Control activities throughout product development and design changes, ensuring quality and manufacturability considerations are incorporated.

Review design inputs, outputs, specifications, drawings, and other engineering documentation for completeness, clarity, testability, and manufacturability.

Support identification and flow-down of critical-to-quality (CTQ) attributes into manufacturing specifications and process controls.

Participate in design reviews and provide Quality Engineering input to cross-functional teams.

Support Design Transfer activities to ensure product and process requirements are appropriately transferred into manufacturing.

Verify that appropriate manufacturing specifications, procedures, inspection methods, acceptance criteria, and process controls are established prior to transfer.

Support planning and execution of design verification and design validation activities.

Review and contribute to verification and validation protocols, test methods, acceptance criteria, sample-size rationale, data summaries, and reports.

Ensure verification and validation activities are appropriately traceable to applicable requirements and risk controls.

Apply appropriate statistical methods to support process development, validation, verification, and quality improvement activities.

Perform and interpret statistical analyses such as descriptive statistics, confidence intervals, capability analysis, GR&R, and other applicable methods.

Support development and execution of Design of Experiments (DOE) and other advanced statistical analyses as appropriate.

Use data to identify trends, evaluate process performance, and support engineering and supplier-related decisions.

Ensure assigned activities comply with internal procedures and applicable regulatory and quality system requirements.

Participate as the Quality representative on cross-functional project teams and technical reviews.

Review and support engineering and manufacturing change controls, including supplier and component changes.

Support investigations of nonconformances, CAPAs, complaints, and other quality issues as assigned.

Support internal and external audits and regulatory inspections by providing documentation and subject matter expertise.

Identify and implement opportunities for process and Quality System improvement.

Help establish and grow the supplier and materials quality function, including supporting vendor assessments and ongoing supplier performance monitoring.

Support onboarding and knowledge transfer to new team members, helping them understand current supplier status and quality expectations.

Bachelor’s degree in Engineering, Science, or a related technical discipline.

• 3–8 years of experience in Quality Engineering, Manufacturing Engineering, Product Development, or a related technical function within the medical device industry or another highly regulated industry.
• Supplier quality work history, including experience with supplier management and component qualification.
• Medical device work history, ideally with catheter- or valve-related products or other cardiovascular and implantable devices.
• Experience working within an FDA-regulated Quality Management System.
• Working knowledge of medical device Quality Engineering principles, including process controls, validation, risk management, and problem solving.
• Experience developing or reviewing technical protocols, reports, specifications, and engineering documentation.
• Working knowledge of relevant standards and regulations, including ISO requirements and FDA Quality Management System Regulation (QMSR), as well as applicable medical device regulatory requirements.
• Working knowledge of statistical methods used in Quality Engineering and manufacturing, including capability analysis, GR&R, and DOE.
• Ability to manage assigned projects and deliverables with limited supervision while maintaining strong collaboration with cross-functional teams.
• High attention to detail and a strong commitment to product quality and patient safety.
• Experience with root cause analysis, CAPA, SCARs, audits, quality assurance, quality control, quality management, corrective action plans, and risk management.
• Experience with PFMEA and other risk assessment tools in a manufacturing or supplier quality context.

Experience supporting Class II or Class III medical devices.

Experience with implantable, cardiovascular, catheter-based, or tissue-based medical devices.

Experience with process characterization, test method validation, DOE, capability analysis, and GR&R.

Experience with component qualification and supplier quality activities, including vendor evaluation and ongoing performance monitoring.

ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt, or equivalent training or certification.

Ability to thrive in a growing organization and help build out supplier and materials quality processes.

Interest in mentoring or supporting new team members as the quality organization expands.

This is a Contract position based out of Maple Grove, MN.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.