Supplier Quality Engineer

Supplier Quality EngineerThe 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.ResponsibilitiesSupport 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.Develop and execute process characterization and process validation activities, including IQ, OQ, and PQ, as applicable.Develop and execute test method validation activities to ensure reliable and repeatable measurement systems.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.Support investigation and documentation of deviations, anomalies, and unexpected test results.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.Perform or support root cause investigations and develop appropriate corrective and preventive actions.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.Develop and revise procedures, work instructions, forms, and other controlled documentation as needed.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.Essential SkillsBachelor'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 supporting or executing process validation activities such as IQ, OQ, and PQ.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.Demonstrated ability to analyze technical problems, identify root causes, and implement effective corrective and preventive solutions.Ability to manage assigned projects and deliverables with limited supervision while maintaining strong collaboration with cross-functional teams.Strong technical writing skills for clear and accurate documentation.Effective verbal communication and cross-functional collaboration skills.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.Additional Skills & QualificationsExperience supporting Class II or Class III medical devices.Experience with implantable, cardiovascular, catheter-based, or tissue-based medical devices.Experience with Design Controls and Design Verification and Validation.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.Familiarity with EU MDR and MDSAP requirements.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.Job Type & LocationThis is a Contract position based out of Maple Grove, MN.Pay and BenefitsThe pay range for this position is $48.00 - $58.00/hr.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.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan – Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)