Sr Quality Engineer

Preferred Qualificationsnice to have

• Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.
• Experience: Regulated engineering field
• Industry Experience: Medical device industry.
• Technical Skills: Proficient in quality management systems, risk management, regulatory compliance, and statistics.
• Other: Basic knowledge of human anatomy/physiology and surgical procedures

• Collaborating cross-functionally to ensure the utmost product quality for patient safety
• Creating and maintaining the risk management file, including the risk management plans and reports, as well as conducting regular risk reviews.
• Leading hazard and risk analysis activities to identify potential risks and implement effective risk control measures.
• Leading Design Failure Modes and Effects Analyses (DFMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.
• Analyzing and reviewing product complaints to anticipate and prevent future issues.
• Integrating product security measures to protect against potential vulnerabilities into the risk management file.
• Participating in Process FMEA/User FMEA development and integrating the Process FMEA/User FMEA into the risk management file.
• Leading design review and maintaining the risk management file throughout the product lifecycle
• Developing and managing post-market surveillance plans to monitor product performance and safety in the field.
• Leading field issue evaluation (including root cause analysis, risk evaluation, product containment strategy) during initial launch.
• Ensuring traceability between risk management file, requirements and design outputs utilizing a requirements management tool
• Evaluate the safety risk implications of design changes

• Lead and mentor teams in the development, implementation, and maintenance of the quality system processes and standards.
• Collaborate with cross-functional teams, to define and implement engineering and statistical processes that ensure product quality and compliance throughout the product lifecycle.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participate in regulatory audits and inspections.
• Oversee design validation and design verification activities of user needs and design inputs, including the development of test plans, protocols, test methods and reports.
• Ensure thorough and accurate documentation including test results, risk assessments, and reports.

• Health, dental and vision insurance

• 401(k) with employer contribution and match

• Paid time off and paid holidays

• Medtronic Incentive Plan (short-term incentive)

• Employee Stock Purchase Plan

• Tuition assistance/reimbursement