Quality Manager

Job Title:

Design Quality Engineering Manager Job Summary

The Design Quality Engineering Manager is responsible for Quality and Compliance activities related to Design Controls, Risk, and Post Market Surveillance. This role leads the Design Quality Engineering (DQE) team to ensure that all medical devices are developed, verified, validated, and transferred in compliance with global medical device regulations and industry standards. This role provides technical leadership in design controls, risk management, verification, validation, and post market surveillance.

The Design Quality Engineering Manager partners closely with the R&D, Regulatory, Operations, Supplier Quality, and Marketing teams to support device product lifecycle management.

• Manage and develop a team of quality engineers in the pursuit of team and business goals.
• Lead and oversee design quality activities from concept through commercialization
• Ensure compliance with FDA regulations, ISO 13485, ISO 14971, and other regulations and standards as appropriate
• Drive robust Design History File (DHF) documentation
• Review and approve design documentation including DHFs, DMR elements, test protocols/reports, drawings, specifications, design inputs, outputs, traceability matrices, and design reviews
• Ensure effective design transfer to manufacturing
• Oversee FMEA, hazard analyses, and risk/benefit assessments and ensure risk controls are implemented
• Develop and approve design verification and validation strategies and ensure statistical rigor in sampling plans and protocol design
• Support internal and external audits as the subject matter expert for design controls, risk management, and post market surveillance
• Drive continuous improvement initiatives within the Quality Management System.
• Analyze post‑market data, complaints, and field performance to identify opportunities for design improvement and ensure post market surveillance reporting is completed in a timely manner
• Maintain departmental budget within prescribed limits.
• Foster a culture of quality, technical rigour, and continuous improvement across the organization

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

• Ability to work within a team environment and build relationships within the Quality organization and with cross functional teams
• Proven ability to direct, coach, build, develop and manage a team of professionals.
• Strong knowledge of statistics, design controls, ISO 13485, ISO 14971, and FDA regulations
• Ability to deliver, meet deadlines and be results orientated
• Able to communicate both orally and in written form to multiple levels of the company
• Strong presentation skills

• BS in engineering plus 3-5 years' experience in a Quality Engineering role, or an equivalent combination of education and experience.
• Certified Quality Engineer (CQE).

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