Product Design Quality - Sr. Specialist I

Responsibilities

• Works as part of a team and individually, completing Quality tasks in the design and development and change control processes.
• Coaches and mentors less experienced peers.
• Leads team member training. Serves as site SME for at least one process.
• Represents Quality team in site meetings.
• Creates project and resource plans for small-scale, low complexity projects.
• Ensures compliance with global regulations and recognised standards (e. g., FDA 21 CFR Part 820 ISO 13485 ISO 14971 EU MDR).
• Review, maintain and approve Design History Files (DHF) and Risk Management Files (RMF).
• Identify and mitigate design risks using FMEA and other tools.
• Support design verification and validation activities.
• Support design and change control processes.
• Collaborate with design teams to embed quality standards.
• Author, review and approve documentation in Quality capacity.
• Define and control Critical to Quality (CTQ) characteristics.
• Assist with regulatory submissions and audits.
• Analyse quality data to identify trends and improvement areas.
• Support quality improvement initiatives.
• Support root cause investigations and CAPA activities.
• Support design transfer and sourcing transfers with Supplier Quality counterparts.
• Supports customer complaints investigations.
• Management of product nonconformance, hold and field action records and activities.

Requirements:

• Proficient in design controls, verification, validation (design, process and software).
• Experienced with FDA 21 CFR 820.30 ISO 13485 EU MDR and other global regulations.
• Skilled in risk management (ISO 14971 FMEA, statistical tools).
• Strong QMS knowledge and continuous improvement focus.
• Capable in V& V planning and execution, including human factors usability studies.
• Proficient in statistical data analysis.
• Experienced in CAPA, root cause analysis, and quality improvement.
• Skilled in technical documentation (DHF, test plans, specs).
• Effective cross-functional communicator.
• IT System Skills (Preferred): Windchill, Codebeamer, Jira, Microsoft Office, Minitab, Github.

Education/Experience Requirements:

• B. S. in Engineering or related field; CQE or CRE certification preferred.
• 3-5+ years in Quality Engineering or medical device equivalent experience.
• Solid foundation in engineering principles; preferred expertise in materials science, robotics, SiMD, and SaMD.
• Equivalent education/experience combinations considered.
• Six Sigma Green Belt Preferred.