Product Design Quality Sr Specialist I

What You Can Expect

Job Description

Job Summary : Design Quality Sr. Specialist I / Engineer I

Ensures Zimmer Biomet and compatible products meet regulatory, quality, and customer requirements throughout the design and development process, and product lifecycle. Collaborates cross-functionally and with external partners to achieve Zimmer Biomet’s quality and business objectives.

How You'll Create Impact

Principle Duties and 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.

Principle Duties and Responsibilities:

• Ensure compliance with global regulations and recognized 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.
• Supports 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.
• Analyze quality data to identify trends and improvement areas.
• Support quality improvement initiatives.
• Support root cause investigations and CAPA activities.
• Supports design transfer and sourcing transfers with Supplier Quality counterparts.
• Supports customer complaints investigations.
• Management of product nonconformance, hold and field action records and activities.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

Expected Areas of Competence (i.e., knowledge, skills and abilities)

• 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 analysis 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

Your Background

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

Physical Requirements

Travel Expectations

Up to 20%