Product Design Quality Sr. Specialist I

Zimmer Biomet · Bengaluru

  • Experience5–9 yrs
  • SalaryNot disclosed
  • Work modeonsite
  • Levelsenior
  • Posted3 Sept 2026
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About Zimmer Biomet

Zimmer Biomet is hiring in Bengaluru in healthcare. This role looks for around 5+ years of experience.

Skills

  • Design controls
  • FDA 21 CFR Part 820
  • ISO 13485
  • ISO 14971
  • EU MDR
  • Risk management
  • FMEA
  • Statistical data analysis
  • CAPA
  • Root cause analysis
  • Technical documentation
  • Design verification and validation
  • Quality management systems
  • Continuous improvement
  • Human factors usability studies

The role

A quality engineer at a medical device company applies medical device quality, design controls, and risk management to product development and change control, with design verification and validation and statistical data analysis supporting compliant products. The role also uses technical documentation and CAPA.

Full job description

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.