Product Design Quality Sr II

Zimmer Biomet; Bengaluru; Vor Ort; INR 1.800.000 - 3.300.000; Vollzeit

Zusammenfassung

Zimmer Biomet in Bangalore seeks a Product Design Quality Sr II/Sr III Engineer to ensure products meet regulatory, quality and customer requirements throughout design and life cycle. You will collaborate with cross-functional teams and external partners to achieve quality objectives.

The role focuses on maintaining DHF/RMF, performing risk management, executing design verification and validation, and guiding CAPA and change control processes, while coaching junior staff in a hybrid work setting.

Qualifikationen

• B.S. in Engineering; CQE/CRE preferred.
• 5–7+ years in Quality Engineering in medical device field.
• Solid foundation in engineering principles; SiMD and SaMD expertise preferred.
• Six Sigma Green Belt preferred.

Aufgaben

• Ensure regulatory, quality, and customer requirements throughout design and development.
• Review DHF and RMF documents and maintain them.
• Identify and mitigate design risks using FMEA and other tools.
• Support design verification and validation activities.
• Assist with regulatory submissions and audits.
• Lead CAPA investigations and root cause analysis.
• Collaborate with cross-functional teams and suppliers.

Kenntnisse

Design controls

FDA 21 CFR 820

ISO 13485

Risk management

CAPA

QMS

V&V planning

Documentation

Cross-functional collaboration

Ausbildung

B.S. in Engineering

CQE or CRE certification preferred

Six Sigma Green Belt preferred

Equivalent education/experience

Jobbeschreibung

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

Job Description

Job Summary: Product Design Quality Sr II or Sr III Engineer

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.

Work Location: Bangalore

Work Mode: Hybrid (3 Days in office)

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.

• Represents Quality team in site meetings.

• Creates project and resource plans for small scale, low complexity projects.

• Ensure compliance with global regulations and recognized standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, IEC 60601, IEC 62304).

• 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.

• Analyse 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.

• Support audit, inspection, and regulatory submission readiness activities as needed.

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.

Your Background

Education/Experience Requirements

• B.S. in Engineering or related field; CQE or CRE certification preferred.

• 5-7+ 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

EOE/M/F/Vet/Disability