Quality Engineer I
- Posted 14 days ago
- Be among the first 30 applicants
Job Description
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 Summary
The Quality Engineer is an entry level position responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
How You'll Create Impact
Principle Duties And Responsibilities
Your Background
Education/Experience Requirements
Travel Expectations
EOE/M/F/Vet/Disability
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 Summary
The Quality Engineer is an entry level position responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
How You'll Create Impact
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.
- 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.
Your Background
Education/Experience Requirements
- Bachelor's degree with 1-3 year's of related experience.
- Familiarity with 21 CFR 820/ISO13485/IEC 62304 and other government/ISO standards preferred.
- Experience in regulated industries.
- Medical device experience preferred.
- Strong computer skills (MS Office Suite and Adobe).
Travel Expectations
EOE/M/F/Vet/Disability
More Info
Key Skills
About Company
Skills:
Quality Systems, design control, Statistics, Iso 13485, 21 CFR 820, Risk Management, Design for Manufacturability, EN Requirements, Six Sigma, Design to Cost
Skills:
Technical Documentation, Defect Management, Product Quality and Reliability, Iso 14971, IEC 62304, Iso 13485, Data Analysis Interpretation, Continuous Improvement, CAPA Methodologies, Design Quality Management, Product Test Design, Privacy Safety and Security Risk Assessment, IEC 60601-1, Regulatory Requirements, EU MDR, Design Verification Planning, Design Validation Planning, IEC 62366
Skills:
Root Cause Analysis (RCA), Product Lifecycle Management (PLM), Design for Quality (DFQ), Technical Documentation, Defect Management, Iso 14971, Product Quality and Reliability, Iso 13485, IEC 62304, Data Analysis Interpretation, Continuous Improvement, Design Quality Management, CAPA Methodologies, Product Test Design, IEC 60601-1, Privacy Safety and Security Risk Assessment, Regulatory Requirements, EU MDR, Design Verification Planning, People Management, Design Validation Planning, IEC 62366
Skills:
Plm, Fmea, Spc, CAD, APQP, Minitab, Ppap, Msa
Skills:
IQ OQ PQ, Optical comparators, Fmea, Process Control, Product testing methods, Statistics, Cmms, Geometric Dimensioning and Tolerancing, qsr, ISO regulations, Design assurance, Blueprint Reading, Process Capability, Verification and validation concepts, Project management techniques, Microsoft Office Suite