Quality Engineer Jobs at Stryker—Apply Now for AQE Roles
Quality engineer jobs at Stryker offer excellent opportunities for professionals seeking impactful life science jobs within a global medical technology leader. This Advance Quality Engineer position allows candidates to work with robust quality systems, risk management frameworks, ISO standards, and new product development processes in an innovation-driven environment.
- Position: Advance Quality Engineer
- Location: Gurugram, IN
- Job Req ID: R554261
ABOUT THE COMPANY:
Stryker is a global leader in medical technologies dedicated to improving healthcare worldwide. The company delivers innovative products and services across MedSurg, Neurotechnology, and Orthopaedics, positively impacting over 150 million patients annually. Known for its award-winning culture, Stryker offers total rewards, healthcare benefits, performance programs, and a dynamic workplace that values diverse talents.
JOB OVERVIEW:
The Advance Quality Engin
eer position at Stryker involves supporting new product development through risk management, supplier qualification, quality planning, and compliance with ISO and regulatory standards. The role requires experience in quality systems, FMEAs, process validation, and data analysis. This hybrid Gurugram-based role is ideal for candidates seeking quality engineer jobs within the medical device sector and offers strong career growth for professionals from engineering and life science backgrounds.EDUCATIONAL REQUIREMENTS:
- Bachelor’s degree in Biomedical, or Biotech Engineering
- Good understanding of Quality Management Systems (ISO 13485, 21 CFR 820)
- Minimum 2–6 years of relevant experience
- Experience in NPD processes and phases of new product development
- Knowledge of ISO 14971, IEC 62366, 60601-1 standards
KEY RESPONSIBILITIES:
- Responsible for risk management and risk assessment as per ISO 14971
- Create and analyze Risk Tables, FMEAs, Quality Plans, Literature Reviews, Device Master Records, and Technical Files
- Participate in supplier selection, validation, and contract development
- Support operations teams to maintain internal and external supply chains
- Develop inspection procedures for new product development
- Lead quality data trending and analysis
- Author and review procedures ensuring GMP and ISO 13485 compliance
- Support NPDP activities with good documentation practices
- Lead product quality related projects and resolve quality issues
- Support process validation programs for NPD
- Collaborate with engineering teams to build verification test strategies
SKILLS REQUIRED:
- Strong analytical and problem-solving abilities
- Expertise in NPD and risk management practices
- Excellent communication and presentation skills
- Ability to work with cross-functional and multinational teams
- Experience handling AQE function and delivering multiple projects
This Advance Quality Engineer role at Stryker is an excellent opportunity for individuals seeking advance quality engineer jobs that combine innovation, technical leadership, and life science industry exposure. It offers a chance to contribute to impactful global healthcare solutions while developing in a world-class engineering environment.
