Senior Quality Engineer at Stryker – B.Tech/ M.Tech in Biotechnology candidates can apply!

Senior Quality Engineer at Stryker – B.Tech/ M.Tech in Biotechnology candidates can apply!

Join Stryker, a global leader in medical technologies dedicated to making healthcare better. With a strong focus across MedSurg, Neurotechnology, and Orthopaedics, Stryker develops and delivers innovative products and services that significantly enhance patient outcomes. Through close collaboration with healthcare professionals worldwide, Stryker positively impacts the lives of over 150 million patients each year. We offer a challenging and rewarding work environment where your contributions truly matter.

Job Posting: Senior Quality Engineer – Complaints Handling

• Company: Stryker
• Location: Gurugram, 122001, IN (India)
• Work flexibility: Hybrid or Onsite
• Employee type: Full Time
• Job category: Engineering
• Travel: Approximately 20%
• Relocation: Yes, for eligible candidates

Job Description:

What you will do:

As a Senior Quality Engineer at Stryker specializing in Complaints Handling, you will be a critical member of our Engineering team, ensuring the highest standards of product quality and patient safety. Your responsibilities will include:

• Leading and managing the complaint handling and thorough product investigations processes for Stryker’s medical devices.
• Performing detailed visual, functional, and dimensional inspections of field-returned products to identify potential issues.
• Conducting comprehensive root cause analysis to determine the underlying causes of product complaints and failures.
• Actively participating in risk management and risk assessment activities related to product quality.
• Conducting detailed reviews and analysis of process flow documentation, inspection plans, and measurement techniques to ensure robust quality systems.
• Creating and maintaining essential Post-Market Surveillance (PMS) documentation, including PMS plans, PMS reports, Periodic Safety Update Reports (PSUR), and Trend reports to monitor product performance and safety.
• Undertaking other quality-related tasks and projects as assigned by your manager.

What you need:

Required qualification of a Senior Quality Engineer at Stryker:

• Bachelor’s degree (B. Tech) or Master’s degree (M.Tech) in Mechanical Engineering, Biotechnology, or a related engineering discipline.
• A minimum of 4-7 years of relevant work experience in a quality engineering role, with a strong focus on complaint handling and product investigations.
• Hands-on experience and a thorough understanding of the complaint handling process for medical devices.
• Strong analytical abilities and proven problem-solving skills to effectively address complex quality issues.
• Sound knowledge and applied understanding of Good Documentation Practices (GDP), ISO 9001, and ISO 13485 quality management system standards.

Preferred :

Preferred qualifications of a Senior Quality Engineer at Stryker

• Demonstrated ability to collaborate effectively and build strong working relationships with various cross-functional work groups.
• Self-motivated with the ability to effectively prioritize tasks and manage workload in a deadline-driven environment.
• Proven ability to work effectively within multi-national and cross-cultural teams.

Why join Stryker?

If you are seeking a career with a company that truly values your unique talents, fosters a collaborative and rewarding work environment, and offers opportunities for professional growth, Stryker is the ideal place for you. Our comprehensive total rewards package includes competitive bonuses, comprehensive healthcare and insurance benefits, robust retirement programs, employee wellness programs, service and performance recognition awards, as well as engaging social and recreational activities. Join us in our mission to make healthcare better!