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Senior Quality Engineer
About the role
Medtronic's healthcare technology mission drives this Senior Quality Engineer role in Nanakramguda, Hyderabad, India. The position manages supplier qualification, audits, and quality systems to ensure reliable medical device components. Day-to-day work includes leading PPAP execution, driving corrective actions, and supporting new product development with component engineering teams.
What you’ll do
- Qualify suppliers according to company standards and manage the approved supplier list per purchasing control compliance
- Initiate and drive SCAPA's/NCR's for suppliers not performing or adhering to company standards and manage supplier change requests
- Assess supplier performance periodically and drive necessary actions for continuous improvement
- Establish processes to ensure suppliers deliver quality parts, materials, and services
- Lead PPAP execution with suppliers and ensure robust process qualification/validation through IQ, OQ & PQ methodology
- Monitor parts from acquisition through the manufacturing cycle and resolve supplier-related problems as they occur
- Develop and prioritize an auditing schedule to ensure suppliers are audited regularly for GMP and quality standards
- Provide pre-market quality engineering support to NPD in partnership with component engineering and post-market supplier quality teams
What you’ll bring
- Bachelor's degree in Engineering, Science, or Technical Discipline
- 8 to 12 years of quality systems experience
- Supplier management experience
- Strong oral and written communication skills
- Ability to comprehend engineering, physiology, and medical device use principles
- Ability to work under pressure in a fast-paced environment
- Comfortable working with international and multi-cultural groups across time zones
- Accurate work delivery with a sense of urgency
Nice to have
- Previous customer-facing and/or project management experience
- Good interpersonal skills
- Previous experience working with global teams (Aerospace, Defence, Med device, automobile preferably)
- ASQ Quality certification (CQE, CSQP, CQA)
- Working knowledge of Standards, Guidance, and Regulations
- Hands-on experience with Minitab tools
- Exposure to auditing FDA Quality System Regulation & ISO 13485
- Lean Six Sigma Green Belt or Black Belt
Skills
Benefits
- Competitive salary
- Flexible benefits package
- Medtronic Incentive Plan (MIP) short-term incentive eligibility
Education
Bachelors degree in Engineering, Science, or Technical Discipline required