Quality Specialist - Design Validation

As a Quality Engineering Specialist within the Medline UNITE Foot and Ankle Orthopaedics Division in Pune, India, you will play a crucial role in maintaining quality standards aligned with strategic engineering objectives. Your responsibilities include providing quality support for complaint investigations, routine product evaluations, product testing, documentation, and vendor qualification processes. Additionally, you will contribute to new product development and legacy engineering projects related to implantable foot and ankle products and accessories. Your ability to thrive in a team environment, demonstrate a strong sense of urgency, and build effective working relationships with peers, customers, and suppliers is essential for this role. You will report to the QRA Manager in India and the Quality Manager in the United States. Key Responsibilities: - Evaluate supplier documents for missing information and develop biological evaluation plans and reports - Build product documentation in compliance with regulations to support Design Control and Risk Management activities - Contribute to the construction and completion of DHFs, DMRs, and product specifications - Assist in customer complaints and ensure compliance with testing requirements - Create and maintain inspection procedures - Provide supporting information for technical documentation to the Regulatory team Additional Responsibilities: - Maintain quality levels and minimize defects and failure rates - Support Quality Engineers and Vigilance Teams on incidents and customer complaints investigation - Assist in other Quality and Regulatory areas as necessary Qualifications Required: - Degree or higher in B. Tech (Biomedical)/ B.E. (Mech)/ M. Pharm. (Quality Assurance) - 5 to 7 years of work experience in the Medical Device industry with a strong Quality background - Familiarity with 21 CFR Part 820 or ISO 13485 design requirements - Proficiency in ISO 14971, ISO 10993, and other relevant ISO standards - Excellent communication skills and proficiency in MS Office - Strong attention to detail and organizational skills Working Hours: - 10.30 am to 7.30 pm (daylight saving) - 11.30 am to 8.30 pm (non-daylight saving),