We believe every person deserves a chance for a healthy life, free from illness, and full of possibilities. We see a world full of healing, with viable care options available to those with limited choices today.
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We envision new ways of providing physicians, pharmacists, and nurses with technologies that not only treat chronic diseases but also work to prevent them. We’re looking for team members who are motivated to learn, grow, and innovate while making a meaningful difference for millions of people around the world.
Position: Sr Engineer – Quality Assurance
Department: Quality Control
Location: Bangalore, Karnataka, India
Essential Duties and Responsibilities
- Demonstrate quality assertiveness and can represent the Quality function in various roles such as product support and lifecycle management.
- Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
- Support Risk Management activities for sustaining engineering projects.
- Support post-market activities such as complaint investigation, complaint trending, CAPA, and FCA processes
- Assist in decision making for process improvement efforts
- Support global Renal manufacturing facilities and associated manufacturing and supplier changes
- Preside as a key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries
- ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred Strong interpersonal/communication/influencing/negotiation skills.
- Strong analytical and problem-solving skills.
- Working knowledge of FDA Regulations
- Demonstrated ability to lead others within a small project or investigational environments
- Good technical overview of medical device verification and validation
- Good understanding of FDA QSR Part 820, ISO 13485, EU MDD / EU MDR
- Broad working knowledge of Medical Device Software Development Life cycle and IEC 62304
- Basic understanding of medical device manufacturing process
- Good understanding of requirements for Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation.
Qualification: BS engineering (Mechanical or Electrical engineering preferred)
Experience: 4-10 years in related Quality or Engineering field in the medical products industry.