Senior Counsel, Product
Nuvalent, Inc.
Quality Engineering Program Manager, Post Market
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $140,800 - $211,200 per year
Job Level
Mid-LevelSenior
About the role
- Leading product escalations across cross functional groups Responsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product Responsible for Design Assurance activities supporting changes to commercial products. Mentor team members through technical problem solving including CAPA investigations and triaging issues. Provide technical knowledge and input into risk assessments when quality issues are being evaluated. Provide front room support during inspections from regulatory agencies ( e.g. FDA, FDB, Notified Body ). Demonstrate the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management. Create strategic plans for driving efficiencies, improving competencies, and developing people to continuously improve function. Provide oversight and expertise in design change control and risk management activities. Ability to communication upstream/downstream high visibility
Requirements
- Bachelor's degree and a minimum of 5 years of relevant experience, or a n Advanced degree with a minimum of 3 years of relevant experience
- 7+ years relevant engineering experience with medical device industry Master’s degree in engineering, science, or business Experience with root cause analysis and leading technical investigations with cross functional groups Working knowledge of multiple quality disciplines, especially reliability, safety and compliance Quality or reliability engineering experience in product development Knowledge and experience of product development processes and design controls Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations
