Clinical Operations Manager
Sonova Group
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
- Lead product escalations across cross functional groups
- Monitor product performance, complaint investigations, and evaluate 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 )
- Communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers
- Create strategic plans for driving efficiencies, improving competencies, and developing people
- 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 an Advanced degree with a minimum of 3 years of relevant experience
- Preferred: 7+ years relevant engineering experience with medical device industry
- Preferred: 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
