Senior Staff Engineer, Quality Systems
Senior Staff Engineer, Quality Systems
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Stryker is hiring a Senior Staff Quality Systems Engineer for our Quality Management Systems (QMS) team to support and manage Supplier Quality activities within our Neurovascular division who will be responsible for ensuring an effective and efficient quality management system is built and maintained.
What you will do:
- Lead in developing optimum future state of the QMS processes for business needs aligned with Corporate
- Develop & deliver training and coaching for new QMS users on QMS principles and on the applicable systems
- Lead auditor capable of ensuring compliance with the appropriate internal & external regulatory requirements (including but not limited to Division Corporate FDA ISO MDD and individual country regulatory requirements)
- Coordinates external consultants to perform supplier audits
- Understands Quality Systems & webbased interactions.
- Key contributions to the business process(es) and understands how IT systems support those business processes.
What you need:
Required:
- Bachelors degree
- Minimum of 6 years in Quality or Regulatory Affairs environment with 3 years experience within the area of Quality Management Systems.
- Experience in Quality Systems (e.g. CAPA Audits Management review Quality Planning)
- Experience working as a Supplier Quality Engineer in a Medical Device regulated environment required.
- Experience in interacting with regulatory agencies (FDA BSi etc.).
Preferred:
- Bachelors degree in science or engineering
- Lead Auditor Certified and/or Lean Six Sigma Qualification
Required Experience:
Staff IC
Employment Type
Full-Time
