Medical Device QA Engineer (Supplier Quality | Manufacturing | Compliance)
Medical Device QA Engineer (Supplier Quality | Manufacturing | Compliance)
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1 Vacancy
Job Description
Medical Device QA Engineer (Supplier Quality Manufacturing Compliance)
Location - Minneapolis (Arden Hills and Maple Grove)
Job Type: Contract
Seeking Supplier Quality Engineers with 3 years experience in medical devices or regulated industries. Role involves supplier audits CAPA/SCAR process validation sustaining engineering and new product development support. Engineering degree required.
About the role:
The Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our suppliers manufacturing this role you will support SFMD products within the Relievant acquisition in the Neuromodulation division with a primary focus on Single-Use Devices and Capital Equipment accessories.
Your responsibilities include:
Sustaining Engineering:
- Evaluates and communicates quality issues to suppliers and applies sound systematic problem-solving methodologies in identifying prioritizing and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
- Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
- Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements including audit scheduling investigation and evaluation of audit observation and findings reporting follow-up and confirmation of follow-up actions.
- Manages sustaining quality issues process change impacts and design change implementations for suppliers within the Relievant Quality system the hybridized BSC-Relievant Quality System and in the BSC Quality System after products are successfully integrated.
- Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
- Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
- Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-related.
- Supports Supplier Change Impact Assessments for process changes at suppliers.
- Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
- Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.
New Product Development:
- Execute SFMD Plan deliverables for integration of acquired companys suppliers and products into BSCs Quality System.
- Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
- Generate and review quality plans agreements product specifications component qualifications design verification/validations and process validations.
- Quality System Champion:
- Collaborates with corporate and regional supplier quality organizations on policy procedure and guideline development. Includes generation review and implementation of these documents.
- Identifies and advises management on potential improvements to quality systems and processes in the company.
- Champions 100% compliance to company policies and SOPs.
Required Qualifications:
- BS degree in engineering or technical field with minimum of 2 years of relevant experience.
- Experience in medical device automotive aeronautical semiconductor or other regulated industry.
- Project management: ability to influence cross functional global teams spanning Quality Operations R&D and Sourcing.
- Experience in process validation design controls risk management CAPA SCAR.
- Organized and self-driven.
- Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
- Ability to rapidly learn and use new software applications (e.g. PLM ERP).
- Domestic and international travel up to 25%.
Preferred Qualifications:
- 3 years of medical device engineering experience preferred.
- Medical Device Industry experience
- Problem Solving and Project Management experience
- Leadership experience on a materials or service commodity team.
- Lead auditor of quality systems experience (ISO 13485 or similar).
- ASQ certification (CQE CBA SSGB SSBB) desired.
Employment Type
Full-time
