Medical Device QA Engineer (Supplier Quality | Manufacturing | Compliance)

Minneapolis, MN - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.

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 val...