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Supplier Quality Engineer II

Employer
Apex Systems
Location
Saint Paul
Salary
Competitive

View more

Industry
Healthcare
Role
Engineer
Job Type
Long-Term
Hours
Full Time
Supplier Quality Engineer II

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 supplier's manufacturing processes.

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 audits of suppliers to assess compliance with regulatory and our requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.

New Product Development:
  • Supports the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
  • Generates and reviews 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 SOP's.

What we're looking for in you:

Minimal Requirements:
  • BS degree in engineering or technical field with 2-4+ 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, and CAPA.
  • Ability to work independently; 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%. Note: COVID-19 precautions currently restrict travel. Our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.

Preferred Qualifications:
  • Medical device engineering experience preferred.
  • Experience on a materials or service commodity team.
  • Lead auditor of quality systems experience (ISO 13485 or similar).
  • ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.


EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice

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