Quality Assurance Engineer

4 days ago

Saint Paul, Minnesota, United States Collabera Full time
Job Description

Primary Responsibilities:

We are seeking a highly skilled Quality Assurance Engineer to join our team at Collabera. The successful candidate will be responsible for participating in or leading teams in supporting quality disciplines, decisions, and practices.

Key Responsibilities:

  • Lead on-time completion of projects supporting quality and business initiatives.
  • Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
  • Lead Risk Management activities including analyzing field data to update Risk Management File documents such as, Failure Modes and Effects Analysis (FMEA), Hazard Analysis, and Risk Management Plan/Report.
  • Support Test and Inspection Method development including Method Validation activities.
  • Accountable for Design Verification and Design Validation planning and execution, including cross-functional root-cause investigation and resolution activities.
  • Support manufacturing process development and qualification for design changes.
  • Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
  • Lead and support Corrective Action Preventive Actions (CAPAs) in a timely and objective manner.
  • Lead, coach, and mentor junior engineers.
  • Build strong collaborative partnerships with cross-functional teams including Program Management, Research & Development, Regulatory, and Process Development to ensure cross-functional customer needs are met without creating barriers to development cost, time, and scope.

Requirements:

  • Bachelor's degree within an Engineering field or a closely related discipline.
  • 5-8+ years of Medical Device engineering experience and demonstrated use of Quality tools/methodologies.
  • Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
  • Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem-solving, communication, and team leadership skills. Work effectively with cross-functional teams.
  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Multitasks, prioritizes, and meets deadlines while delivering high-quality work.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel occasionally.

Preferred Qualifications:

  • Cardiovascular or other Implantable Medical Device development and/or manufacturing experience strongly preferred.
  • Previous Development Quality Engineering experience.
  • ASQ CQE or other certifications.

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