Development Quality Assurance Specialist
2 weeks ago
Collabera is seeking a highly skilled Development Quality Engineer to join our team. As a Development Quality Engineer, you will be responsible for ensuring the quality of our medical devices from design to delivery.
Key Responsibilities:- Participate in or lead teams in supporting quality disciplines, decisions, and practices.
- 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.
- Support Test and Inspection Method development including Method Validation activities.
- Accountable for Design Verification and Design Validation planning and execution.
- Support manufacturing process development and qualification for design changes.
- Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance.
- Lead and support Corrective Action Preventive Actions (CAPAs) in a timely and objective manner.
- Lead, coach, and mentor junior engineers.
- 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.
- 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.
- 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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