Job Description
The Principal Quality Engineer will support the VP of Quality and Regulatory Affairs in developing and maintaining a quality system compliant with ISO 13485 and FDA 21 CFR Part 820.
Key responsibilities include managing document control functions, representing quality at functional team meetings, participating in risk management processes, and ensuring customer complaints are addressed compliantly.
The Principal Quality Engineer will also manage and implement CAPA systems, maintain internal audit systems, and support supplier management programs.
Additionally, this role will involve preparing reports, documents, procedures, specifications, and other technical documents required to ensure project success.
A key aspect of this position is supporting continuous improvement of quality system processes and business operations.
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Required Skills and Qualifications
* Bachelor's degree in Science or Engineering
* A minimum of eight years' experience in quality engineering or regulatory roles, preferably in the medical device industry
* Excellent written, interpersonal communication, and presentation skills
* Able to effectively present information to peers
* Solid grasp of team dynamics
* Holds self and others accountable to meet commitments
* Able to prioritize and focus on critical objectives
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About This Opportunity
This is an exciting opportunity for a seasoned quality professional to join our team and make a meaningful contribution to our organization's success.
We offer a dynamic work environment, opportunities for professional growth, and a chance to work on challenging projects that align with your skills and interests.
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What We Offer
In addition to a competitive compensation package, we offer a range of benefits, including professional development opportunities, flexible work arrangements, and a collaborative work environment.