Quality Leader - Medical Device NPI & Compliance

Blue Signal Search

Tampa (FL)

On-site

USD 90,000 - 110,000

Full time

14 days+

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

A leading innovator in precision electromechanical systems is seeking a Quality Manager to elevate product quality and operational excellence. This role involves driving quality assurance for new products and overseeing documentation and process validation, ensuring compliance with regulatory standards. Ideal candidates will have strong experience in quality engineering, particularly in regulated manufacturing settings. Join a dynamic team and shape a proactive quality culture.

Qualifications

Proven experience in Quality Assurance or Quality Engineering within medical devices.
Strong command of regulatory standards including ISO 13485 and FDA 21 CFR 820.
Proficiency in statistical process control and corrective action systems.

Responsibilities

Drive quality assurance for New Product Introductions (NPI) with engineering teams.
Lead the development of key quality documentation such as PFMEAs and Control Plans.
Oversee process verification, first article inspections, and establish process capabilities.