Sr. Quality Engineer

Strong Medical Device Company

Competitive salary and benefits

About Our Client

Our client is a recognized leader in medical device manufacturing, supplying advanced solutions to numerous major OEM partners. Their capabilities span a wide range of metal-fabricated products, including designs incorporating silicone handle applications. The company produces precision components and devices used in surgical implants, robotic systems, orthopaedic applications, and other critical medical technologies.

Job Description

Plan, coordinate, and execute quality control programs ensuring compliance to ISO13485 and FDA standards

Investigate and address customer complaints - CAPA

Assist with preparing and executing internal and external audits

Handle document and process controls

Update documentation and data within the QMS

Create and direct validations (IQ/OQ/PQ)

Create PPAP documentation

Other duties as assigned

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

5-7+ years of quality experience in medical device

understanding of ISO13485 and FDA standards

Experience with metal fabrication, CNC preferred

GD&T/PPAP experience

Knowledge of QMS software and associated document control

Certifications a plus

Bachelors degree a plus

Sponsorship NOT offered

What's on Offer

Salary ranging from 80,000-100,000+ depending on experience and interviews

3 weeks of PTO- accrues from day one

Full medical benefit plans offered on day one

Ancillary benefits

Company paid holidays

Retirement plans offered

Contact

Max Sinton

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