Job Description
Title: Principal Quality Engineer
Location: Marlborough MA 01752 (Hybrid 3-4days onsite)
Duration: 3+(possible extension or conversion into permanent)
Openings: 1
Pay rate: $69.71/hr
Shift: 1st shift M-F 8-5 EST(normal business hours)
Certification: ASQ Certification preferred & Regulatory Affairs Certification (RAC)
Additional Information
Experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management is preferred
Education:
- Bachelor’s Degree or higher
Experience
- 8+ years of experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management
Preferred Experience
- Experience in working effectively in an FDA-regulated environment
- Experience working with IVD products
- Analytical mindset with attention to detail and a commitment to integrity, product safety, and Quality
- Demonstrated Experience applying medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA).
Work Environment
- Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)
- Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratory
- Required to wear PPE as appropriate when visiting testing locations
- Must frequently respond to text/email communications and will be required to be aware of ergonomic principles
- May be required to travel by airplane /train or drive long distances
- Ability to follow verbal or written instructions and use effective verbal and written communication
Knowledge
- Experience with quality management system development, Design Controls, and risk management