What are the responsibilities and job description for the Quality Engineer position at Soho Square Solutions?
Engr 2, Quality – Medical Device/Pharma (Contract)
Glens Falls, NY (onsite) | 1 opening
We're hiring an Engr 2, Quality to support production line transfers for a med device/pharma manufacturer in Glens Falls, NY. This role owns PFMEA creation, component qualification, and test method development and validation from the ground up.
What you'll do:
- Lead PFMEA creation and component qualification for line transfers
- Develop and validate test methods
- Support product launch and initial manufacturing operations
- Create, update, and maintain documentation per FDA/GMP and internal Quality Policy requirements
- Run failure analysis and support manufacturing issue investigations during process development
- Work cross-functionally to solve quality and compliance problems
What you need:
- BS/BA in Chemical, Biochemical, Mechanical, Electrical, or Industrial Engineering, Biological Sciences, Chemistry, or related field
- 3-10 years in a regulated industry (medical device or pharma required)
- Working knowledge of QSR, GMP, ISO, and FDA guidelines
- Minitab and statistical methods experience
- Strong communication skills, works well independently and in cross-functional teams
- Certification a plus: CQA, CQE, SQE, CQM, Six Sigma
Onsite in Glens Falls, NY. Apply directly or message me to learn more.