Supplier Quality Engineering Manager - Medical Device
Combination Products start-up in clinical trails for novel life-saving products!
Work from home and excellent benefits package offered!
About Our Client
This client is a rapidly growing medical device/combination products start-up company based in the Waltham MA area which is late in clinical trails and anticipates an FDA approval in 2021. The company's flagship product specializes in a life-saving device used for cancer treatment.
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.
- Lead supplier selection, supplier onboarding and process validation activities at company contract manufacturing sites (including oversight of Master Validation Plans, IQ / OQ / PQ's, pFMEAs, etc)
- Manage the Approved Supplier List for both device and drug suppliers, as well as associated Supplier Controls SOPs and Work Instructions
- Act as a member of company's cross-functional project teams, including Design Controls teams, to provide supplier quality input and drive supplier decisions
- Collaborate with the sustaining engineering team to investigate NCMRs, CAPAs, deviations, complaints, etc. related to product for human use (including both clinical trial and commercially available product)
- Participate in supplier audits on behalf of company (standards in scope include ISO 13485, ISO 11135, ISO 17025, PIC/S, ICH Q7A)
The Successful Applicant
- Bachelor's degree in Engineering required
- Three (3) years of medical device or life sciences experience in Supplier Engineering or Supplier Quality Engineering
- Ability to travel on occasion
- Must have working knowledge of Supplier Controls and Process Validation.
What's on Offer
- Competitive base salary
- Work from home availability!
- Annual bonus and other incentives
- Excellent full benefits package
- Growth opportunity
- Reports up to executive leadership of a rapidly growing device and life sciences company
- Significant company funding
- Novel product portfolio with strong pipeline
- FDA approval anticipation next year