SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract Sr Quality Engineer to join our client's medical device manufacturing team in Mansfield, Ma. Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

*W2 contract only

MUST HAVES:

• Mechanical Engineering background; 6+ years experience minimum in the medical device industry
• Required experience with non-conforming material reports (NC) and Supplier Corrective Action Requests (SCAR)
• Experience with a proven track record of implementing appropriate risk mitigation and handling PFMEAs
• Certified Internal Audit to ISO-13485

JOB RESPONSIBILITIES:

• Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close).
  Work with third party supplier to resolve issues with NC.
• Conduct Internal/Supplier Audits of the facility per ISO-13485 and/or 21CFR820
  develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.