Quality Engineer II
3 month contract
Raynham, MA - onsite 5x a week
Required Skills & Experience
Industry: Minimum of 4 years of experience in medical device manufacturing or other highly regulated industries. Understanding of investment casting (foundry processing) is preferred but not required.
Validation: Strong background in process validations (IQs, OQ/PQs, TMVs) is required.
Quality & Compliance: Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements). Raises Quality issues as appropriate. Proficiency in conducting non-conformance investigations and maintaining non-conformance records; strong investigation skills and ability to manage multiple investigations are essential. Experience in supporting Corrective and Preventive Actions (CAPA) preferred but not required; includes Action Plan (AP) and Effectivity Monitoring (EM) tasks.
Change Control: Experience with change control processing via PLM systems, good documentation practices (tracking edits between revisions), solicit review feedback and approvals.
Self-Starter: Demonstrated ability to work independently and proactively. Must be a team player and not shy about engaging with colleagues.
Job Description
Complete validation & quality actions required for the introduction and delivery of new Hinge cast product line as well as support EUMDR validation assessment and rationalization.
Compensation: $38-50/hr depending on experience Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.
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