Role: Quality Engineer

Location: Mansfield, MA - 02048

Duration: 12 Months

Job Description:

Essential Duties and Responsibilities:

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close).
• Work with a third party supplier to resolve issues with NC.
• Conduct Internal/Supplier Audits of the facility per ISO-1385 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 nonconformance's, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• It is also understood that an associate may receive special projects outside of this list.

Desired Minimum Qualifications:

• Minimum required education and experience: Bachelor's degree or equivalent, master’s degree with 2+ years of experience
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Certified Internal Audit to ISO-13485.
• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.