Quality Engineer at Integrated Resources, Inc ( IRI )

Title: Quality Engineer III

Location: Mansfield, MA

Duration: 6+ months

Summary Description:

• The Sr. Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
• The individual will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.
• The individual will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
• This person will support processes in base business and supervise, lead and mentor other engineers and technicians.

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 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 nonconformances, 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 with 8+ years of experience, master’s degree with 5+ years of experience, Doctoral degree with 3+ 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.