Integrated Resources, Inc

1 week ago

mansfield, United States Integrated Resources, Inc ( IRI ) Full time

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.

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