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Job Requirements of Sr. Quality Specialist:
-
Employment Type:
Contractor
-
Location:
Mansfield, MA (Onsite)
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Sr. Quality Specialist
Careers Integrated Resources Inc
Mansfield, MA (Onsite)
Contractor
Title: Sr. Quality Specialist
Location: Mansfield, MA
Duration: 6 Months
Pay Rate: $44/hr to 54/hr.
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.
Location: Mansfield, MA
Duration: 6 Months
Pay Rate: $44/hr to 54/hr.
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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