Quality - Investigator - Quality Assurance

4 weeks ago


Westborough, United States TalentBurst, an Inc 5000 company Full time

What you’ll do

• Execute the triage, investigation, and closure of product quality complaints.

• Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.

• Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management. Support with tracking major issues and related corrective actions.

• Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.

• Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers


Who you are

• Bachelor’s degree required; additional training/education preferred through ASQ (or relevant society) and/or Master’s level program

• Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required

• Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)

• Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance

• Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints


  • Quality Investigator

    1 month ago


    Westborough, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: Interface with customers in various forms of communications including regional forums and specific customer touchpoints, as requested by various teams in the field. Provide data and analysis for customer specific meetings. Proactive Failure Mode Trending to identify emerging issues across various Westborough product groups and...


  • Westborough, United States LanceSoft Full time

    Job Description: Title: Quality Assurance Engineer Location: Westborough, MA 01581 Shift: 1st Shift Duration: 09 months (Possible Extension) The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the...

  • Quality Assurance

    7 days ago


    Westborough, United States Abacus Full time

    Job Description: The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices...


  • Westborough, United States Abacus Serivice Corporation Full time

    Job DescriptionJob DescriptionJob Description:The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality...


  • Westborough, United States TalentBurst, Inc. Full time

    Quality Assurance EngineerMedical Device ( Manufacturing)Westborough, MA9 month contract to startJob Description: The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices.The Quality Assurance Engineer is responsible for the development, implementation,...


  • Westborough, United States Kelly Science, Engineering, Technology & Telecom Full time

    Manufacturing Quality Engineer Location: Onsite - Westborough, Massachusetts (01581)Type: Contract - (NO C2C OR THIRD PARTY)Pay Rate – Negotiable depending on DIRECT-related experienceWork Authorization - Must be able to work in the U.S. with approved authorization status as a citizen or lawful permanent resident of the United States. Visa Status is not...


  • Westborough, United States Kelly Science, Engineering, Technology & Telecom Full time

    Manufacturing Quality Engineer Location: Onsite - Westborough, Massachusetts (01581)Type: Contract - (NO C2C OR THIRD PARTY)Pay Rate – Negotiable depending on DIRECT-related experienceWork Authorization - Must be able to work in the U.S. with approved authorization status as a citizen or lawful permanent resident of the United States. Visa Status is not...


  • Westborough, United States Kelly Science, Engineering, Technology & Telecom Full time

    Manufacturing Quality Engineer Location: Onsite - Westborough, Massachusetts (01581)Type: Contract - (NO C2C OR THIRD PARTY)Pay Rate – Negotiable depending on DIRECT-related experienceWork Authorization - Must be able to work in the U.S. with approved authorization status as a citizen or lawful permanent resident of the United States. Visa Status is not...

  • Quality Engineer

    1 week ago


    Westborough, United States Kelly Services, Inc. Full time

    #x 9; Provide manufacturing and/or engineering process support in accordance with documented procedures and practices. Responsible for the development, implementation, improvement, and continuous reinforcement of established Quality Assurance fundame Quality Engineer, Engineer, Quality Assurance, Product Development, Technology, Staffing

  • Quality Engineer

    4 weeks ago


    Westborough, United States SUMERU INC Full time

    **Key Responsibilities**: - Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records. - Writes and reviews technical reports and investigation/CAPA memos which are communicated to...

  • Quality Engineer

    1 week ago


    Westborough, United States Kelly Science, Engineering, Technology & Telecom Full time

    Hello, my name is Daniel, and I am a recruiter with Kelly Services. One of our prominent clients is seeking a Quality Engineer in Westborough, MA.Responsibilities:Provide manufacturing and/or engineering process support in accordance with documented procedures and practices.Responsible for the development, implementation, improvement, and continuous...

  • Quality Engineer

    1 week ago


    Westborough, United States Kelly Science, Engineering, Technology & Telecom Full time

    Hello, my name is Daniel, and I am a recruiter with Kelly Services. One of our prominent clients is seeking a Quality Engineer in Westborough, MA.Responsibilities:Provide manufacturing and/or engineering process support in accordance with documented procedures and practices.Responsible for the development, implementation, improvement, and continuous...


  • Westborough, United States Talent Groups Full time

    5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries.Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FDA CFR 21 820 and ISO 13485.Familiarity with product development lifecycles,...


  • Westborough, United States Talent Groups Full time

    5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries.Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FDA CFR 21 820 and ISO 13485.Familiarity with product development lifecycles,...


  • Westborough, United States Olympus Full time

    Job DescriptionThe Senior Supplier Quality Engineer is responsible for the product-related supplier quality within a defined material segment and / or site including part approval, SCAR handling, development project support, sustaining engineering support including non-conformance handling and incoming inspection planning. Job Duties Develops quality...

  • Quality Engineer II

    2 weeks ago


    Westborough, United States Laborie Medical Technologies Corp Full time

    We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an...


  • Westborough, United States Talent Group Full time

    5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries.Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FDA CFR 21 820 and ISO 13485.Familiarity with product development lifecycles,...

  • Quality Engineer II

    5 days ago


    Westborough, United States Laborie Medical Technologies Corp Full time

    We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an...

  • Quality Manager

    4 weeks ago


    Westborough, United States Management Business Solutions Full time

    Responsibilities Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adherence to health and safety guidelines as well as legal obligations Supervise...


  • Westborough, United States Olympus Full time

    Job DescriptionThe Principal Supplier Quality Engineer is responsible for the product/service-related supplier quality within defined material segment and / or site including part approval, SCAR handling, development project support, sustaining engineering support including non-conformance handling and incoming inspection planning. They are specialized in a...