Jobs
>
Bedford

    Senior Supplier Quality Engineer - Bedford, United States - InfraredX, Inc.

    InfraredX, Inc.
    InfraredX, Inc. Bedford, United States

    1 month ago

    Show more Collapse job
    Default job background
    Description

    Job Description

    Job DescriptionResponsible for ensuring that Infraredx's suppliers provide high quality materials and/or services that conform to the needs of Infraredx product quality and regulatory requirements. Key team member providing expertise on the capability of our suppliers, in establishing and maintaining the technical activities of our suppliers, and ensuring they meet business needs.


    Key Responsibilities:

    • Utilize risk-based approach in the classification and management of Infraredx suppliers.
    • Provide daily support for supplier issues arising at incoming inspection or on manufacturing floor.
    • Interface with suppliers to obtain quality data and resolve quality issues. Resolution of quality issues to include responsibility of supplier non-conformances, corrective action requests, and CAPA.
    • Participate in qualification of new suppliers, including supplier selection and approval.
    • Responsible for coordination of initial component quality requirements including first article inspection, process qualification, and assisting in supplier validation activities such as writing/approving protocols.
    • Responsible for maintaining the Approved Supplier List.
    • Provide insight regarding supplier capabilities for new and existing products, in collaboration with manufacturing, engineering, R&D, and marketing.
    • Conducts external supplier audits, as assigned, to ensure QMS compliance.
    • Maintains supplier quality records in accordance with FDA/GMP and EU MDR requirements.
    • Coordinate review of supplier change requests with cross-functional team, including evaluation of change, implementation planning, and approval.
    • Assist with supplier quarterly evaluation activities (Supplier Performance Scorecard).
    • Ability to identify under-performing suppliers and work to improve them or reduce defect occurrence rates, initiating transfer activities to alternative suppliers when necessary.
    • Consolidation of supply base through identification of redundant capabilities and initiating/supporting manufacturing or service transfers as needed.
    • Initiate and drive process/yield improvement projects where possible.
    • Develop and support requirements and activities for "dock-to-stock" program.
    • Acts as a team member in supporting quality disciplines, decisions, and practices.


    Requirements:

    • Bachelor of Science degree in a technical discipline.
    • 5-7+ years of quality engineering in life sciences industry, supplier quality experience strongly preferred.
    • Proven track record with supplier selection, approval, and management.
    • Strong written/verbal communication skills and demonstrated use of quality tools/methodologies.
    • Working knowledge of FDA/QSR, ISO, EU MDR standards, process validation, product design control, CAPA, and FMEA methodologies.
    • Proficient with Microsoft Office applications, and willingness to learn Infraredx ERP and PLM systems.
    • Certified Internal Auditor and/or experience performing Internal Audits strongly preferred.
    • Current ASQ and/or six sigma certifications preferred.


    PI91a7d343b

    We have other current jobs related to this field that you can find below

  • Lexington Medical, Inc.

    Manufacturing Quality Engineer

    3 days ago

    Lexington Medical, Inc. Bedford, United States

    Lexington Medical is a medical device manufacturer in the Boston area that produces minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has allowed us to be agile and responsive to the stapling market and has yielded 3x revenue grow ...

  • Berkshire Grey

    Senior Quality Engineer

    1 week ago

    Berkshire Grey Bedford, United States

    A Senior Quality Engineer is expected to: · Serve as the customer quality advocate on assigned program team. · Ensure that critical product characteristics (form, fit, function, safety) are identified on engineering specifications for design qualification and process control. ...

  • Entegris

    Senior Quality Engineer

    2 weeks ago

    Entegris Bedford, United States

    Company Overview and Values: · Why work at Entegris? · Lead. Inspire. Innovate. Define Your Future. · Not everyone who works for a global company shares the same background, experiences and perspectives. We leverage the differences of our employees to bring new ideas to the ta ...

  • Servomex

    Quality Engineer

    1 week ago

    Servomex Woburn, United States

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA. · The successful candidate will work closely with our manufacturing teams at our U ...

  • Randstad

    Quality Engineer

    3 weeks ago

    Randstad North Billerica, United States

    Job Summary: · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collabora ...

  • Redbock - an NES Fircroft company

    Supplier Quality Engineer

    3 days ago

    Redbock - an NES Fircroft company Billerica, United States

    Sr. Supplier Quality Engineer (Through end of Jan 2025 with plans for extension // Billerica, MA): · Top 3 Technical Skills: · Execution of Production Parts Approval Process (PPAP) · Exposure to range of supplier types, such as PCBA, sheet metal, and injection molding, will be pr ...

  • Lexington Medical, Inc.

    Quality Engineer

    2 weeks ago

    Lexington Medical, Inc. Bedford, United States

    Lexington Medical is a medical device manufacturer in the greater Boston area that produces minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has allowed us to be agile and responsive to the stapling market and has yielded 3x reve ...

  • Spectrum Industries

    Quality Engineer

    3 weeks ago

    Spectrum Industries Cambridge, United States

    Digital transformation. Sustainability. Peacekeeping. Exciting tasks that we at Diehl, in our five subgroups Metall, Controls, Defence, Aviation, and Metering, and our over employees are working on with high pressure. Discover fascinating technologies and apply now. In a family-o ...

  • Werfen

    Senior Quality Engineer I

    1 day ago

    Werfen Bedford, United States

    Overview: · Werfen · Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Origin ...

  • Werfen

    Senior Quality Engineer I

    2 weeks ago

    Werfen Bedford, United States

    Overview · Werfen · Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Origina ...

  • InfraredX, Inc.

    Principal Supplier Quality Engineer

    1 week ago

    InfraredX, Inc. Bedford, United States

    Job Description · Job DescriptionResponsible for ensuring that Infraredx's suppliers provide high quality materials and/or services that conform to the needs of Infraredx product quality and regulatory requirements. Key team member providing expertise on the capability of our sup ...

  • InfraredX, Inc.

    Senior Supplier Quality Engineer

    6 days ago

    InfraredX, Inc. Bedford, United States

    Job Description · Job DescriptionResponsible for ensuring that Infraredx's suppliers provide high quality materials and/or services that conform to the needs of Infraredx product quality and regulatory requirements. Key team member providing expertise on the capability of our sup ...

  • Ampcus

    Quality Assurance Engineer II

    2 weeks ago

    Ampcus Bedford, United States

    Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products. · Job Duties: · Works closely with cross-functional teams, including product design, product management, and production, to identify and ...

  • Dassault Systemes

    Quality Assurance Automation Engineer

    2 weeks ago

    Dassault Systemes Waltham, United States

    Envie de rejoindre et de grandir au sein d'une equipe ayant la passion du changement et de l'innovation ? Motive(e) a l'idee de collaborer a des projets au plus pres des enjeux de nos clients ? · Pour accompagner la forte croissance de notre groupe, nous recrutons un(e) Supply Ch ...

  • Priority Search

    Quality Engineer

    2 days ago

    Priority Search Waltham, United States

    We are working on an exciting opportunity to join this Boston area commercial medical device combination product company. Our client uses its proprietary technology platform to support a broad pipeline of products, with an initial focus on pancreatic insufficiency which results i ...

  • Servomex

    Quality Engineer

    1 week ago

    Servomex Woburn, United States

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA. · The successful candidate will work closely with our manufacturing teams at our ...

  • Entegris

    Senior Quality Engineer

    3 weeks ago

    Entegris Billerica, United States

    Job Title: · Senior Quality Engineer (Chemical Engineering) · Job Description: · Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue that mission. · The Role: · Our facility in ...

  • Entegee

    Sr Quality Engineer

    3 days ago

    Entegee Billerica, United States

    Job Description · Job DescriptionJob Summary: Seeking a Senior Quality Engineer with expertise in Process Validation, Computer Software Validation, and Equipment Qualification to ensure the highest standards in the manufacturing of medical devices. · Job Requirements: · Expertise ...

  • Brooks Automation

    Quality Engineer

    1 week ago

    Brooks Automation Chelmsford, United States Full time

    Description · The Supplier Quality Engineer is responsible for the overall supplier quality of specific suppliers, contract manufacturers and material commodities within Brooks. This position spans both technical responsibilities and supplier quality management with a focus on m ...

  • Servomex

    Senior Quality Engineer

    5 days ago

    Servomex Woburn, United States

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Senior Quality Engineer to join our high performing team at our facility in Woburn, MA. The successful candidate will work closely with our Manufacturing and E ...