- Assist in the identification of sourcing the project scope and identification of in-scope suppliers
- Assist in qualification of identified Suppliers via project-defined Corporate Supplier Qualification Process (including closing of warrants and archiving of project documentation).
- Qualify each in-scope Supplier (to meet EU MDR via project-defined Supplier Qualification Process) and associated deliverables.
- Client requests, receives reviews, accept/reject supplier documentation until fulfillment of EU MDR requirements are met and meet process requirements.
- Implement, communicate, execute, receive, review, track, report, and archive all documentation as objective evidence as requested for purpose of compliance to EU MDR, Corporate Procedures, 21 CFR Part and 21 CFR Part
- Ensure that suppliers are EU MDR compliant via objective evidence/documentation gathered over the course of the project using Client supplier qualification process such as SPPA/PPAP
- 8- 10 years' experience as a supplier quality engineer in the medical device industry
- Experience in process validations: creating, reviewing, and approving protocols and reports, and execution of protocols.
- Must have strong skill set or evidence of ability to work without supervision yet meet project milestone dates/deliverables.
- Experience to include all components of production and process controls including, IQ, OQ, PQ, PPQ, manufacturing equipment software (CSV), and TMV/MSA.
- Experience in pFMEA, manufacturing process flows, control plans, and quality records Nice to Have Requirements
- UDI and medical device labelling/marking, quality system remediation, and ability to positively interfacing with the company's suppliers.
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Quality Engineer
Found in: Appcast US C2 - 4 days ago
Eliassen Group Marlborough, United StatesQuality Engineer, R&D, Medical Device · BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION · Our client is a privately held medical device company based in Massachusetts who innovates in the area of arterial fibrillation. Their focus is dedicated to advancing innovative treatment ...
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Quality Engineer
Found in: Lensa US 4 C2 - 5 days ago
Eliassen Group Marlborough, United StatesQuality Engineer, R&D, Medical Device · BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION · Our client is a privately held medical device company based in Massachusetts who innovates in the area of arterial fibrillation. Their focus is dedicated to advancing innovative treatme ...
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Quality Engineer
Found in: Appcast US C2 - 4 days ago
Cognex Corporation Southborough, United StatesAbout us- Cognex is the largest, most successful and recognized global player in industrial machine vision We are a financially strong, international company with no debt and have been in business for over 40 years. Using advanced optics, image sensors and artificial intelligence ...
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Quality Engineer
Found in: Lensa US 4 C2 - 2 days ago
Cognex Southborough, United StatesAbout us- Cognex is the largest, most successful and recognized global player in industrial machine vision We are a financially strong, international company with no debt and have been in business for over 40 years. Using advanced optics, image sensors and artificial intelligence ...
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Quality Engineer
Found in: Lensa US 4 C2 - 10 hours ago
Cognex Southborough, United StatesAbout us- Cognex is the largest, most successful and recognized global player in industrial machine vision We are a financially strong, international company with no debt and have been in business for over 40 years. Using advanced optics, image sensors and artificial intelligence ...
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Quality Engineer
Found in: Lensa US 4 C2 - 2 days ago
Cognex Southborough, United StatesJob DescriptionAbout us- Cognex is the largest, most successful and recognized global player in industrial machine vision We are a financially strong, international company with no debt and have been in business for over 40 years. Using advanced optics, image sensors and artifici ...
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Quality Engineer I
Found in: Lensa US 4 C2 - 2 days ago
Repligen Marlborough, United StatesFamiliar with ISO 17025 calibration regulatory requirements. - Work with Service, Manufacturing, Product Management, R&D, and Planning in support of Service Depot related activities. Effective written and oral communication required with cross functi Quality Engineer, Engineer, O ...
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Quality Engineer
Found in: Appcast US C2 - 1 day ago
Trelleborg Sealing Solutions Northborough, United StatesResponsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control o ...
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Quality Engineer
Found in: Lensa US 4 C2 - 2 days ago
Trelleborg Sealing Solutions Northborough, United StatesResponsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control o ...
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Quality Engineer
Found in: Lensa US 4 C2 - 2 days ago
Trelleborg Northborough, United StatesQuality Engineer Expectations:Supports internal audit program as necessary. · Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines c ...
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Quality Engineer
Found in: Lensa US 4 C2 - 2 days ago
Trelleborg Sealing Solutions Northborough, United StatesResponsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control o ...
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Senior Quality Engineer
Found in: Appcast US C2 - 4 days ago
Full Spectrum Southborough, United StatesAbout Us: Full Spectrum (FS) is a leading engineering services company dedicated to delivering high-quality products and services that meet and exceed customer expectations. We are currently seeking a skilled and proactive Senior Quality Engineer to join our dynamic team and cont ...
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Senior Quality Engineer
Found in: Lensa US 4 C2 - 2 days ago
Full Spectrum Services Southborough, United StatesAbout Us: Full Spectrum (FS) is a leading engineering services company dedicated to delivering high-quality products and services that meet and exceed customer expectations. We are currently seeking a skilled and proactive Senior Quality Engineer to join our dynamic team and cont ...
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Senior Quality Engineer
Found in: Lensa US 4 C2 - 2 days ago
Full Spectrum Services Southborough, United StatesAbout Us: Full Spectrum (FS) is a leading engineering services company dedicated to delivering high-quality products and services that meet and exceed customer expectations. We are currently seeking a skilled and proactive Senior Quality Engineer to join our dynamic team and cont ...
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Principal Supplier Quality Engineer, SFMD
Found in: Lensa US 4 C2 - 6 days ago
Boston Scientific Marlborough, United StatesRecruiter: Spencer Gregory HalePrincipal Supplier Quality Engineer, SFMDAbout the role:The Principal Supplier Quality Engineer will play an integral part in leading the performance improvement of Sourced Finished Medical Device (SFMD) suppliers to consistently meet Boston Scienti ...
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Principal Supplier Quality Engineer, SFMD
Found in: Lensa US 4 C2 - 3 days ago
Boston Scientific Marlborough, United StatesRecruiter: Spencer Gregory HalePrincipal Supplier Quality Engineer, SFMDAbout the role:The Principal Supplier Quality Engineer will play an integral part in leading the performance improvement of Sourced Finished Medical Device (SFMD) suppliers to consistently meet Boston Scienti ...
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Principal Supplier Quality Engineer, SFMD
Found in: Talent US C2 - 6 days ago
Boston Scientific Marlborough, United StatesRecruiter: Spencer Gregory Hale · Principal Supplier Quality Engineer, SFMD · About the role: · The Principal Supplier Quality Engineer will play an integral part in leading the performance improvement of Sourced Finished Medical Device (SFMD) suppliers to consistently meet Bosto ...
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Quality Engineer
Found in: Lensa US 4 C2 - 6 days ago
Sofregen Inc. Framingham, United StatesSofregen Medical is an emerging medical device company founded in 2014. Sofregen Medical is focused on leveraging the silk protein as a biomaterial for medical applications. Our mission is to provide our patients with a fresh start, restore confidence, and improve their quality o ...
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Quality Engineer II
Found in: Lensa US 4 C2 - 6 days ago
Laborie Medical Technologies Corp Westborough, United StatesWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters its what fuels our motivation and contributes to our success. If youre ready to make a positive impact in the lives of patients across the globe, wed like to me ...
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Quality Engineer II
Found in: Lensa US 4 C2 - 5 days ago
NEO Tech Westborough, United StatesJob DetailsJob LocationWestborough 0NK54 - Westborough, MAJob CategoryQA - Quality ControlDescriptionSummary:The Quality Engineer is responsible for providing experienced quality assurance to support production, internal and external customers, interacting with other departments, ...
Supplier Quality Engineer - Marlborough, United States - CERES Group
Description
Supplier Quality EngineerMarlborough, MA
Long Term Contract
Supplier Quality Engineer is needed to assist our client with their EU MDR initiative. The SQE should be capable of ensuring Client's Suppliers are compliant with both EU MDR and Client's process/deliverables.
The SQE will assess and qualify each Supplier, via objective evidence, that the Supplier's processes consistently produce a result or product that meets EU MDR and any other specifications identified during the project.
Duties / Expectations of Role#J-18808-Ljbffr
