Principal Supplier Quality Engineer, SFMD

4 weeks ago

Marlborough, United States Boston Scientific Gruppe Full time

Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert:

Create Alert Principal Supplier Quality Engineer, SFMD

Onsite Location(s):

Marlborough, MA, US, 01752

Recruiter:

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 Boston Scientific’s requirements. This individual will demonstrate a primary commitment to patient safety and will be responsible for collaborating with suppliers and cross-functional internal teams to ensure product quality meets our customer’s expectations. Your responsibilities will include: Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Supports the evaluation of proposed changes at suppliers. Communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Review and approve supplier corrective action plans and verification of effectiveness documentation. Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. New Product Development: Lead the execution of SFMD Quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers and innovative medical devices. Generate/review quality plans, agreements, product specifications, component qualifications, and process validations. Assess readiness at supplier and support implementation. Quality System and Culture Champion: Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Leads cross-divisional and cross-functional projects that deliver improvements to quality systems and processes. Provides mentorship and coaching to junior engineers; identifies others’ challenges and helps them reach higher work standards. Champions 100% compliance to company policies and SOP’s. BS degree in engineering or technical field with minimum of 8 years of relevant experience. Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry. Experience in process validation, design controls, risk management, and CAPA. Communicates effectively and concisely packages up information to deliver key points; appropriately scales communication style and depth according to the audience. Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors. Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing. Ability to work independently and collaborate with project teams; organized and self-driven. ISO 13485 lead auditor of quality systems experience. Strong knowledge of FDA 21 CFR 820 and EU MDR. Lean Six Sigma and equivalent certifications. Experience in global supplier management and supplier quality engineering role. Requisition ID:

580785 Among other requirements, Boston Scientific maintains specific

prohibited substance

test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a

prohibited substance

test as a requirement. The goal of the

prohibited substance

testing is to increase workplace safety in compliance with the applicable law.

Nearest Major Market:

Boston Job Segment:

Medical Device, Medical Device Engineer, Quality Engineer, Lean Six Sigma, Testing, Healthcare, Engineering, Management, Technology

#J-18808-Ljbffr

  • Principal Supplier Quality Engineer, SFMD

    1 month ago

    Marlborough, United States Boston Scientific Full time

    Recruiter: 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 Boston Scientific’s requirements. This individual will demonstrate a primary commitment...

  • Principal Supplier Quality Engineer, SFMD

    4 weeks ago

    Marlborough, United States Boston Scientific Full time

    Recruiter: 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 Boston Scientific’s requirements. This individual will demonstrate a primary commitment...

  • Principal Supplier Quality Engineer

    1 week ago

    Marlborough, United States Boston Scientific Full time

    Recruiter: 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 Boston Scientific’s requirements. This individual will demonstrate a primary commitment...

  • Supplier Engineer

    7 days ago

    Marlborough, United States US Tech Solutions Full time

    Duration: 12 Months Contract (Possible Extension) About The Role: The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12-month contract position is part of the Sourced Finished Medical...

  • Supplier Engineer

    1 week ago

    Marlborough, United States US Tech Solutions Full time

    Duration: 12 Months Contract (Possible Extension)About The Role:The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12-month contract position is part of the Sourced Finished Medical...

  • Engineer - Manufacturing Engineer III

    1 week ago

    Marlborough, United States Talent Software Services Full time

    Job Description: Hybrid bout The Role: The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12 month contract position is part of the Sourced Finished Medical Device team and entails...

  • Manufacturing Engineer

    2 weeks ago

    Marlborough, United States Insight Global Full time

    Title: Manufacturing EngineerPay rate: $43-50/hrLocation: Marlborough MA (hybrid schedule)About The Role:The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This position is part of the Sourced...

  • Manufacturing Engineer

    2 weeks ago

    Marlborough, United States Insight Global Full time

    Title: Manufacturing EngineerPay rate: $43-50/hrLocation: Marlborough MA (hybrid schedule)About The Role:The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This position is part of the Sourced...

  • Manufacturing Engineer

    1 week ago

    Marlborough, United States Insight Global Full time

    Title: Manufacturing Engineer Pay rate: $43-50/hr Location: Marlborough MA (hybrid schedule) About The Role: The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This position is part of the...

  • Manufacturing Engineer

    2 weeks ago

    Marlborough, Massachusetts, United States Talent Software Services, Inc. Full time

    Manufacturing Engineer - SeniorJob Summary: Talent Software Services is in search of a Manufacturing Engineer - Senior for a contract position in Marlborough, MA. The opportunity will be one year with a strong chance for a long-term extension.Position Summary: The Manufacturing Engineer Senior, External Products will design, develop, and validate...

  • Manufacturing engineer III

    4 weeks ago

    Marlborough, United States Insight Global Full time

    Manufacturing Engineer III The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12 month contract position is part of the Sourced Finished Medical Device team and entails driving...

  • Manufacturing engineer III

    4 weeks ago

    Marlborough, United States Insight Global Full time

    Manufacturing Engineer III The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12 month contract position is part of the Sourced Finished Medical Device team and entails driving...

  • Manufacturing engineer III

    4 weeks ago

    Marlborough, United States Insight Global Full time

    Manufacturing Engineer IIIThe Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12 month contract position is part of the Sourced Finished Medical Device team and entails driving...

  • Manufacturing engineer III

    4 weeks ago

    Marlborough, United States Insight Global Full time

    Manufacturing Engineer IIIThe Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12 month contract position is part of the Sourced Finished Medical Device team and entails driving...

  • Manufacturing engineer III

    4 weeks ago

    Marlborough, United States Insight Global Full time

    Manufacturing Engineer IIIThe Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12 month contract position is part of the Sourced Finished Medical Device team and entails driving...

  • Manufacturing engineer III

    4 weeks ago

    Marlborough, United States Insight Global Full time

    Manufacturing Engineer IIIThe Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12 month contract position is part of the Sourced Finished Medical Device team and entails driving...

  • Hardware/Supplier Quality Assurance Professional

    4 weeks ago

    Marlborough, United States RTX Full time

    Date Posted:2024-05-08Country:United States of AmericaLocation:MA803: Marlborough, MA Building 3 1001 Boston Post Road Building 3, Marlborough, MA, 01752 USAPosition Role Type:HybridCollins Connected Aviation Solutions (CAS) organization ensures that known good parts and services are received from the supply chain. We work collaboratively with our internal...

  • Hardware/Supplier Quality Assurance Professional

    4 weeks ago

    Marlborough, United States Raytheon Technologies Full time

    Date Posted:2024-05-08Country:United States of AmericaLocation:MA803: Marlborough, MA Building 3 1001 Boston Post Road Building 3, Marlborough, MA, 01752 USAPosition Role Type:HybridCollins Connected Aviation Solutions (CAS) organization ensures that known good parts and services are received from the supply chain. We work collaboratively with our internal...

  • Hardware/Supplier Quality Assurance Professional

    3 weeks ago

    Marlborough, United States RTX Full time

    Date Posted: 2024-05-08 Country: United States of America Location: MA803: Marlborough, MA Building 3 1001 Boston Post Road Building 3, Marlborough, MA, 01752 USA Position Role Type: Hybrid Collins Connected Aviation Solutions (CAS) organization ensures that known good parts and services are received from the supply chain. We work collaboratively with our...

  • Hardware/Supplier Quality Assurance Professional

    2 weeks ago

    Marlborough, United States Raytheon Technologies Full time

    Date Posted: 2024-05-08 Country: United States of America Location: MA803: Marlborough, MA Building 3 1001 Boston Post Road Building 3, Marlborough, MA, 01752 USA Position Role Type: Hybrid Collins Connected Aviation Solutions (CAS) organization ensures that known good parts and services are received from the supply chain. We work collaboratively with our...