Supplier Quality Engineer/ Medical Device

3 weeks ago


Beverly, United States Connexion Systems & Engineering, Inc. Full time $85,000 - $120,000
Job DescriptionJob Description

Our client is looking for a Supplier Quality Engineer this professional will be responsible to maintain the quality system and support supplier and incoming quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices. 

ESSENTIAL FUNCTIONS: 

The incumbent may be required to perform all, or a combination of the following essential functions as determined by business necessity.
 
* Work with suppliers and the Purchasing department to address quality issues with raw materials and components
* Maintain supplier approvals and certifications
* Review supplier quality agreements
* Make use of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOE
* Solve problems using Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D
* Maintain Quality Records
* Perform Corrective Actions and Non-conformance assessments
* Perform supplier audits as well as internal audits
* Support Incoming Inspection
* Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends
* Participate in and lead continual improvement projects
* Travel up to 25% required for supplier support and audits

NON-ESSENTIAL FUNCTIONS: 
In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions.  Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

QUALIFICATIONS:
 
* Bachelor’s Degree in Industrial, Mechanical or Biomedical engineering or equivalent experience.
* Very good written and verbal communication skills.
* At least 5 years of experience working with suppliers; preferably in the medical device or other regulated industry.
* CQA or certified biomedical auditor certification helpful but not required.
* Experience with supplier audits and supplier management.
* Experience with quality management systems standards (ISO13845, ISO9001, AS9100)
* Accuracy, thoroughness, attention to detail, legibility in completing records is essential.
* Lean and 6Sigma knowledge a plus.
 

Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

  • Beverly, United States Microline Surgical Inc. Full time

    Job DescriptionJob DescriptionJOB SUMMARY: Maintain the quality system and support supplier and incoming quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices. ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following essential...

  • Quality Engineer

    2 months ago


    Beverly, United States Goddard Inc. Full time

    Join us as a Quality Engineer and play a crucial role in ensuring our products are developed in compliance with standards, regulations and engineering best practices. You will be a key member of our growing QA and V&V team, upholding the integrity and reliability of our work while making a significant impact on potentially lifesaving products.In this Role,...


  • Beverly, United States Connexion Systems & Engineering, Inc. Full time $101,000 - $145,000

    Job DescriptionJob DescriptionSenior Manufacturing Engineer Location: Beverly, MANotes:This is a very "hands-on" role SUMMARY: Plans and coordinates work to higher level project schedules; develops longer term plans under guidance; analyzes complex problems independently, coordinates cross-functional development and supplier work.  Responsible for...


  • Beverly, Massachusetts, United States Quanta Dialysis Technologies Full time

    Job OverviewPosition Title: Senior Quality Systems EngineerCompany: Quanta Dialysis Technologies Inc.Location: Remote/HybridRole Summary:The Senior Quality Systems Engineer is accountable for overseeing the Quality Management System (QMS) at Quanta Dialysis Technologies. This role encompasses supporting various compliance-related activities, including...


  • Beverly, United States Axcelis Technologies Full time

    Senior Quality Assurance Engineer Want to discover just how far your intellectual curiosity can take you? You're in the right place. For more than four decades, Axcelis Technologies has been at the forefront of innovation in semiconductor manufacturing technology. Chipmakers around the globe rely on our tools and process expertise to deliver the...


  • Beverly, Massachusetts, United States Quanta Dialysis Technologies Full time

    Job OverviewPosition Title: Senior Quality Systems EngineerCompany: Quanta Dialysis Technologies Inc.Location: Remote/HybridRole Summary:The Senior Quality Systems Engineer is accountable for the upkeep of the Quality Management System (QMS) at Quanta Dialysis Technologies. This role encompasses all activities related to Quality compliance, including but not...


  • Beverly, Massachusetts, United States Quanta Dialysis Technologies Full time

    Job OverviewPosition Title: Senior Quality Systems EngineerCompany: Quanta Dialysis Technologies Inc.Location: Remote/HybridRole Summary:The Senior Quality Systems Engineer is accountable for overseeing the Quality Management System (QMS) at Quanta Dialysis Technologies. This role entails ensuring compliance with various regulatory standards, including...


  • Beverly, United States Quanta Dialysis Technologies Full time

    Job DescriptionJob DescriptionJob Title: Sr. Quality Systems EngineerCompany Name: Quanta Dialysis Technologies Inc.Job Location: Beverly, MAJob Description:Responsible for maintaining the Quality Management System for Quanta Dialysis Technology and support with all Quality compliance related activities, including but not limited to, internal audits,...


  • Beverly Hills, California, United States Goddard Inc. Full time

    Join Our Team as a Quality Assurance SpecialistAs a vital member of our organization, you will contribute significantly to the assurance that our products are developed in alignment with industry standards, regulations, and engineering best practices.Your role will be essential in our expanding Quality Assurance and Verification & Validation team, ensuring...


  • Beverly, United States BioTalent Full time

    BioTalent is partnered with a medical device manufacturer focusing on next-generation technology focusing on laser and imaging tech. You will be focused on the production of class III devices while leading an existing team through QA/RA endeavors.ResponsibilitiesEnsure that all products and processes comply with applicable regulatory requirements (e.g., FDA,...


  • Beverly, United States BioTalent Full time

    BioTalent is partnered with a medical device manufacturer focusing on next-generation technology focusing on laser and imaging tech. You will be focused on the production of class III devices while leading an existing team through QA/RA endeavors.ResponsibilitiesEnsure that all products and processes comply with applicable regulatory requirements (e.g., FDA,...


  • Beverly, Massachusetts, United States BioTalent Full time

    BioTalent is collaborating with a cutting-edge medical device company specializing in advanced laser and imaging technologies. In this role, you will oversee the production of class III medical devices while guiding a dedicated team through Quality Assurance and Regulatory Affairs initiatives.Key ResponsibilitiesEnsure compliance of all products and...

  • Quality Engineer

    4 weeks ago


    Beverly, United States Michael Page Full time

    Diverse Career OpportunitiesIndustry Leader & Reputation About Our Client My client is a highly regarded company known for its commitment to quality and precision in the manufacturing industry. They specialize in producing high-performance components, particularly in the aerospace sector, where their products are trusted by leading companies. The team is...


  • Beverly, Massachusetts, United States CPI Electron Device Business Full time

    About CPI Electron Device BusinessCPI Electron Device Business is a leading global provider of electronic components and subsystems, serving the radar, defense, industrial, and scientific markets.Job DescriptionWe are seeking a highly motivated and skilled Mechanical Assembly Specialist to join our team. As a Mechanical Assembly Specialist, you will be...


  • Beverly, Massachusetts, United States Microline Surgical Inc. Full time

    Job OverviewSUMMARY: The Senior Manufacturing Engineer is responsible for planning and coordinating work aligned with advanced project timelines. This role involves developing long-term strategies under supervision, tackling intricate challenges independently, and managing cross-functional development alongside supplier collaboration. The engineer will...


  • Beverly, United States ProSearch Full time

    Our client, a leading Medical Device Manufacturer, is seeking a Director of Software Engineering. This Direct Hire position is a hands-on leadership role responsible for all aspects of software and firmware development within their organization.Responsibilities Summary:They are looking for someone to lead, mentor, and manage a team of software engineers and...


  • Beverly, United States ProSearch Full time

    Our client, a leading Medical Device Manufacturer, is seeking a Director of Software Engineering. This Direct Hire position is a hands-on leadership role responsible for all aspects of software and firmware development within their organization.Responsibilities Summary:They are looking for someone to lead, mentor, and manage a team of software engineers and...


  • Beverly, United States Microline Surgical Inc. Full time

    Job DescriptionJob DescriptionSUMMARY: Plans and coordinates work to higher level project schedules; develops longer term plans under guidance; analyzes complex problems independently, coordinates cross-functional development and supplier work. Responsible for creating, documenting, developing and implementing procedures used to assemble, process, test and...


  • Beverly Hills, California, United States Micro Tech Staffing - Stoughton Full time

    Job DescriptionJob Summary:We are seeking a highly skilled Manufacturing Process Engineer to join our team at Micro Tech Staffing - Stoughton. As a key member of our production team, you will be responsible for planning, coordinating, and executing projects to meet higher-level schedules and long-term objectives.Key Responsibilities:Project Planning and...


  • Beverly, Massachusetts, United States CPI Electron Device Business Full time

    About the RoleCPI Electron Device Business is seeking a highly skilled and experienced Director of Information Technology and Systems to lead our IT operations and drive business growth. As a key member of our leadership team, you will be responsible for developing and implementing IT strategies that align with our business objectives.Key ResponsibilitiesIT...