Jobs
>
Trumbull

    Supplier Quality Engineer - Trumbull, United States - Cooper Companies

    Cooper Companies
    Cooper Companies Trumbull, United States

    3 weeks ago

    Default job background
    Description
    Job Description

    About CooperSurgical


    CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

    CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families.

    We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

    CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO).

    CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians.

    More information can be found at

    Responsibilities


    Lead PPAP Activities and train SQE's and other organizations on PPAPLead and conduct IQ, OQ, PQ and other validation activitiesSupplier Development activitiesRisk AssessmentsFull knowledge of and understanding of PPAP, IQ, OQ, PQ and validation activitiesLead and determine correct PPAP levels with the ability to write protocols of IQ, OQ, PQ and PPAP checklist and warrants.

    Full knowledge, application and management of Supplier Quality sustaining and strategic activitiesKnowledge and full understanding of the medical device requirements (e.g., FDA QSR, ISO 13485, EU MDR, CMDCAS and etc.).Support transfer projects and Supplier localization projects.

    Other possible activities are those listed below.


    Facilitates the supplier compliance program (Site audit, drive improvement in supplier performance, supplier development, supplier selection and qualification).Acts as a quality assurance consultant in the development and implementation of quality systems in compliance with FDA QSR, ISO 13485, MDD and CMDCAS and other relevant requirements at partner suppliers/vendors in order to support operations and development engineering.

    Works with Value Streams once Engineering and Quality Engineering; confirm there is a Supplier related improvement opportunity or Non-Conforming Material Reports (NCMRs).


    • Supports development and implementation of supplier quality program by doing the following:
    a. Support supplier on-going monitoring and re-evaluation process.

    b. Manage Supplier SCAR / CAPA / NCR and periodically provide metrics/report to Management Review Process.

    c. Create/ Maintain supplier quality agreements.

    d. Support all Procurement supplier Projects.

    e. Support all new Product Development that is intended for production at suppliers.

    f. Support all business continuity projects at suppliers.

    g. Update SOPs and Forms related to supplier management process as neededSupports internal and external QMS audits. And works as a key player in the audit's backup rooms or inspection rooms.

    Files and maintains Supplier related documentation as per QMS.Perform supplier audits, conduct supplier site visits as needed to identify systemic gaps in performance expectations at suppliers and implement mitigating processes at Cooper sites, as needed.

    Works and leads collaborative activities with Quality Engineers, Inspectors, Value Streams as well as Purchasing, Engineering teams.
    When required, submits Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs. And reviews Supplier responses for appropriate root cause analysis and Corrective Actions to prevent re-occurrence of failure modes.
    Performs additional assignments as required by management.
    Create a critical review of supplier strategies and segmentation strategies.20% to 50% Travel

    Qualifications

    Education:
    Bachelor's degree / Master's degreeBlack Belt a plusCertified Quality Engineer, Certified Reliability Engineer a plus

    Experience:

    Minimum 7 to 10 years of related experience in PPAP and IQ, OQ, PQ validations.5 to 7 years in regulated quality environment.

    Evaluate and provide input into Risk Management processes both internal and externalWorking knowledge of Lean Principles, Six Sigma and their applicationPerform and drive Supplier Development activities and improvements.

    With previous experience negotiating with Suppliers.

    Certified Quality Engineer, Black Belt or equivalent certificationsMaster's degree or equivalent work experiencesExecution and driver of results as a team lead and as an active participantServes as a leader and a coach in in Supplier Management, Quality Tools, analytic evaluations, risk management, Dfx, and other engineering activities.

    Able to define, implement and manage a nonconformance system.

    Fully understand 8-D process and have the ability .Full understanding and application of FDA QSR, ISO 13485, and other applicable regulationsWorking knowledge of Dfx, Risk Management, and Data AnalysisWorking knowledge and ability to properly problem solve utilizing the appropriate Quality ToolsEffectively evaluate drawings and provide improvements and recommendations if necessary (e.g., dimensions, tolerances, notes, and etc.)Understanding, knowledge and application of relevant processes and the various cost drivers per market, commodity or segment.

    Previous experience in supply chain, auditing, verification, and validation, GD&T.Previous experience with Change Control Systems and Design Control.
    Excellent verbal and written communication skills and strong organizational skillsAdvance level of English speaking and writing. Traveling experience is a plus.
    Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems.
    Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records.

    As an employee of CooperSurgical, you'll receive an outstanding total compensation plan.

    As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

    Please visit us at to learn more about CooperSurgical and the benefits of becoming a member of our team.


    To all agencies:
    Please, no phone calls or emails to any employee of CooperSurgical about this opening.

    All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place.

    In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.


    We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status.

    We are proud to be an equal opportunity workplace.
    #J-18808-Ljbffr


  • CooperSurgical Trumbull, United States

    About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of d Quality Engineer, Engineer, H ...


  • Cooper Companies Trumbull, United States

    Job Description · About CooperSurgical · CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering ...

  • Lockheed Martin Corporation

    Quality Engineer

    2 weeks ago


    Lockheed Martin Corporation Stratford, United States

    Job DescriptionThe WorkQuality Engineer (QE) position supporting the Advanced Inspection Technology Group (AITG) located at RMS Sikorsky in Stratford, CT. This position will report to the AITG Quality Associate Manager. The QE will assist with the implementation and execution of ...

  • Lockheed Martin Corporation

    Quality Engineer

    3 weeks ago


    Lockheed Martin Corporation Stratford, United States

    Job ID: 666991BR Date posted: May. 16, 2024Description:The WorkQuality Engineer (QE) position supporting the Advanced Inspection Technology Group (AITG) located at RMS Sikorsky in Stratford, CT. This position will report to the AITG Quality Associate Manager. The QE will assist w ...

  • Nexus Solutions

    Quality Engineer

    1 week ago


    Nexus Solutions Lake Ronkonkoma, United States

    Job ID: R · Your contribution to our joint success · As a Quality Engineer (m/f/*) at our location in Hilden, you have the opportunity to use your knowledge in a targeted manner to advance our joint success. Your responsibilities include: · Quality-related support of production ...


  • The Cooper Companies Trumbull, United States

    About CooperSurgical · CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assist ...


  • CooperSurgical Trumbull, United States

    CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative Quality Engineer, Principal, E ...


  • CooperSurgical Trumbull, United States

    About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of d Quality Engineer, Design, Qua ...


  • Cooper Companies Trumbull, United States

    Job Description · About CooperSurgical · CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of deliverin ...


  • Cooper Companies Trumbull, United States

    Job Description · About CooperSurgical · CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of deliverin ...


  • Cooper Companies Trumbull, United States

    Job Description · About CooperSurgical · CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering ...

  • Luxium Solutions, LLC

    Quality Engineer

    2 weeks ago


    Luxium Solutions, LLC Milford, United States

    Job Description · Job DescriptionLuxium Solutions is strengthening the health, security, and future of the world by providing leading edge innovative materials and solutions. The team is passionately committed to customer success with high performance materials and inspired solut ...

  • Lockheed Martin Corporation

    Quality Engineer

    1 week ago


    Lockheed Martin Corporation Stratford, United States

    The Work. Quality Engineer (QE) position supporting the Advanced Inspection Technology Group (AITG) located at RMS Sikorsky in Stratford, CT. This position will report to the AITG Quality Associate Manager. The QE will assist with the implementation Quality Engineer, Associate Ma ...

  • Lockheed Martin Corporation

    Quality Engineer

    2 weeks ago


    Lockheed Martin Corporation Stratford, United States

    JOB ID: · 666991BR · Date posted: · May. 16, 2024 · Description: · The Work · Quality Engineer (QE) position supporting the Advanced Inspection Technology Group (AITG) located at RMS Sikorsky in Stratford, CT. This position will report to the AITG Quality Associate Manager. T ...

  • Lockheed Martin Corporation

    Quality Engineer

    1 week ago


    Lockheed Martin Corporation Stratford, United States

    Job ID: 667426BR Date posted: May. 28, 2024Description:The WorkQuality Engineer (QE) position supporting the Advanced Inspection Technology Group (AITG) located at RMS Sikorsky in Stratford, CT. This position will report to the AITG Quality Associate Manager. The QE will assist w ...

  • Lockheed Martin Corporation

    Quality Engineer

    1 week ago


    Lockheed Martin Corporation Stratford, United States

    Job DescriptionThe WorkQuality Engineer (QE) position supporting the Advanced Inspection Technology Group (AITG) located at RMS Sikorsky in Stratford, CT. This position will report to the AITG Quality Associate Manager. The QE will assist with the implementation and execution of ...

  • Katalyst HealthCares & Life Sciences

    Quality Engineer

    1 week ago


    Katalyst HealthCares & Life Sciences North Haven, United States

    Responsibilities: Contribute to continuous improvements in overall product cost and quality. · Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration. · Collaborate with Quality Engineering to provide manufa ...

  • Lockheed Martin Corporation

    Quality Engineer

    1 week ago


    Lockheed Martin Corporation Stratford, United States

    Job Description · The Work · Quality Engineer (QE) position supporting the Advanced Inspection Technology Group (AITG) located at RMS Sikorsky in Stratford, CT. This position will report to the AITG Quality Associate Manager. The QE will assist with the implementation and execu ...

  • Lockheed Martin Corporation

    Quality Engineer

    2 weeks ago


    Lockheed Martin Corporation Stratford, United States

    Job Description · The Work · Quality Engineer (QE) position supporting the Advanced Inspection Technology Group (AITG) located at RMS Sikorsky in Stratford, CT. This position will report to the AITG Quality Associate Manager. The QE will assist with the implementation and execu ...

  • LTTS

    Quality Engineer

    2 weeks ago


    LTTS North Haven, United States

    Job Description & Skill Requirement: · • Contribute to continuous improvements in overall product cost and quality. · • Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration. · • Collaborate with Quality Engine ...