Principal Quality Assurance Engineer

3 days ago

Warren, Ohio, United States Cooper Companies Full time
Job Description

CooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals.

We are seeking a highly skilled Principal Quality Assurance Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest level of quality in our products and services.

Responsibilities
  • Lead and determine correct PPAP levels with the ability to write protocols of IQ, OQ, PQ, and PPAP checklists and warrants.
  • Full knowledge, application, and management of Supplier Quality sustaining and strategic activities.
  • Knowledge and full understanding of medical device requirements (e.g., FDA QSR, ISO 13485, EU MDR, CMDCAS).
  • Support transfer projects and Supplier localization projects.
  • Facilitate the supplier compliance program (site audit, drive improvement in supplier performance, supplier development, supplier selection, and qualification).
  • Act 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.
  • Work with Value Streams to confirm there is a Supplier-related improvement opportunity or Non-Conforming Material Reports (NCMRs).
  • Support the development and implementation of supplier quality programs.
  • Support internal and external QMS audits.
  • Perform supplier audits and conduct supplier site visits as needed to identify systemic gaps in performance expectations at suppliers.
  • Work collaboratively with Quality Engineers, Inspectors, Value Streams, and Purchasing, Engineering teams.
Qualifications
  • Bachelor's degree or Master's degree.
  • Black Belt a plus.
  • Certified Quality Engineer, Certified Reliability Engineer a plus.
  • Minimum 7 to 10 years of related experience in PPAP and IQ, OQ, PQ validations.
  • 5 to 7 years in regulated quality environments.
  • Evaluate and provide input into Risk Management processes both internal and external.
  • Working knowledge of Lean Principles, Six Sigma, and their application.
  • Perform and drive Supplier Development activities and improvements.
  • With previous experience negotiating with Suppliers.
  • Certified Quality Engineer, Black Belt, or equivalent certifications.
  • Master's degree or equivalent work experiences.

We offer a competitive 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 https://www.coopersurgical.com/careers to learn more about CooperSurgical and the benefits of becoming a member of our team.

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.

  • Principal Quality Engineer

    3 days ago

    Warren, Ohio, United States Cooper Companies Full time

    Job Title: Principal Quality EngineerCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. We are seeking a Principal Quality Engineer to join our team.Responsibilities:Lead and determine correct PPAP levels with the ability to write protocols of...

  • Quality Assurance Engineer

    2 days ago

    Warren, Ohio, United States Cooper Companies Full time

    Job Title: Temp Quality Engineer IICooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals.We are seeking a highly skilled Temp Quality Engineer II to join our team. As a key member of our quality team, you will be responsible for ensuring the quality...

  • Principal Software Engineer/Software Architect

    2 weeks ago

    Warren, Ohio, United States CooperSurgical Full time

    Job Title: Principal Software Engineer/Software ArchitectCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. We are seeking a highly skilled Principal Software Engineer/Software Architect to join our CSI R&D Software team.Responsibilities:Lead the...

  • Quality Assurance Engineer II

    4 days ago

    Warren, Ohio, United States Cooper Companies Full time

    About CooperSurgicalCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals.We offer a wide range of clinically relevant medical devices to women's healthcare providers, including testing and treatment options.As a wholly-owned subsidiary of...

  • Quality Assurance Nurse

    2 weeks ago

    Warren, Ohio, United States OMNI MANOR INC Full time

    Job DetailsLevelExperiencedJob LocationWindsor House at Champion - Warren, OHDescriptionAs a key member of our team, the Quality Assurance Nurse will be responsible for making and acting upon recommendations for QA activities across all departments.The successful candidate will work closely with management and inter-disciplinary teams to identify areas for...

  • Senior Design Quality Assurance Specialist

    3 weeks ago

    Warren, Ohio, United States Cooper Companies Full time

    About CooperSurgicalCooperSurgical is a leading company in the fertility and women's healthcare industry, dedicated to delivering innovative solutions that enhance the work of healthcare professionals and benefit families.We offer a wide range of clinically relevant medical devices to women's healthcare providers, including testing and treatment options.As a...

  • Quality Assurance Engineer II

    2 weeks ago

    Warren, Ohio, United States Cooper Companies Full time

    About CooperSurgicalCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. With a wide array of products and services, we strive to put time on the side of women, babies, and families at the moments that matter most.ResponsibilitiesTo excel in this...

  • Flight and Component Quality Assurance Specialist

    3 weeks ago

    Warren, Ohio, United States Lockheed Martin Full time

    Job SummaryWe are seeking a highly skilled Flight and Component Quality Inspector to join our team at Lockheed Martin. As a key member of our quality assurance team, you will be responsible for ensuring that aircraft and components meet the highest standards of quality and safety.Key ResponsibilitiesConduct thorough inspections of aircraft and components to...

  • Process Engineer

    6 days ago

    Warren, Ohio, United States Mindlance Full time

    Job Title: Process EngineerWe are seeking a highly skilled Process Engineer to join our team at Mindlance. As a Process Engineer, you will play a critical role in the design, engineering, and risk assessments of a new manufacturing facility.Key Responsibilities:Participate in the design and engineering of new manufacturing facilities, including FEED, HAZOP,...

  • Manufacturing Engineer III

    2 weeks ago

    Warren, Ohio, United States Cooper Companies Full time

    About CooperSurgicalCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. Our mission is to put time on the side of women, babies, and families at the healthcare moments that matter most in life.Job SummaryThe Manufacturing Engineer III at...

  • Senior Electrical Engineer

    3 weeks ago

    Warren, Ohio, United States CooperSurgical Full time

    About CooperSurgicalCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that put time on the side of women, babies, and families at the healthcare moments that matter most in life.Job SummaryWe are seeking a highly skilled Senior Electrical Engineer to join our team at CooperSurgical. As a key...

  • Manufacturing Engineer III

    2 days ago

    Warren, Ohio, United States Cooper Companies Full time

    About CooperSurgicalCooperSurgical is a leading provider of innovative medical devices and solutions for women's healthcare and fertility. Our mission is to empower healthcare professionals to deliver exceptional care and improve patient outcomes.We are committed to advancing the field of assisted reproductive technology and genomic solutions, and our...

  • Senior Mechanical Engineer

    3 weeks ago

    Warren, Ohio, United States Cooper Companies Full time

    Job Title: Senior Mechanical EngineerWe are seeking a highly skilled Senior Mechanical Engineer to join our team at CooperSurgical. As a Senior Mechanical Engineer, you will be responsible for designing and developing mechanical systems and components for medical devices.Responsibilities:Translate user needs into testable design inputs and conduct thorough...

  • Senior Mechanical Engineer

    4 weeks ago

    Warren, Ohio, United States Cooper Companies Full time

    {"title": "Senior Mechanical Engineer", "description": "Job SummaryWe are seeking a highly skilled Senior Mechanical Engineer to join our team at CooperSurgical. As a key member of our engineering team, you will be responsible for designing and developing mechanical systems and components for medical devices.ResponsibilitiesTranslate user needs into testable...

  • Senior Software Engineer

    2 days ago

    Warren, Ohio, United States CooperSurgical Full time

    Job Title: Senior Software EngineerCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of ART professionals.We are seeking a highly skilled Senior Software Engineer to join our CSI R&D Software team. As a key member of our team, you will be responsible for designing,...

  • Senior Software Validation Engineer

    2 days ago

    Warren, Ohio, United States Cooper Companies Full time

    About Cooper CompaniesCooper Companies is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals and benefit families.We offer a wide range of clinically relevant medical devices, including testing and treatment options, to women's healthcare providers.Our commitment...

  • Senior Electrical Engineer

    2 weeks ago

    Warren, Ohio, United States CooperSurgical Full time

    About CooperSurgicalCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. We offer a wide range of products and services for use by women's healthcare clinicians.Job DescriptionThis is a senior specialist role responsible for designing, prototyping,...

  • Senior Electrical Engineer

    2 weeks ago

    Warren, Ohio, United States CooperSurgical Full time

    About CooperSurgicalCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. Our mission is to put time on the side of women, babies, and families at the moments that matter most in life.Job DescriptionWe are seeking a highly skilled Senior Electrical...

  • Senior Electrical Engineer

    4 days ago

    Warren, Ohio, United States Cooper Companies Full time

    About CooperSurgicalCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. With a wide range of products and services, we strive to put time on the side of women, babies, and families at the moments that matter most.Job SummaryWe are seeking a Senior...

  • Senior Electrical Engineer

    4 weeks ago

    Warren, Ohio, United States Cooper Companies Full time

    About CooperSurgicalCooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. Our mission is to put time on the side of women, babies, and families at the healthcare moments that matter most in life.Job DescriptionWe are seeking a highly skilled Senior...