Current jobs related to Director of Quality Assurance and Regulatory Affairs - Plymouth - Interrad Medical

  • Regulatory Affairs Specialist

    2 weeks ago

    Plymouth, United States The Judge Group Full time

    Our client is currently seeking a Regulatory Affairs Specialist for a 12 month + contract. NOTE: THIS IS A HYDRID ROLE. 3 DAYS OF THE WEEK THE TEMP WILL BE REQUIRED TO WORK ONSITE. TEMP-PERM FOR THE RIGHT PERSON• Support daily Regulatory Affairs function eg; compliance to 21 CFR 820,807,803 ISO 13485 requirements, Company policies, operating procedures,...

  • Regulatory Affairs Specialist III

    2 months ago

    Plymouth, United States Integer Holdings Full time

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success...

  • Senior Director, Advertising and Promotion Regulatory Affairs

    2 weeks ago

    Plymouth Meeting, Pennsylvania, United States Organon Full time

    {"Responsibilities": "Lead the TeamAs the Senior Director, Advertising and Promotion Regulatory Affairs, you will lead a team of Advertising and Promotion reviewers responsible for review and approval of assigned projects. This may include products in all phases of development through registration and mature products.Key ResponsibilitiesLead the team...

  • Regulatory Affairs Coordinator

    4 weeks ago

    Plymouth, United States Zentis North America LLC Full time

    Regulatory Affairs Coordinator Zentis is Europe's number one fruit processing company and one of the leading brand manufacturers of jams, sweets and custard-based dessert. The Company's North American operations are located in Philadelphia, Pennsylvania and Plymouth, Indiana, where we produce fruit and dairy preparations for a variety of customers including...

  • Senior Regulatory Affairs Specialist

    4 months ago

    Plymouth, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...

  • National Director, Field Medical Affairs

    2 months ago

    Plymouth Meeting, United States Inovio Pharmaceuticals Full time

    Job DescriptionJob DescriptionAbout INOVIOINOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from infectious diseases, cancer, and diseases associated with HPV. Our DNA medicines in development are delivered using our proprietary smart device to produce immune responses against targeted...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Plymouth Meeting, Pennsylvania, United States Organon & Co. Full time

    Job SummaryOrganon & Co. is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the quality and compliance of our products.Key ResponsibilitiesQuality Assurance: Develop and implement quality assurance procedures to ensure compliance with...

  • Food Quality Assurance Manager

    2 weeks ago

    Plymouth, Wisconsin, United States Masters Gallery Foods Inc Full time

    About Masters Gallery Foods IncWe are a company that strives to make a positive impact on the lives of those we influence, whether it's our employees, partners, or individuals in our communities.Job DetailsJob Title: Food Quality Assurance ManagerJob Summary: We are seeking a highly motivated and experienced Food Quality Assurance Manager to join our team at...

  • Senior Specialist, Quality Assurance Expert

    2 days ago

    Plymouth Meeting, Pennsylvania, United States Organon & Company Full time

    Job SummaryWe are seeking a highly skilled Senior Specialist, Quality Assurance to join our team at Organon & Company.Main ResponsibilitiesEnsure all products are stored and distributed in accordance with Organon and regulatory requirements.Meet internal and external customer demands, product licenses, and contractual obligations.Collaborate with the Quality...

  • Senior Specialist, Quality Assurance Expert

    7 days ago

    Plymouth Meeting, Pennsylvania, United States Organon & Company Full time

    Job SummaryWe are seeking a highly skilled Senior Specialist, Quality Assurance to join our team at Organon & Company.Key ResponsibilitiesEnsure all products are stored and distributed in accordance with Organon and regulatory requirements.Meet internal and external customer demands, product licenses, and contractual obligations.Collaborate with Quality...

  • Lead Quality Assurance Engineer

    4 weeks ago

    Plymouth, Michigan, United States Coherent Full time

    Job Overview Coherent Corp. is seeking a Lead Quality Assurance Engineer to enhance our Laser Systems division. This pivotal role involves the formulation, execution, and upkeep of quality assurance and control frameworks for our Global Tools Group. The Lead Quality Assurance Engineer will collaborate closely with the Business Unit Leader and engage with...

  • Senior Specialist, Quality Assurance Expert

    7 days ago

    Plymouth Meeting, Pennsylvania, United States Organon Full time

    Job DescriptionAt Organon, we are committed to delivering innovative health solutions that empower women and their families to live their best lives. We are seeking a highly skilled Senior Specialist, Quality Assurance to join our team.Key Responsibilities:Ensure compliance with all applicable Organon and regulatory requirements for product storage and...

  • Senior Quality Assurance Specialist

    1 week ago

    Plymouth Meeting, Pennsylvania, United States Organon Full time

    Job SummaryOrganon is seeking a highly skilled Senior Specialist, Quality Assurance to ensure the compliant and reliable supply of our products in the US market. The successful candidate will be responsible for ensuring that all products are stored and distributed in accordance with all applicable Organon and regulatory requirements.Key...

  • Senior Quality Assurance Specialist

    3 days ago

    Plymouth Meeting, Pennsylvania, United States Organon & Co. Full time

    Job DescriptionThe PositionEnsure Quality and ComplianceAs a Senior Specialist, Quality Assurance, you will be responsible for ensuring that all products are stored and distributed in accordance with all applicable Organon and regulatory requirements. This includes executing permanent audit readiness, tracking partner Quality metrics, providing coaching and...

  • Quality Assurance Inspector

    1 week ago

    Plymouth, Michigan, United States EOTech Full time

    Job Title: Quality Assurance InspectorEOTech is seeking a highly skilled Quality Assurance Inspector to join our team. As a Quality Assurance Inspector, you will play a critical role in ensuring the quality of our products by examining them for defects or deviations from specifications.Key Responsibilities:Approve in-process production by confirming...

  • Quality Assurance Specialist

    1 week ago

    Plymouth, Michigan, United States Stardock Corporation Full time

    Associate Quality Assurance AnalystStardock Corporation is seeking a detail-oriented and organized Associate Quality Assurance Analyst to join our team. As a key member of our QA team, you will play a crucial role in ensuring the quality and usability of our software and games.Key Responsibilities:Software and Game Testing: Conduct thorough testing of our...

  • Quality Assurance Specialist

    1 week ago

    Plymouth, Michigan, United States Plastipak Holdings Full time

    Quality Assurance Internship OpportunityPlastipak Holdings is seeking a highly motivated and detail-oriented individual to join our Corporate Quality Lab as a Quality Assurance Intern. As a member of our team, you will have the opportunity to work closely with engineers and production teams to conduct tests, compile data, and tackle real-world...

  • Quality Assurance Specialist

    5 days ago

    Plymouth, Michigan, United States Plastipak Holdings Full time

    Quality Assurance Internship OpportunityPlastipak Holdings is seeking a highly motivated and detail-oriented individual to join our Corporate Quality Lab as a Quality Assurance Intern. As a member of our team, you will have the opportunity to work closely with engineers and production teams to conduct tests, compile data, and tackle real-world...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Plymouth Meeting, Pennsylvania, United States Organon Full time

    Job SummaryOrganon is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that all products are stored and distributed in accordance with all applicable regulations and standards.Key ResponsibilitiesEnsure compliance with Good Distribution Practice...

  • Principal Design Assurance Engineer

    4 months ago

    Plymouth, United States Accordance Search Group Full time

    Our client is an exciting medical technology company searching for a Principal Design Assurance Engineer. In this role you will lead design assurance activities and initiatives supporting Product Development projects including establishing and improving product design requirements, design review activities, risk management and the development of testing...

Director of Quality Assurance and Regulatory Affairs

4 months ago

Plymouth, United States Interrad Medical Full time

The Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Medical. This position will provide hands on leadership, tactical implementation, follow-up, and documentation that demonstrates that the quality system is incompliance with QSR and ISO 13485 requirements as well as country/region specific requirements.


Responsibilities

  • Lead company-wide efforts to maintain and continuously improve the Quality Management System for Interrad Medical to ensure the quality of SecurAcath and other devices and components
  • Oversee QMS training for employees
  • Ensure compliance with the US FDA quality system requirements, EU MDR regulations, ISO 13485 standards, and other applicable regulations and standards across the globe
  • Guide the company’s regulatory strategy
  • Manage regulatory audits and inspections from preparation to responses
  • Includes Medical Device Single Audit Program (MDSAP)
  • Coordinate both internal audits and supplier audits
  • Lead risk management activities from assessment to monitoring
  • Support supplier quality management activities
  • Oversee complaint handling process
  • Support product return and failure analysis
  • Manage corrective and preventive action process
  • Lead post-market surveillance activities including writing and updating PSUR and SSCP reports
  • Oversee document controls including the creation, approval, distribution, and retention of documents as well as the records that are produced
  • Lead quarterly management review meetings for the company
  • Cross-functional collaboration with engineering on product development
  • Cross-functional collaboration with engineering on test methods and with operations on inspection methods
  • Other duties as assigned


Qualifications

  • Bachelor's degree in a relevant discipline; master’s degree preferred.
  • Minimum of ten (10) years of experience in both quality and regulatory in medical devices
  • Understands FDA regulations, MDR regulations, ISO standards and other applicable global regulatory requirements and standards
  • Understands current Good Manufacturing Practices (cGMP)
  • Post-market surveillance experience including PSUR and SSCP
  • Experience with QMS software; experience with Grand Avenue software is preferred.
  • Experience managing regulatory audits and inspections
  • ISO 13485 certified internal auditor is preferred