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Quality Assurance Engineer IV

Company: Allergan
Location: Irvine
Posted on: November 11, 2019

Job Description:

Envision working with energetic colleagues and inspirationalleaders. Now, place yourself in that mix; leading discussions, asking the rightquestions and driving results.

What Your New Manager Wants You To KnowReporting to the Directorof QA (TPCQ- Medical Device), the position will support the QualityManagement System and provide strong leadership in the 3rd partymedical device Quality function amongst peers, ensuring that functional activitiesare aligned with overall company goals and strategies.?These activities include working closely withthe company?s 3rd party medical device manufacturers and internalstakeholders to ensure compliance with appropriate regulatory requirements forall targeted commercial markets.? Thesemanufactures primarily include third-party contractors, and service/supplyvendors but may Allergan wholly owned facilities be encompassing medicaldevices and combination products as applicable to the portfolio in scope.? .? ?YOU ARE more than just a title, YOU ARE??A strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.Firstclass team player: collaborate acrossmultiple disciplines to ensure compliance and ability to influencecross-functional teams and senior leadership.

You Will

  • Support interactions with regulatory authorities to ensure compliance with regulations associated with activities involving commercial product supply chain.
  • Review and approve changes made to product and processes managed by third party medical devices and combination products, suppliers.?
  • Work with third party suppliers to ensure that non-conformances and deviations are accurately documented, reviewed and approved.?
  • Support Device Investigation Lab in Irvine conducting accurate returned device investigations and device history record reviews where required.
  • Support R&D by representing third party quality for new product development, new region expansion, or a manufacturing product line extension to ensure that the appropriate external manufacturing facilities and process are in place to support commercialization and the supply chain.
  • Review and approve technical/validation protocol and reports.
  • Develop and maintain effective relationships and integrate activities with other departments and suppliers.
  • Support the development and updates to the Risk Management Files for Allergan medical device and combination products for thirdparty products.#LI-PD1 You Bring
    • Bachelor?s degree in engineering, physical or life sciences with a minimum of 5-10 years? experience in the medical device field with experience in medical regulations.
    • Proven experience working with medical device companies? Quality Management Systems.
    • Experience reviewing and approving production drawings, shop orders, and documentation (including structuring bill of materials).
    • Computer literate experience; use of word processing, spreadsheets, complaint handling and change control systems.
    • Expertise in cGMP?s, guidelines, and regulations applicable to the FDA and comparable international regulatory agencies.
    • Expertise in ISO 13485 experience in Medical Device?s.
    • Experience working with product and process validations.
    • Experience working with medical device suppliers including review of non-conforming materials, CAPAs, audit finding etc.
    • Experience in sterility and packaging requirements for medical devices.
    • The ability to recognize problems and take corrective measures.In this role, we?re looking fora leader who will:

      • Act as an Owner
      • Be Excellence Focused
      • Act as an InfluencerWe Will Give You ?The Allergan Edge?

        At Allergan, we define an 'edge'as something that sets us apart, gives us an advantage and strengthens us to bebetter ? for our customers, patients, investors and each other. Our 'edge' isour colleagues, and we are committed to making Allergan the best place for themto work and achieve career goals.

        How do we do this? We Engage, Develop, and Reward our colleagues.Engage. From Day 1, you are a bold leader who wants to make animpact. We listen to your ideas and questions, so we can be even better at whatwe do.Develop. Learn every day, build new skills every day. We prioritize development,so our leaders are always ready for the next challenge and opportunity.Reward. Exceptional performance creates exceptional opportunitiesand rewards. Financial awards and incentives are just a part of this - weinvest in our people; celebrate success through recognition programs; andpromote healthy lifestyles and work-life balance.

Keywords: Allergan, Irvine , Quality Assurance Engineer IV, Engineering , Irvine, California

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