Quality Assurance Engineer IV
Posted on: November 11, 2019
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.
- 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,
- Work with third party suppliers to ensure that non-conformances
and deviations are accurately documented, reviewed and
- Support Device Investigation Lab in Irvine conducting accurate
returned device investigations and device history record reviews
- 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
- 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
- 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
- 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
Didn't find what you're looking for? Search again!