Quality Assurance Engineer IVAllergan, Inc - Irvine, CA
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Reporting to the Associate VP of TPM and International Quality, the position will support the Quality Management System and provide strong leadership in the 3rd party medical device Quality function and among peers, ensuring that departmental activities are aligned with overall company goals and strategies.
These activities include working closely with the company’s 3rd party medical device manufacturers to comply with appropriate regulatory requirements for all targeted commercial markets.
These include Allergan wholly owned facilities and third party contractors, and service/supply vendors.
Responsibilities are for the medical devices and combination products both above plant and third party oversight.
Standards and regulatory requirements are an evolving process, particularly in the major markets served. The corporate medical device/combo product quality engineering function supplies information for product registrations and assures that all Allergan products comply with the appropriate regulations and Allergan requirements.
Support interactions with regulatory authorities to ensure compliance with regulations associated with activities involving commercial product supply chain.
Reviews and approves changes made to to product and processes managed by third party medical devices and combination products, suppliers.
Works with third party suppliers to ensure that non-conformances and deviations are accurately documented, reviewed and approved.
Supports Device Investigation Lab in Irvine conducting accurate returned device investigations and device history record reviews where required.
Supports 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.
Reviews and approves 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 third party products.
\t\t\t\t\t\t\tKnowledge, Skills and Abilities:
Excellent written and verbal communication skills.
Experience reviewing and approving production drawings, shop orders, and documentation (including structuring bill of materials).
Computer literate; 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.
Minimum Requirements and Education:
Bachelor’s degree in engineering, physical or life sciences with a minimum of 4-7 years’ experience in the medical device field with experience in medical regulations.
Proven experience working with medical device companies’ Quality Management Systems.
Experience with problem solving/trouble shooting and risk assessment.
Proven ability to generate results.
13 days 21 hours ago
applyQuality Assurance Engineer IV Allergan, Inc - Irvine, CA, United States
Allergan, Inc. operates as a multi-specialty health care company primarily in the United States, Europe, Latin America, and the Asia Pacific. The company discovers, develops, and commercializes pharmaceutical, biological, medical device, and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, urological, and other specialty markets. It operates in two segments, Specialty Pharmaceuticals and Medical Devices. The Specialty Pharmaceuticals segment produces a range of pharmaceutical products, including ophthalmic products for dry eye, glaucoma, inflammation, infection, allergy, and retinal disease; Botox for certain therapeutic and aesthetic indications; skin care products for acne, psoriasis, eyelash growth, and other prescription and physician-dispensed skin care products; and urologics products. The Medical Devices segment offers a range of medical devices, such as breast implants for augmentation, revision, and reconstructive surgery, as well as tissue expanders; and facial aesthetics products. The company sells its products to drug wholesalers, independent and chain drug stores, pharmacies, commercial optical chains, opticians, mass merchandisers, food stores, hospitals, group purchasing organizations, integrated direct hospital networks, ambulatory surgery centers, government purchasing agencies, and medical practitioners. It focuses on eye care professionals, neurologists, physiatrists, dermatologists, plastic and reconstructive surgeons, aesthetic specialty physicians, urologists, urogynecologists, and general practitioners. The company has collaboration agreements with Molecular Partners AG; Spectrum Pharmaceuticals, Inc.; and Serenity Pharmaceuticals, LLC. Allergan, Inc. was founded in 1948 and is headquartered in Irvine, California.
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