Allergan Design Quality Engineer III in Pleasanton, California

Design Quality Engineer III

Pleasanton, California, United States at

Jul 02, 2018Post Date

181128Requisition #

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 pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective 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 every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Description

The primary responsibility of this position is to assume a lead role in providing Quality Engineering support for Sustaining and New Product Development projects. The Design Quality Engineer is responsible for facilitating compliance to applicable internal and external requirements during the life cycle management of design changes and commercialization of new products.

Main Areas of Responsibilities

  • Design Control Activities:

  • Collaborate with Design teams, provide technical support, and facilitate the successful execution of the Design Control Process.

  • Responsible for Quality Engineering deliverables required within the product development process.

  • Support Design Verification and Validation activities, including review of verification & validation protocols and reports

  • Assist in the analysis of product requirements and specifications. Participate in change request and design review team meetings as required.

  • Lead / coach / guide engineers to facilitate compliance and to support process improvements.

  • Ensure that technical information is accurate and in compliance with quality and regulatory requirements.

  • Risk Management Activities:

  • Maintain the overall Risk Management process in accordance with ISO 14791 and other applicable standards. Work cross-functionally with the Subject Matter Experts from R&D, Clinical, Medical Safety and Operations to ensure a comprehensive risk management process.

  • Conduct Post-Market Surveillance Reviews and Feedback into Risk Management

  • Usability Activities:

  • Support Integration and Implementation of new Usability Process, Procedure and Templates.

  • Provide quality support for the Usability plan, report, and file.

  • Implement Design Control process improvements to ensure a more effective, efficient, and compliant design control process.

  • Maintain the DHF post product commercial release.

  • Ensure that technical information is accurate and in compliance with international regulatory requirements.

  • Perform all duties with minimal oversight required from direct manager.

Minimum Requirements

  • Advanced knowledge of, and proficiency with medical device development life cycles and Design Control processes.

  • Ability to handle complex issues and exercise judgement, based on experience, with minimal oversight from manager.

  • Knowledge of QSR, ISO 13485, and ISO 14971

  • Knowledge of IEC 62366, IEC 60601, Biocompatibility, and Aging Studies preferred.

  • Ability to write Verification / Validation protocols and reports.

  • Problem solver.

  • Six sigma green belt preferred.

  • Competent using office software including MS Word, Excel, PowerPoint, and Outlook.

  • Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, ISO 14971, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Allergan complies.

Additional Requirements and Education:

  • Bachelor’s degree in science or engineering.

  • Minimum of 5 years of quality engineering experience in an FDA-regulated medical device manufacturing environment.

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.