Allergan Quality Engineer IV (Operations/CoolSculpting) in Dublin, California
Quality Engineer IV (Operations/CoolSculpting)
Dublin, California, United States at https://agn.referrals.selectminds.com/jobs/5095/other-jobs-matching/location-only
Apr 18, 2018Post Date
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.
This role is responsible for quality support for manufacturing, servicing, warehousing and distribution of Allergan manufactured products. The Quality Engineer IV will coach manufacturing quality personnel on GMP and SOP compliance and empower them to identify and escalate quality issues, to ensure overall quality of the product.
Main Areas of Responsibilities
Responsible for driving continual process improvements in responsible areas of the business. Drive quality and manufacturing improvements to assure that processes are in a state of control.
Develop and maintains effective relationships and integrate activities with other departments and suppliers.
Review and approve changes made to product and processes and validation/qualification protocols and reports
Work with internal customers and suppliers to ensure that non-conformances, failure analysis reports and deviations are appropriately investigated, documented, reviewed and approved.
Responsible for drafting and/or updating Quality Procedures for Quality Operations functions
Initiate and develop standards and methods for inspection, testing, and evaluation as necessary. Assure product compliance to specifications through implementation of inspection criteria, procedures and training.
Establish and maintain quality metrics.
Identify and lead projects and initiatives to improve the quality system.
Coach and develop other team members.
Perform internal audits and other related duties as assigned.
Ability to travel 25% of the time.
Minimum of 4-7 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
Proficiency in reading and interpreting mechanical drawings and GD&T.
Knowledge of QSR and ISO 13485.
Medical Device Auditor certification preferred.
Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook. Preferred Requirements
Knowledge of quality/continuous improvement tools (SPC, Statistics, DOE, Six Sigma) preferred
Good oral and written communication skills.
Ability to write reports, data analysis, and business correspondence.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.
Ability to work with mathematical concepts such as probability and statistical inference.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to use MS Excel to perform calculations and interpret results/data.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to read technical literature and documents and extract important concepts.
Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Allergan complies.
- Bachelors degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred.
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.