Quality Engineering Manager

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary

The Quality Engineer Manager provides quality leadership to the Quality Engineers responsible for executing all items regarding quality issues, complaints, validations and other projects in support of medical device manufacturing. This role will oversee the Quality Engineering team to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements. This role will act as the Quality Manager delegate with approval authority.

Essential Duties and Responsibilities

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Provide Quality oversight and direction for Quality Engineers.
• Provide direct supervision, resolves personnel issues, conducts performance evaluations and performs supervisory discipline as necessary.
• Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system.
• Provide quality oversight, author, review, and/or approve site documentation (validation, change control, SOPs, WKIs, etc).
• Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, etc. Provide leadership and direct input on any nonconformance, deviation, or excursion that may occur and drive to closure.
• Direct involvement with FDA and ISO inspections and any external audits/assessments to ensure that the facility Quality Management System is properly represented. May act as lead for ISO and customer audits.
• Interface with customers for quality issues, technical information, specification, agreements, audits, etc.
• Recruit, train, develop, and lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a ‘culture of quality’.

Additional Responsibilities

Education

• Bachelor's Degree in Engineering or Science required and
• Chemistry or Engineering Degree preferred and
• Graduate degree preferred

Work Experience

• Minimum 8 years Minimum 8-10 years of experience required and
• Relevant work history and/or experience may be considered in lieu of degree and/or years of experience required and
• Previous experience with MasterControl, SAP, Share Point, Teamcenter preferred and
• Experience with ISO 13485 and 21CFR Part 820, 210, and/or 211 preferred

Preferred Knowledge, Skills and Abilities

• Preferred previous experience with Master Control, SAP, SharePoint, Teamcenter
• Experience using Six Sigma and SPC tools and techniques
• Ability to use Excel, Word programs
• Must be able to operate and maintain office equipment (i.e. copy machines, multi-media, etc.).
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

License and Certifications

• Engineering - General\ASQ Certified Quality Engineer (CQE or CQA) Upon Hire preferred and
• Manufacturing\Six Sigma Green Belt Certification Upon Hire preferred or
• Manufacturing\Lean Six Sigma Black Belt Upon Hire preferred

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs