Title:  Quality Engineering Manager

Onsite position in Tempe, AZ

Who We Are:

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’.

Basic Qualifications: 

• Education or Equivalent Experience: Bachelor's in Engineering, Chemistry or Science, or equivalent

• Experience: 8-10 years of experience

• Relevant work history and/or experience may be considered in lieu of degree and/or years of experience.
• Experience with ISO 13485 and 21CFR Part 820, 210, and/or 211

Additional Requirements:

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the availability to work well with others in a variety of situations.
• Maintain high attention to detail, accuracy and overall quality of work.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgements
• Observe and interpret situations, analyze and solve problems.

• Effectively communicate and interface with various levels internally and with customers.

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary. Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. If necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet. The ability to be able to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions is required.

Preferred Knowledge, Skills and Abilities:

• Preferred previous experience with Master Control, SAP, SharePoint, Teamcenter
• Experience using Six Sigma & 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.

Travel Requirements:

• Less than 5%

Physical and Mental Requirements:

• Sedentary: exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body.  Sedentary work involves sitting most of the time.  Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

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West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.