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Title:  Sr. Quality Engineer

Requisition ID:  34881
Date:  Oct 19, 2021

Scottsdale, Arizona, US

Department:  Quality



Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.


At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.


Job Summary:

In this role, you will lead and facilitate the implementation of quality initiatives and continuous improvement to support the company Quality Management System. The position will lead, coach, facilitate, and support problem solving, analysis of data, and continuous improvement activities.  Drive and oversee Quality functions to support manufacturing operations. Assists in establishing systems to support the facility to drive continuous improvements and minimize the costs of non-conformance. Plans, schedules, executes, and communicates all items regarding Quality issues, events, complaints, validations, and other projects to the QA Manager and/or other interested parties. Performs all duties associated with compliance-related items for ISO standards and cGMPs.


Essential Duties and Responsibilities:

Support the development and maintenance of the total QMS for the company to ensure compliance to standards, including ISO 13485, ISO 14971, FDA 21CFR820

Develop risk assessment and mitigation plans through FMEA’s, and other risk assessment tools.

Oversee equipment, process, and design validations - including generation of protocols and reports, evaluation of process capability, and providing/presenting data to responsible departments.

Liaison with company and Customers on Quality matters.

Lead regional site Quality Engineers/ Specialists in meeting customer expectations in complaint and nonconformance investigation responses. Aid in assuring expected turn-around time metric is attained. 

Identify manufacturing and development constraints. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence.

Assists facility with Quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques

Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC programs

Prioritize, plan, and execute work activities in alignment with department and company priorities with minimal supervision.

Conduct internal and external quality management system audits, publish findings, and recommendations.

Perform all other duties as assigned


Basic Qualifications: 

Bachelor’s degree in Engineering related field

Minimum 5 years or experience in Quality (preferably in Medical Device)

Experience with Customer interface and meeting customer expectations

Experience with Project Management Tools, Quality Risk Management, and Six Sigma problem solving tools

Preferred Knowledge, Skills and Abilities:

Support and contribute in Lean Sigma programs and activities towards delivery of the set target

Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.

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:

Must be able to travel up to 10% of the time


Physical & Mental Requirements:

Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.

Maintain high attention to detail, accuracy, and overall quality of work.

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

Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description







West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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