ONSITE POSITION IN TEMPE, AZ

Who We Are:

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 support all quality system and functions for a medical device manufacturing facility. 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, 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 site Quality Engineers/Quality Specialists in meeting customer expectations in complaint investigation responses. Aid in assuring expected turn-around time metric is attained.
• Support site Quality Engineers, Manufacturing/Project Engineers, and other site staff in investigating CAPAs and executing implementation of corrective action plans. Aid in assuring expected turn-around time metrics are maintained.
• Assist in developing site Quality Engineer staff in usage of tools and processes for customer complaint investigations/continuous improvement.
• Analyze data, process capabilities, customer concerns and expectations and any other leading or lagging indicators which may be used to improve product and process knowledge.
• 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.
• Participates in ISO and corporate quality system audits.
• Utilizes knowledge of International Standards and Federal Regulations (i.e. ISO 13485/21 CFR 820) to maintain the quality management system.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

Basic Qualifications:

• Bachelor’s degree in engineering or similar degree, or equivalent work experience.
• Experience working within FDA CFRs or other regulated environments.
• Experience completing CAPAs and/or complex investigations.
• Minimum of 5 years of experience in the same or similar role.

Preferred Knowledge, Skills and Abilities:

• Able to interface with customers and meeting customer expectations
• Experience operating within the Medical Device regulations.
• Ability to work with interdisciplinary teams.

• Experience with Project Management tools and able to provide support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Willingness to learn manufacturing procedures and aid with improvements via Quality Management.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times

Physical and Mental Requirements:

• Need to have extreme attention to detail
• Ability to work in an office and/or manufacturing environment. May need to stand or sit for extended periods of time
• Medical component and device manufacturing require strict adherence to standards. Must be able to tolerate fumes and from various manufacturing processes, also subject to heat and cold, as well as, loud noise
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• Use written and oral communication skills
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems.
• Sedentary – exerting up to 1-lbs of force occasionally, and/or negligible amount of force frequently or constantly to lift, 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 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 Apply.Accommodation@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.