This role is hybrid at Exton, PA. Candidates applying must be within a 50 mile radius to the job location.

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:

In this role, the Quality Engineer is accountable for supporting research and development activities within a multi-functional team environment for medical devices. The Quality Engineer will provide analytical support within the Quality team and will work closely with the research and engineering teams to identify areas of improvement within the Quality Management System. The Quality Engineer will handle projects and tasks in support of product development and will play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements.

The Quality Engineer will also execute transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including site audit support.

Essential Duties and Responsibilities:

• Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard
• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
• Collaborate with research and development teams on the development of DHF documents, specifically in regard to facilitating document control activities.
• Partner with and support the New Product Development Quality team in product development activities including but not limited to Failure Investigations, CAPAs, Non-Conformance assessments, audit findings, deviations, and QMS procedural improvements.
• Support the development of product development QMS procedures and work instructions.
• Work cross-functionally with individuals and project or extended teams to ensure success of projects
• Drive solutions to ensure internal customer related problems/issues are communicated
• Establish routine communication strategies for project tracking and prioritization
• Drive continuous quality improvement projects
• Assure escalation of quality related issues to ensure effective remediation
• Attend program meetings as required as part of extended program teams
• Liaison with company and customers on Quality matters
• Other duties as assigned

Basic Qualifications:

• Bachelor's Degree in Engineering required
• Minimum experience of 3 years in regulated Quality Systems/ Quality Assurance/ Design Quality role
• Relevant work history and/or experience may be considered in lieu of degree.
• Experience with Document Control
• Excellent written and verbal communication skills
• Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point

Preferred Knowledge, Skills and Abilities:

• Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities
• Experience with quality systems such as ISO 13485, 21 CFR 820.30
• Experience with MasterControl, SAP, Share Point, Teamcenter
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual
• 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:

• 5%: Up to 13 business days per year

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

#LI-DJ1

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.