Sr Quality Engineer, Integrated Systems Requisition ID: 66823 Date: Dec 6, 2024 Location: Exton, Pennsylvania, US Department: Quality Description: 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 Senior Quality Engineer provides quality direction, governance, and Quality Management System best practices to syringe and drug containment programs. This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment. This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets. They will partner with R&D, Regulatory, Supplier Quality, Analytical Labs, Supply Chain, and Operations in support of product development, launch, and post market surveillance activities. The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. This role will initially operate within the regulatory confines of a GMP pharmaceutical and medical device testing laboratory and must ensure all projects meet the applicable regulatory expectations. The initial principal responsibility of this role is to lead a gap-analysis of laboratory operations against ISO 17025 requirements. **Essential Duties and Responsibilities:** + Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard. + **Project Planning:** Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resource allocation and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify risks to project success and implement mitigation strategies to minimize impact. + **Safety and Compliance:** Responsible for ensuring all relevant safety practices and procedures are employed. Responsible for ensuring cGMP regulations and QA procedures are adhered to for all relevant work. + **Coordination:** Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met. + **Resource Management:** Manage project budgets, scope, resources, and timelines effectively to optimize project outcomes. Identify gaps and changes and ensure stakeholder and resource manager alignment on current project needs. + **Product Development and Manufacturing** : + Provide Quality Engineering direction to multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements. + Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.) + **Risk Management:** Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures. + **Quality Management System** : Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions + Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS. **Basic Qualifications:** + Bachelor Degree in Engineering or Science required + Minimum 6 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities + Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success + Relevant work history and/or experience may be considered in lieu of degree + In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971 + Strong communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders. + Excellent written, critical reading, effective problem solving, and oral communication skills + Ability to work independently, multi-task and thrive in fast-paced environment + Strong problem-solving skills including root cause failure analysis methods + Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities. + Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point + Be aware of all relevant SOPs as per Company policy as they relate to this role + Able to comply with the company’s safety policy at all times **Preferred Knowledge, Skills and Abilities:** + ASQ certification (CQE or CQA) + ISO 17025 Auditor or Lead Auditor Training / Certification + Green or Black Belt certification + Experience with MasterControl, SAP, Share Point, Teamcenter + Experience with ISO 11040, ISO 11607 a plus **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. + Must maintain the ability 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 judgments + Observe and interpret situations, analyze and solve problems + Effectively communicate and interface with various levels internally and with customers **Competencies/Authorities** + Non-US only where required for certain levels \#LI-CT1 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.