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 Principal 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. In addition, this role will suport workstreams associated with resolving quality issues, addressing complaints, coordinating validations and other projects in support of Integrated Systems. 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 to ensure consistency across product platforms which promote development and manufacturing high volume efficiencies and ensure product platforms are compliant with regulatory and business requirements throughout the complete development lifecycle including commercialization, sustainment, 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 is also responsible for Quality oversight of documentation submitted to regulatory authorities in support of commercial launch and life-cycle management. Essential Duties and Responsibilities * Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard. * Product Development, Risk Management, and Manufacturing: * Partner with R&D to provide Quality Engineering direction to multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements, ensuring sustainable and scalable solutions.. * 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.) * Oversee and provide direction to cross-functional teams on product development DHF/DMR documentation including but not limited to failure analyses, risk management activities, FMEAs (application, design and process), process flow analyses, design of experiments, process capability analyses, quality inspection procedures including sampling plans, and test method validation * Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures. * Recommend, evaluate, and lead initiatives to implement process changes that are designed to continually improve the quality management system. * Interface with stakeholders for quality issues, technical information, specification, etc. * Lead discussions/workstreams with R&D to ensure successful design transfers of new or updated products and manufacturing transfers from Product Development into Manufacturing, in collaboration with Operations and third party providers. Additional Responsibilities 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 * Drive proactive, preventative behaviors and via a strong CAPA and to resolve product quality issues for commercialized products. * Lead in Lean Sigma programs and activities towards improvement of processes or optimization of methods Miscellaneous: * Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS. * Drive continuous quality improvement projects * Other duties as assigned * 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 Education * Bachelor's Degree in Engineering or Science required and * Chemistry or Engineering Degree preferred and * Graduate degree preferred Work Experience * Minimum 8 years of experience required and * Relevant work history and/or experience may be considered in lieu of degree and/or years of experience required and * Previous experience with MasterControl, SAP, Share Point, Teamcenter preferred * Subject Matter Expert level of understanding of ISO 13485 and 21CFR Part 820, 210, and/or 211 requirments * Experience with EU GMP Annex I, and PDA a plus * Subject Matter Expert level of understanding of using quality management tools, applicable standards, policies, and procedures - APQP, PPAP, MSA, SQC etc Preferred Knowledge, Skills and Abilities * Preferred previous experience with Master Control, SAP, SharePoint, Teamcenter * Subject Matter Expert level of knowledge of using Six Sigma and SPC tools and techniques * Expertise with MicroSoft Oiffce Suite (Excel, Word, Visio, Project, PowerPoint, OneNote) * Proficiency in statistical software (Minitab, JMP, etc.) * Excellent project management, presentation, writing, verbal, computer, problem solving, interpersonal and communication skills, including the ability to tailor messaging to all levels of the organization. * Ability to adapt to frequent changes, unexpected events and still yield an effective outcome, as well as manage competing demands, make timely and sound decisions, even under conditions of risk. * 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. License and Certifications * Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred * Quality\Certified Quality Engineer-ASQ (CQE or CQA) Upon Hire preferred * ISO 13485 Auditor or Lead Auditor Training / Certification Upon Hire preferred Travel Requirements 10%: Up to 26 business days per year Physical Requirements Sedentary-Exerting up to 10lbs/4kgs 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. Additional 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 * 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 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 [email protected]. 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.