Title:  Senior Supplier Quality Engineer

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 Supplier Quality Engineer will support Operations Quality to ensure suppliers deliver products which comply with requirements and specifications.  This role will be a key liaison between Operations Quality, Global Quality, and suppliers. They will drive improvement in the supply chain through resolution of supplier nonconformances, identification of supplier quality improvement activities, and implementation of quality strategies and objectives.  They will partner with Operations Quality and Procurement to maintain and improve the Supplier Management System which includes supplier audits, supplier corrective actions, and supplier performance.  They will contribute to the development, establishment, and maintenance of supplier quality engineering methodologies, systems, and practices.  Working in multi-functional teams, they will be responsible to guide technical evaluations, analysis, and related data acquisition processes to ensure quality objectives are achieved. Additionally, this role will identify and implement improvements within the Quality Management System.  The Senior Supplier Quality Engineer will be a strong advocate for product, process, and system quality at all stages of product realization.

The Senior Supplier 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.
• Partner with Global Supplier Quality, R&D, and Procurement to resolve supplier nonconformances and issue supplier corrective actions.
• Responsible for all aspects of quality of supplied components and assemblies.
• Audit suppliers and contract manufacturers.
• Define, monitor, and manage supplier quality metrics.
• Develop and deploy quality strategies, programs, and roadmap for contract manufacturers and critical suppliers.
• Responsible for developing Supplier Score Cards.
• Support the Procurement team in conducting routine QBR of critical suppliers by providing quality metrics
• Partner with organizational leaders and industry peers to drive quality initiatives, systems, and methods implementation to meet quality objectives.
• Represent company with suppliers to articulate quality systems, review issues, provide feedback and enforce corrective / preventive actions.
• Partner with Operations Quality to provide guidance on incoming inspection process.
• Support the supplier selection process.
• Partner with Engineering team to recommend solutions to defects and problems.
• Meet company and departmental goals in the continuous improvement of all products, services, and processes, including the West QMS.
• Provide direction and support for technical and design review activities as a Quality representative Supplier SME.
• Work cross-functionally with individuals, project, and extended teams to provide guidance and ensure success of projects
• Attend program meetings as required as part of extended program teams
• Author and review supplier related QMS procedures and work instructions
• Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings
• Works with minimal supervision to evaluate gaps and lead projects to close them
• Establish routine communication strategies for project tracking and prioritization
• Drive continuous quality improvement projects
• Adhere to all company policies
• Follow all safety rules and safety procedures
• Must observe all good housekeeping practices
• Other duties as assigned

Basic Qualifications: 

• Bachelor Degree in Engineering or related technical discipline
• Minimum 5 years of related experience
• Expertise in quality management tools.  Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
• Relevant work history and/or experience may be considered in lieu of degree

• Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971
• Working knowledge of supplier quality management from product development to mass production.
• Strong project management skills
• Excellent written and oral communication skills
• Excellent critical reading and writing skills
• Must have effective problem solving and interpersonal skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Problem solving including root cause failure analysis methods
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Adhere to 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.

Preferred Knowledge, Skills and Abilities:

• ASQ certification (CQE or CQA)
• Green or Black Belt certification
• Graduate degree
• Strong project management skills
• Previous experience with MasterControl, SAP, Share Point, Teamcenter
• Experience with IATF16949, ISO 60601, ISO 62366, ISO 11607 a plus

Travel Requirements:

• Must be able to travel up to 25% 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

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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.