Title:  Supplier Quality Engineer

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, the Senior Supplier Quality Engineer will support R&D to identify and evaluate suppliers which comply with product requirements and current / future business needs.  This role will be a key liaison between R&D, Global Quality, and suppliers.   They will lead efforts to drive improvement in the supply chain through identification and selection of suppliers to support development activities and implementation of quality strategies and objectives.  They will partner with Global Quality and Procurement to maintain and improve the Supplier Management System which includes supplier qualifications, supplier audits, supplier corrective action 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 identify suppliers who are capable of meeting product requirements, current business needs, and forecasted business growth.
• Responsible for all aspects of quality of supplied components and assemblies.
• Responsible for driving supplier APQP and, when applicable, PPAP / component and sub assembly qualification process.
• Audit suppliers and contract manufacturers.
• Define, monitor, and manage supplier quality metrics.
• Develop and deploy quality strategy, programs, and roadmap for contract manufacturers and critical suppliers.
• Responsible for developing the Supplier Score Cards.
• Organize with Procurement team in conducting routine QBR of critical suppliers
• Partner with organizational leaders and industry peers and 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 to incoming inspection process.
• Participate in the supplier selection process.
• Partner with Engineering team to recommend solutions to common defects or problems.
• Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
• Provide quality oversight, review, and approve qualification documentation and reports.
• Provide direction and support technical and design review activities as a Quality representative Supplier SME.
• As the point of contact on assigned projects, performs a variety of highly skilled duties such as assembling, coordinating and managing multidisciplinary technical review teams
• Work cross-functionally with individuals and project or 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
• 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

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 40% 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

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.