Title:  Senior 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: 

The Supplier Quality Engineer will manage all quality related aspects of materials used across the business, and suppliers of those materials. This covers the management and, as required, the execution of supplier audits, incoming inspections, non-conformance investigations, supplier monitoring and communication. 

Requirements:

• Must have a third level qualification in Engineering/Quality/Science.
• Must have 2+ years work experience in a Medical Device manufacturing environment.
• A working knowledge of quality systems such as ISO 13485 is essential.  Experience and knowledge of 21 CFR Part  820 and EU GMP is an advantage.
• Ideally have an understanding of plastic process manufacturing.
• Must have an in-depth knowledge of validations and change control management in a Medical Device environment
• Must have a working knowledge of statistics, SPC, and ideally the use of Minitab.
• Must have excellent communication skills both oral and written.
• Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.
• Ideally have a working knowledge of Lean / 6 Sigma tools.

                                       Essential Duties and Responsibilities:

• Functional lead for Supplier approval process in accordance with supplier management process.
• Reporting area of responsibility metrics.
• Provide quality inputs to supplier scorecards / management review.
• Coordinate quality documentation required for determination of critical suppliers, this will involve obtaining input from the engineering team and suppliers for each new component sourced.
• Liaise with suppliers to obtain supplier approval documents.
• Maintain relevant documentation to comply with quality standards and customer requirements.
• Oversight upkeep of supplier files to include supplier qualification documentation, supplier monitoring documentation/links, up to date supplier certificates.
• Interact with suppliers to resolve quality issues through the NC/SCAR process and lead quality improvement initiatives with suppliers / customers
• Manage the return of samples and lots to suppliers as necessary.
• Represent supplier quality on new product and supplier qualification projects.
• Perform and monitor qualification and routine supplier audits as part of the audit team.
• Prepare and negotiate supplier quality agreements where applicable.
• Technical/quality evaluation of new suppliers / new raw material items.
• Inventory control of material awaiting incoming inspection.
• Manage Incoming Inspection department.
• Maintain an up to date approved supplier list.
• Support assessment and implement with Supplier regarding changes.
• Ensure suppliers continue to meet Quality requirements with regard to Supplier Change Request process of the company. Promote Good Manufacturing practices and ensure others adhere to the quality system requirements.
• Oversight of the supplier material related processes including participation on Material Review Board to ensure coordination with suppliers in relation to MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
• Liaising with the Manufacturing/Engineering/Quality and Business Units, in assessing and addressing material quality issues.
• Develop strong, positive and beneficial working relationships and effective information flow with other departments and within the Quality department.
• Lead and manage a high performing team to deliver the defined business goals and objectives.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training and regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Identification and development of talent to include performance management and succession planning (in the West Talent Gateway).
• Coaching / development of reports using development and retention plans as appropriate.
• Responsible for the identification and development of talent, to include performance management, coaching and mentoring for high performance.
• Perform additional duties at the request of the direct supervisor.

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.