Senior Specialist, Supplier Quality

This is a hybrid position (3 days per week) working in our office at Waterford, Ireland. Candidates applying must be residing within a 50-mile commutable distance to the job location.

 

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 you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance. 

Essential Duties and Responsibilities

• Establish and successfully execute supplier management plans which will align to overall business objectives 

• Maintain a strong collaborative partnership with external suppliers and cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs 

Additional Responsibilities

• Monitor supplier performance including incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)   

• Execute Supplier Corrective Action Requests (SCAR) with suppliers, ensuring effective and timely closure 

• Work with suppliers,  R&D, and Sourcing on continuous improvement of supplier performance including supplier change request.  

• Evaluate potential new or future suppliers and support supplier selection process with the cross-functional team 

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers during product development and ensures agreement for manufacturable, cost-effective designs 

• Approves components for use in products by driving Product Approval activities with the suppliers 

• Supports Supplier evaluation, audit management and related records 

• Supports the evaluation and development of Quality Agreements and purchasing specifications with suppliers 

• Support the development of an Incoming Inspection strategy on purchased products 

Education

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

Work Experience

• Bachelor’s degree in engineering or related science 

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry 

• Experience working with suppliers and supplier engagement activities

Preferred Knowledge, Skills and Abilities

• Knowledge of sterilization process is preferred  

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations 

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis 

• Fluent in English  

• Thorough understanding of validation activities and risk management principles and techniques