Senior Specialist, Supplier Quality

 

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:

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. Manages the following supplier management tools and processes to ensure compliance to standards and processes; Performance metrics (scorecard), Supplier Corrective Actions, Change Requests, Approved Supplier List, Perform supplier Audits and record Management. They will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance. Other activities may include, but are not limited to, tracking supplier performance, coordinating with West procurement teams on supplier improvement efforts, and driving supplier quality improvement initiatives.

 

Essential Duties and Responsibilities:

• Establish and successfully execute supplier management plans which will align to overall business objectives
• Maintain a strong collaborative partnership with cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs
• Monitor supplier performance including Incoming failures, manufacturing yields and field failures to drive supplier corrective action Reports (SCARs).
• Works with suppliers, design engineers, supplier quality and purchasing to lead failure investigations for supplier quality issues and works on improvements in quality, yields and cost of the product- Continuous Improvement
• Evaluate potential future suppliers and supports supplier selection process with the cross-functional team – Supplier Selection
• Assess potential new suppliers for technical, quality and manufacturing capabilities
• Specification Acceptance/Design-For-Manufacturability (DFM) reviews – 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
• Production Part Approval/Qualification - Approves components for use in products by driving Production Part Approval activities with the suppliers including Gage Repeatability & Reproducibility, Process Capability Analysis , Process Failure Mode Effects Analysis (pFMEA), Control Plans, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), etc.
• Supports Supplier evaluation, audit management and related records
• Supports the evaluation and development of Quality Agreements with suppliers
• Summarizes outputs, with guidance, from supplier quality management activities for organizational communication and input into management review.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Performs other duties as required

 

Basic Qualifications: 

• Bachelor's degree preferably in engineering, preferred disciplines could include mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering; advanced degree preferred.
• Experience: Minimum 5 years of related experience

 

Preferred Knowledge, Skills and Abilities:

• Experience in regulated industry such as pharmaceutical and medical device.
• Strong knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other international regulations
• Familiarity with document management databases, particularly MasterControls and SAP.
• Proven ability to manage multiple priorities,