West Pharma Supplier Quality Specialist m/f/d 

Germany, North Rhine – Westphalia 

218591185

Contract details: Permanent, Full-Time

Start date: asap

Katharina Steffens

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
• 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 on continuous improvement of supplier performance
• Evaluate potential new or future suppliers and supports 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 Production Part Approval activities with the suppliers
• Supports Supplier evaluation, audit management and related records
• Supports the evaluation and development of Quality Agreements with suppliers
• Supports the improvement efforts on internal supplier processes

Qualifications:

• 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
• 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 and German
• Thorough understanding of validation activities and risk management principles and techniques
• Strong problem-solving and critical thinking skills
• Negotiation skills and collaborating with suppliers
• Ability to work under high volume production and fast changing environment
• Willingness to work in a cross-functional team with different time zones