Senior Specialist, Supplier Quality

  • Waterford
  • West Pharmaceutical Services
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, drive projects to completion and meet internal customer expectations Superb ability to effectively communicate with co-workers and business partners at all levels of the organization (both internal and external). Excellent organizational skills with an ability to think proactively and prioritize work. Working knowledge of statistical data analysis Thorough understanding of validation activities and risk management principles and techniques Strong problem-solving and critical thinking skills Medical industry or highly regulated industry Project Management experience Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making. Excellent written and oral communication skills Medical component and device manufacturing require strict adherence to standards. Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams Read and interpret data, information, and documents Must maintain the ability to work well with others in a variety of situations Must be able to multi-task, work under time constraints, problem solve, and prioritize Ability to make independent and sound judgments Demonstrates enthusiasm, takes accountability, and drives for results. Travel Requirements: Must be able to travel up to 15-20% of the time West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.