Supplier Quality Engr - West Pharma
Posted April 6, 2021

Job Summary:

This role will perform activities to ensure West suppliers maintain compliance with West’s procedures and policies outlined in the Supplier Quality Management program. The role will work closely with West Medical Device material/component/service suppliers on technical and quality issues

Essential Duties and Responsibilities:
  • Perform activities for the development and implementation of Supplier Owned Quality program
  • Support the development and implementation of strategic monitoring and control of incoming inspection of components.
  • Support the development of digital strategies to enhance supplier performance reporting and ensure consistent actionable data.
  • Work directly with D&T department to automate the tracking and reporting of supplier performance data utilizing Power BI.
  • Support component design reviews and work with suppliers to ensure alignment and supplier process controls
  • Support Supplier nonconformances, customer complaint data acquisition, root cause analysis, corrective action, and complaint handling as required.
  • Maintain approved supplier list and supplier records in accordance with quality processes
  • Conducts scheduled audits of suppliers to assess compliance with requirements; perform follow-up actions to ensure corrective actions are implemented, as necessary.
  • Participate on project teams for supplier selection activities and supplier risk management
  • Communicates quality issues to suppliers, with guidance, and provides assistance to develop corrective actions.
  • Participates in supplier performance reviews and quality review meetings, as needed
  • Participates in the development of measurable KPIs and supplier quality scorecards to track and trend supplier performance
  • Provides guidance to cross-functional teams in applying supplier quality system requirements
  • Participates in the development, implementation, execution, and continual improvement of supplier quality management processes.
  • Summarizes outputs, with guidance, from supplier quality management activities for organizational communication and input into management review.
  • Performs other duties as required

Basic Qualifications:
  • Education: Bachelor’s degree in Engineering or science preferred or equivalent experience in related discipline
  • Experience: Minimum 3 years of quality-related experience
Preferred Knowledge, Skills and Abilities:
  • Experience in regulated industries such as pharmaceutical and medical device.
  • In-depth knowledge of cGMP, cGDP, relevant ISO standards, and medical device requirements (ISO 13485).
  • Experience with SAP systems, Minitab, and Six Sigma
  • Familiarity with document management databases, particularly MasterControl.

Travel Requirements:
  • Must be able to travel up to 20-25% of the time, as needed

Physical & Mental Requirements:
  • Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making. Excellent written and oral communication skills
  • Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of customer visits and business development related activities
  • Extreme attention to detail
  • Ability to work in an office and/or manufacturing environment. May need to stand or sit for extended periods of time
  • Medical component and device manufacturing require strict adherence to standards. Must be able to tolerate fumes and from various manufacturing processes. At times must sit for extended periods of time
  • 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
  • Observe and interpret situations, analyze, and solve problems

Req# 33118
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