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Supply Quality Assurance Specialist

2 months ago

Charleston, West Virginia, United States MAU Full time
Job Overview

MAU Workforce Solutions is seeking a highly skilled Supply Quality Assurance Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring the quality and compliance of our clients' products.

Key Responsibilities
  • Organize and manage quality audits of raw materials, packaging suppliers, and indirect suppliers for qualification of new ones, and conduct on-going supplier capability assessments by on-site visits to verify their performance.
  • Successfully engage with cross-functional teams such as Operations Engineering, Product Development, and Procurement towards selection and management of suppliers.
  • Identify and lead improvement opportunities to proactively ensure internal and vendor compliance to all applicable internal, domestic, and international quality regulations, including but not limited to ISO 13485 criteria.
  • Lead internal supplier quality engineering efforts and partner with our vendors to reduce risk, improve processes, and reduce waste using the quality improvement tools of process control & monitoring, DOE, risk analysis, problem-solving processes, protocol development, reporting, trend analysis and reaction, capability analysis and measurement system analysis.
  • Partner with the Operations and Supply Chain organizations to define and implement effective Supplier Change Management and Supplier Development practices.
  • Develop and maintain effective Quality Metric performance, and identify and execute activities to enhance purchased product quality, reduce supplied material variances, and resolve decreases in performance.
  • Support Material Review Board and qualification process.
  • Support Change Request & review board.
  • Conduct internal audits and support customers or 3rd parties' audits, on its area of expertise as SME.
  • Perform other related duties as assigned.
Requirements
  • Bachelor's degree in Life Science or Engineering discipline.
  • 2+ years of experience in the medical device, pharmaceutical, or biotechnology industry.
  • Clear and logical thinking with strong organization and communication skills.
  • Ability to prioritize and thrive in a cross-functional, inter-company, and international environment.
  • Team player and self-starter, able to perform with low supervision.
  • A solution-oriented growth mindset coupled with decision-making skills.
  • Excellent written and verbal communication skills in English.
Preferred Qualifications
  • Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485.
  • SAP (Enterprise Resource Planning quality module) will be an advantage.
  • Professional certification, such as Six Sigma, Quality Engineer.
  • ISO 11608 experience.
  • Other language skills as German and Mandarin.