Supply Quality Engineer

7 days ago

North Charleston, United States MAU Workforce Solutions Full time

Expand your professional career as a Supply Quality Engineer with MAU at our client, a world-leading medical solutions provider, in North Charleston, SC. As a Supply Quality Engineer, you will support the process transfer, launch, scale-up, manufacture, and post-market of the company’s products to assure its quality high standards, and compliance with applicable requirements, regulations and SOP’s. You will also collaborate with regional and global counterparts to ensure consistency of critical processes. This is a short-term contract (3 – 6 months) with a direct-hire opportunity.


What We Offer:

  • Competitive Pay
  • 1st Shift; Monday – Friday; 8:00 AM – 5:00 PM
  • Major Medical Coverage, including dental and vision
  • Opportunity for advancement


What We’re Looking For:

  • 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:

  • 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
  • Professional certification, such as Six Sigma, Quality Engineer
  • Other language skills as German and Mandarin


What You’ll Do as a Temporary Supply Quality Engineer:

  • 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
  • Identifying and leading 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
  • Leading 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
  • Partnering with the Operations and Supply Chain organizations to define and implement effective Supplier Change Management and Supplier Development practices
  • Developing and maintaining 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
  • Performs other related duties as assigned


MAU Workforce Solutions is an innovative global company with extensive experience providing solutions for success in staffing, recruiting, technology and outsourcing to our clients, employees, and applicants. Headquartered in Augusta, GA since 1973, MAU is a family and minority-owned company offering better processes and better people to create efficiencies and greater profits for our clients. Our relationships with world-class companies, our training programs and our culture of family allow MAU to offer better results, better jobs, and better lives to those who work with us.


All Applicants must submit to background check and drug screening


Disclaimer: This job description is not designed to be a complete list of all duties and responsibilities required of the position


EOE

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