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Quality Control Manager

1 month ago

Reston, Virginia, United States SHL Medical Full time
Job Title: Quality Control Manager

SHL Medical is seeking a highly skilled Quality Control Manager to join our team in North Charleston, SC. As a key member of our Quality Operations team, you will be responsible for ensuring the effectiveness and quality of product tested in our Quality Control (QC) Lab.

Main Responsibilities:

  • Oversee the work of assigned team within the QC Lab, including responsibilities on transfer, projects within manufacturing in collaboration with key stakeholders.
  • Manage project activities with accountability for successful completion of all deliverables to the business.
  • Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross-functional groups.
  • Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards, and guidelines.
  • Lead in the monitoring and publishing of QC Lab metrics for the organization.
  • Facilitate team to ensure laboratory-specific investigations are performed in compliance with quality and regulatory requirements.
  • Provide Quality Operations support in cross-functional workstreams leading to continuous improvement.

Requirements:

  • Bachelor's degree in science or engineering discipline (mechanical, industrial, biomedical, chemical engineering, material/life science) is required.
  • At least 5 years' work experience in a regulated environment (medical devices/diagnostic instrumentation industry, pharmaceutical or biotechnology industry).
  • Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, with integrated/non-integrated testing.
  • cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC.
  • Statistical methods.
  • Attention to detail.

We Offer:

  • Competitive compensation package.
  • Modern working environment with state-of-the-art facilities and technologies.
  • Challenging assignments in a fast-growing and innovative industry.
  • Position in a dynamic, international team of highly skilled professionals.
  • Various opportunities for personal and professional development within a global organization.

Please note that SHL is a drug-free employer. This offer of employment is contingent upon your successful completion of various pre-employment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

Interested in joining SHL Medical and supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents via the Easy Apply button or directly to our HR department.