Summary

The Sr. Operations QE role will provide hands-on support to Visby’s manufacturing environment. This position will support the manufacturing operations including process validation activities (IQ/OQ/PQ), non-conforming material management, review and approval of batch records for final products intermediates sub-assemblies and reagents, hands on production line support and other required duties. The ideal candidate has electro-mechanical technical experience in medical device and/or diagnostics with a demonstrated ability to address challenges with creative problem-solving techniques.

Essential Duties

  • Responsible for assuring projects meet customer expectations, and regulatory requirements including FDA Quality System Regulations 21CFR Part 820 and Risk Management per ISO 14971.
  • Serves as a Quality Assurance representative on one or more Operations project teams supporting manufacturing and distribution of product.
  • Applies knowledge in Quality Systems to execute overall project assignments
  • Applies statistical tools to analyze data and identify root cause and problem resolution
  • Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
  • Reviews and approves product documentation, drawings, process and process validation
  • Perform and lead risk assessment and failure mode effect analysis exercises in support of manufacturing process activities
  • Produce technical reports to support product changes or quality assurance investigations.
  • Perform other quality-related duties as assigned.

Education and/or Experience

  • BS in a STEM field required; Molecular Biology, Engineering, or related discipline strongly preferred.
  • Minimum of six years’ experience in a FDA regulated Medical Device industry required; Diagnostics experience preferred.
  • Exceptional problem-solving skills.
  • Understands and can subsequently explain complex quality details to non-experts.
  • Exceptional organizational skills.
  • Knowledge and experience with ERP systems and their applications.
  • Experience with QSR, ISO13485, ISO14971, AQL Sampling Techniques

Other Qualifications 

  • Excellent written and interpersonal communication skills.

Physical Demands

  • Comfortable performing repetitive tasks and/or motions.
  • Must be able to lift a minimum of 10 lbs.

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