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.
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
Excellent written and interpersonal communication skills.