Job Description

SUMMARY

The Quality Engineer role will provide hands-on support to Visby's new product introduction and manufacturing transfer. This position will support the manufacturing operations including process validation activities (IQ/OQ/PQ), non-conforming material management. The ideal candidate has Assay reagent technical expertise and 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 Design and 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.
• Unless an employee has been granted an exemption based on a medical disability or based on a sincere religious belief, observance, or practice, full vaccination for COVID-19 and proof of full vaccination is required. As a condition of employment with Visby, please be prepared to show proof of vaccination along with your other required legal documents on your first day of employment.