Quality Engineer / Sr. Quality Engineer

Are you a problem-solver? A collaborator? Ready to tackle the world of infectious diseases? InBios is looking for people who value a sense of community, cooperation and camaraderie with a shared vision of delivering impactful solutions to those affected by infectious diseases. At InBios, your ideas are valued, your voice is heard, your accomplishments are celebrated.
ABOUT INBIOS
InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Founded in 1996 in Seattle, WA, InBios is dedicated to delivering superior quality products that are accurate, easy to use and cost effective. We have a portfolio of more than 25 diagnostic products, as well as an extensive catalog of life science reagents. For more information, visit www.inbios.com.
Our primary location is in the dynamic neighborhood of South Lake Union in a state-of-the-art biotech facility, and our secondary location is in the SODO neighborhood with newly remodeled lab and office space in an historic building next to Lumen Field. We also have a stand-alone storage and office facility that is a short walk from our primary location. InBios offers competitive wages and a rich benefit package that includes medical, dental and vision insurance, 401(k), and performance-based rewards. InBios is committed to work/life balance and provides paid vacation and sick time, including a weeklong, paid shutdown in December.
ABOUT YOU
We are seeking a mindful and diligent individual with proven experience working in positions that require critical thinking, problem solving, and sound judgement. This individual will have a warm and welcoming attitude, excellent organizational and communication skills, and a keen eye for detail. If you enjoy helping others to understand and apply GMP principles, finding pragmatic solutions to compliance challenges in a growing company, and being part of a reliable and dedicated Quality Assurance team, then we encourage you to apply for this position.
Experience and knowledge needed to be successful in this position

• BS in Mechanical, Electrical or Bioengineering or related discipline with 5+ years experience in a GMP manufacturing environment.
• Experience with and working knowledge of cGMP, ISO 13485:2016, IVDR, and GLP quality systems, policies and regulations/guidelines.
• Knowledge of root cause analysis tools to perform thorough NCMR and CAPA investigations.
• Demonstrated knowledge of Validation engineering principles for both hardware and software in the medical device industry.
• Ability to utilize statistical analysis to drive process improvements.
• Strong written and verbal communication skills.
• Excellent knowledge of MS Word and Excel. Experience with databases and electronic documentation systems a plus.

Preferred qualifications

• 3+ years experience in Quality Engineering in medical device industry.
• Familiar with the principles of ELISA, rapid immunoassay, and molecular assay production.
• Expertise with Risk Management (ISO 14971:2019)
• Six Sigma or Lean Certification

Job duties include

• Monitor and improve the robustness of the Quality Management System.
• Author NCMR and CAPA investigations.
• Improve compliance of manufacturing processes, supplier operations, and QMS systems through improvements to process controls, documentation, Six Sigma, or Lean.
• Ensure audit readiness via internal audits and oversight of the manufacturing site.
• Partner with suppliers/contract manufacturers to ensure high quality of product and ensure issues are resolved effectively.
• Support resolution of supplier-related NCMRs, SCARs, and assist with supplier selection, qualification, and reassessment.
• Evaluate manufacturing validation activities to ensure risks have been appropriately evaluated and compliance to applicable regulations/standards has been met.
• Support design transfer of new products to manufacturing.

Work environment information
Position responsibilities include work in a Biosafety Level 2 lab (BSL-2) and a humidity-controlled environment.
Wage/Benefits information
Wage commensurate with industry standard and experience. Benefits include medical, dental, and 401(k).
Consideration for position filled is dependent upon education/experience. In general,

• Quality Engineer: BS with 5+ years relevant experience or MS with 2+ years relevant experience.
• Sr. Quality Engineer: BS with 8+ years relevant experience or MS with 5+ years relevant experience.

Job Type: Full-time