Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are disrupting the blood testing industry by developing an automated, benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic.
We are looking for a Sr. Quality Engineer, working with Engineering, Supply Chain, Manufacturing Operations, and other Quality resources to support Quality Systems, Process Validation and Investigations. The ideal candidate will have extensive knowledge and experience with SO 13485, 21CFR Part 820, and other applicable external regulations and work collaboratively with cross-functional teams to identify and implement best practice processes, tools, and training for organizational learning and growth.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead the product development team through the risk analysis process including product hazard analysis, DFMEA, PFME, risk benefit analysis, and risk management planning and reporting supporting compliance with ISO14971
- Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques
- Ensure compliance with all relevant FDA 21 CFR 820, Design Control, Risk Management ISO 14971, ISO 13485 regulatory requirements, and internal Quality Standards for product development and manufacturing. Creates and applies policies and procedures for identifying, analyzing and controlling risk throughout the product life cycle
- Resolve QI and CAPA by performing investigations, conducting root cause analysis, developing and implementing plans to resolve and preventative action.
- Designs and installs quality process sampling systems, procedures and statistical techniques
- Participate in development, review and approval of product requirements, product specifications, test protocols and reports
- Design, review and approve verification and process validation, equipment qualification documents.
- Interact with component suppliers on product development projects and quality issues
- Lead and participate on internal and external audit teams
- Conduct capability studies for production processes
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of IVD product.
- Lead as a subject matter expert in Design Control, Risk Management, Design Verification, Design Validation, Process Validation
- Bachelor's degree in field of Science such as Chemistry, Microbiology, Biology, Biochemistry or Engineering, and minimum 8 years of experience; OR Master's degree and 5 or more years of relevant experience:
- Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.
- Hands on Design Verification, Design Validation/Process Validation
- Hands on CAPA System, Non-conformity System, Root Cause investigation and manufacturing process improvement experience
- Process, QMS or Supplier auditing experience
- Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor
- Experience in Quality System Requirements
- Experience with EQMS and ERP
- Risk analysis technique, FMEA, Fault tree, and Hazard Analysis
- Ability to problem solve, handle and resolve conflicts
- Demonstrated ability to lead fast track investigations through analysis to outcomes for decision
- Demonstrated ability to be flexible and resourceful while working under tight deadlines
- Good communication and diplomacy skills required
- Excellent written and verbal communication skills