Own and manage product DHF content completion, integrity, and regulatory & standards compliance.
Represent Quality for the review and approval for design control activities.
Provide guidance to ensure establishment of product specifications and requirements.
Perform supplier and vendor qualifications. Travel may be required.
Define and lead Risk Management activities from R&D through commercialization.
Accountable for development, execution, and analysis of biocompatibility and shelf-life qualifications.
Accountable for Design Verification and Validation planning & execution.
Provide guidance and best practices for design test and inspection method development.
Support manufacturing process development & qualification.
Support internal & external audits.
Mentor, develop, and lead other team members. Dotted line responsibility for Quality Engineer(s) and QC Technician(s).
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
Additional duties may be identified by functional management based on the current project/business objectives.
B.S. Degree in Engineering of technical field; M.S. preferred.
6+ Years of Quality/Regulatory experience in a medical device regulated industry and demonstrated use of Quality tools/methodologies.
Demonstrated knowledge of QSR (21 CFR 820) / ISO Quality System (ISO 13485), FDA Software guidance of Verification & Validation.
Auditing experience in a FDA regulated Class 2 or 3 medical device environment to QSR CFR Part 820 and ISO 13485 Quality Systems.
Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans.
Six-Sigma and CQE Certification preferred.
Additional Salary Information: Benefits
Competitive salaries and meaningful equity
Unlimited PTO and flexible hours for work/life balance
Health, vision, and dental insurance w/ FSA
Life and long-term disability insurance
401(k) retirement savings plan
Choice of gym membership or commuter benefits
Weekly group lunch and a fully stocked snack kitchen
Your choice of professional equipment and software
Relaxed and collaborative culture
One block from Emeryville BART shuttle stop
Many cafes, bars, and restaurants within 5 min walk
Diassess is a startup striving to transform the way infectious diseases are diagnosed. We are developing a disposable home-use test kit which yields results within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include respiratory diseases and women's health.
Healthcare costs are 18% of USA GDP, 30 million Americans are uninsured, and in some regions of the world, healthcare is nonexistent. Our company is addressing these problems by making medical diagnostics more affordable and accessible. Ideal candidates will share our vision and passion for improving healthcare in America and around the world.