You will work with the direction of the Quality Assurance Manager as an integral part of the new Development team in a fast-paced environment to develop and bring to market molecular diagnostic tests for detection of circulating tumor DNA in blood. This team supports the existing commercial test (Colvera TM) and is also responsible for the improvement & development of current and new tests, respectively.
The Quality Design Assurance Engineer is responsible for promoting and driving effective utilization of Design Control and Risk Management processes in support of organizational goals and objectives.
- Conduct must reflect the Company’s values and a commitment to the Code of Conduct ethics and compliance program.
- Other duties as assigned by Supervisor.
- ASQ certification is preferred
- 3+ years of related Quality Engineering experience
- Demonstrated ability to act as Subject Matter Expert related to Design Controls, Device History Files, Master Validation Plans, UFMEAs, DFMEAs and PFMEAs, including experience in development and utilization of design control systems and familiarity with structured phase-gate product development processes.
- Strong Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices
- Demonstrated experience organizing and maintaining large documentation sets.
- Demonstrates strong written and verbal communication skills
- Fosters and enables
- Displays dynamic leadership by being assertive and promoting ideas while building consensus
- Promotes teamwork by working collaboratively and closely with others, internally and externally
- Drives execution of action plans by addressing issues in a transparent and effective way.
- Displays agility and flexibility by quickly adjusting to new information in a fast-changing environment
- Strong collaboration, problem solving and analytical skills
- Professional and team-oriented interpersonal communication skills
- Ability to follow up with task owners to close out open items.
- Highly detail oriented with disciplined and effective time management, scheduling, and organizational skills
- Strong knowledge of and experience in applying data analysis and statistical techniques to product/process design and operational activities
- Must be analytical, flexible, innovative, and self-motivated
- Must have the flexibility in work arrangements to meet departmental goals
- Thrive on opportunity to excel and