Quality Assurance Engineer
3 hours ago
System One is seeking a Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for ensuring the quality of medical devices by driving design, development, and risk management.
Key Responsibilities:- Collaborate with cross-functional teams to bring medical devices to market.
- Evaluate design and development deliverables to ensure high-quality products meet customer needs.
- Support software development improvements in agile environments while complying with medical device regulations.
- Anticipate roadblocks and provide direction for navigating the quality system.
- Ensure thorough root cause analysis for design changes or validation failures.
- Translate critical design attributes to design outputs.
- Guide major programs and may take on project leadership roles.
- Act as the prime technical contact, coordinating with external teams on significant matters.
- Develop technical specifications and ensure regulatory compliance (FDA).
- Direct phases of complex engineering work, developing new approaches to problems.
- Create new processes impacting multiple disciplines.
- Contribute to business objectives, goals, budgets, and costs.
- Present complex technical information and respond to inquiries.
- Mentor junior engineers and provide cross-functional guidance.
- Consult on broad technical and industry issues.
- Work on complex issues requiring deep analysis and judgment.
- Oversee technicians and junior engineers.
- 8 years of experience, including 3-4 in medical devices (quality for design and development in R&D or quality).
- Bachelor of Science degree or Master of Science degree in Engineering or computer science preferred.
- Strong in design quality for embedded medical device software or software development for devices.
- Understanding of software functionality.
- Experienced in risk management and product development as a development or design quality engineer.
- Hands-on with test method validations; product knowledge required beyond document review.
- Familiar with software development and agile methodologies.
- Knowledge of 21 CFR 820.30, ISO 13485, ISO 14971, and ISO.
- Skilled in technical innovation and leadership in mechanical/chemical engineering, fluids engineering, and cellular biology.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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