Director of Quality Assurance and Management Representative
4 weeks ago
Noah Medical is seeking a highly skilled and experienced Director of Quality Assurance and Management to join our team. As a key member of our leadership team, you will be responsible for leading the Quality function and providing guidance and leadership from a Quality and Regulatory perspective to the team throughout all stages of product development.
This is a unique opportunity to join a dynamic and innovative company that is revolutionizing the medical robotics industry. Our team is passionate about delivering high-quality products and services, and we are looking for someone who shares our commitment to excellence.
Key Responsibilities- Establish and lead the Quality department operational objectives and budgets
- Manage staff hiring, assignments, performance feedback, and coaching to support company milestones
- Develop, modify, and execute Quality-related company policies
- Manage the Quality department functions through direct reports or subordinates
- Lead and supervise operating budget and employees
- Regularly interact with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve, and gain acceptance of others in sensitive situations
- Define, train, and implement the quality management system (QMS) at Noah Medical and for the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements
- Coordinate the planning, promotion, and organization of quality, regulatory, and reliability engineering activities, including Design/Development/NPI, DHF/DMR/DHR documentation, supplier qualification, manufacturing, and distribution control
- Manage the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting, and, if necessary, implement field corrective actions
- Serve as the designated Management Representative
We are looking for a highly motivated and experienced professional with a strong background in Quality Assurance and Management. The ideal candidate will have a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc. and a minimum of 10 years of Quality-related experience in the medical device field. The candidate should also have a minimum of 3 years of supervisory experience of multiple exempt-level employees.
The successful candidate will be a self-starter, team builder, and excellent in verbal and written communication. Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams is a plus. Knowledge of sterile/disposable medical device production processes and certifications such as CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc. are also desirable.
What We OfferNoah Medical offers a competitive salary, comprehensive health insurance, equity and bonus program, life insurance, disability insurance, mental health support, legal and pet insurance, 12+ paid holidays, 15-20 days of PTO, use-what-you-need sick days, paid parental leave, in-office snacks and beverages, in-office lunch stipend, and learning and development opportunities.
We are an equal opportunity employer and celebrate diversity. We are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
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San Carlos, California, United States Noah Medical Full timeAbout the RoleNoah Medical is a leading medical robotics company that is revolutionizing the field of robotic surgery. We are seeking an exceptional Director of Quality Assurance and Management Representative to join our team.This is a critical leadership role that will be responsible for establishing and maintaining our quality management system, ensuring...
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