Job description

The Company

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. Based in Silicon Valley and backed by well-known institutional investors, our incredibly talented team of 100+ engineers, innovators and industry leaders brings years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics & Hansen.

Full Time Salaried Director of Quality Assurance is part of the senior staff reporting to the CEO of Noah. This position is the day-to-day leader of the Quality functions that provides leadership and guidance from these perspectives to the team throughout all stages of product development, commercialization and post market activities. We are looking for someone that is highly motivated in their career growth; this individual must be a self-starter, a team builder, and is excellent in communication.
Responsibilities:

• Establishes Quality department planning and operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to ensure execution of company milestones.
• Developing, modifying, training and executing Quality related company policies, which affect immediate operation(s) and may also have company-wide effect.
• Manages the Quality department functions through direct reports or subordinates. Has full supervision in terms of operating budget and employees.
• As the Management Representative, this position regularly reports to and interacts with senior management to give QMS performance and status. Communicates with other senior staff members, key suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in difficult and sensitive situations.
• Responsible for defining, training and implementing the quality management system (QMS) at Noah Medical and for the ongoing maintenance of the QMS to ensure that the quality system is implemented and revised as necessary to assure effectiveness in meeting business needs and continued compliance with US and International regulatory requirements.
• Coordinates the planning, promotion and organization of quality, regulatory and reliability engineering activities, including Design/Development/NPI, DHF/DMR/DHR documentation control, supplier qualification, manufacturing, and distribution control locally and with international/offshore partners.
• Reporting and investigation of customer/field service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting; and when necessary, implement field corrective actions.
• Other management activities not specified and as assigned.

Requirements:

• Requires a BS in Engineering or Technology in Mechanical, Industrial, Electrical, Life Sciences, or equivalent.
• Minimum of 15 years of Quality related experience with 5 years of experience in the medical device field including 3 years of medical capital equipment and field service/maintenance operations.
• Minimum of 5 years of supervisory experience of multiple exempt level employees.
• Experience in working in a startup environment to meet rigorous timelines with NPI and product launch teams.
• Experienced in implementing a complete QMS system to meet US FDA and ISO/CE requirements.
• Experienced in conducting internal and supplier audits and hosting 3rd party audits.
• Experience with quality tools such as Risk Analysis, FMEA, GD&T, Process Validation, statistical applications, and data analysis/KPI metric presentation techniques.
• Must be a self-starter, team builder, excellent in verbal and written communication.
• Preferred: Knowledge of sterile/disposable medical device production processes.
• Preferred: Master Degree, MBA, experienced with Software Validation, Certifications a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.
• Preferred offshore manufacturing/transfer experience.
• Preferred working proficiency in the Chinese language.

We may also offer hybrid remote/onsite work arrangements within the state of California where applicable. Please visit our Careers page (noahmed.com/careers) to view our latest openings.

Noah Medical is proud to be an Equal Opportunity Employer. We celebrate diversity and 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.

To all recruitment agencies: Noah Medical does not accept unsolicited 3rd party agency resumes. Please do not forward resumes to any Noah Medical employees. Noah Medical is not responsible for any fees related to unsolicited resumes and we will not pay fees to any third-party agency or company that does not have a signed agreement with Noah Medical.

Job Type: Full-time

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