Noah Medical
Director, Quality Assurance and Regulatory Affairs
Noah Medical, San Jose, California, United States, 95199
Director, Quality Assurance and Regulatory Affairs
San Jose, California Overview
Noah Medical is building the future of medical robotics. The Director of RA/QA leads the RA/QA function across all stages of product development, guiding regulatory and quality strategies and ensuring compliance with US and international requirements. About The Team
The Director of RA/QA reports to the Head of Quality and Regulatory. This role drives department objectives, budgets, and staffing, and provides leadership to ensure quality and regulatory excellence across the organization. The position requires a self-starter, effective communicator, and a team builder with a focus on career growth. A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs
Establishes RA/QA department objectives and budgets; manages staff hiring, assignments, performance feedback, and coaching to meet company milestones. Develops, modifies, and executes RA/QA policies that affect immediate operations and may have company-wide impact. Directs RA/QA department functions through direct reports and cross-functional teams. Collaborates with senior management, suppliers, and customers using strong interpersonal skills to resolve issues and gain alignment. Supports the definition, training, and implementation of the quality management system (QMS) and maintains compliance with regulatory requirements. Coordinates regulatory activities related to design/development, manufacturing, distribution, and service. Manages the reporting and investigation of customer/service complaints, corrective actions, and post-market surveillance; leads field actions if necessary. May serve as the designated Management Representative. About You
Requires a BS (preferred in Engineering or Technology) with focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc. Minimum of 10 years of RA/QA experience in the medical device field (capital equipment and services a plus). Minimum of 3 years of supervisory experience of multiple exempt employees. Experience in a startup environment to meet timelines with NPI and product launch teams. Experience implementing a complete QMS to meet US FDA and ISO requirements. Experience conducting internal and supplier audits and hosting third-party audits. Self-starter, team builder, and excellent in verbal and written communication. Preferred: Knowledge of sterile/disposable medical device production processes. Preferred: Master’s degree or MBA; experience with software validation. Certifications such as CQE, CQA, CQM, Six Sigma, ISO Auditor, etc. are a plus. Pay Transparency The pay range for this position is $201,000 - $251,000 USD. Noah Medical offers a comprehensive benefits package including competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office schedules. Actual pay will be adjusted based on skills, experience, education, and location as permitted by law. Total compensation may include additional incentives. Benefits & Perks (Full-Time): Comprehensive health insurance including Medical, Dental and Vision, plus HSA and FSA options Equity and Bonus Program Life and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, 15-20 days of PTO plus sick time Paid parental leave In-office snacks and beverages Learning and development opportunities: online training and book reimbursement Team-building and company events Noah Medical may offer remote, hybrid, or onsite work arrangements within California depending on the specific team and/or role. Noah Medical is an Equal Opportunity Employer. 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, disability, marital or veteran status, or any other status protected by law. Public disclosure and agency policies: No agencies please. Resumes should be submitted through Noah Medical Talent Acquisition. This posting contains standard application and equal opportunity language as required. Apply for this job
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San Jose, California Overview
Noah Medical is building the future of medical robotics. The Director of RA/QA leads the RA/QA function across all stages of product development, guiding regulatory and quality strategies and ensuring compliance with US and international requirements. About The Team
The Director of RA/QA reports to the Head of Quality and Regulatory. This role drives department objectives, budgets, and staffing, and provides leadership to ensure quality and regulatory excellence across the organization. The position requires a self-starter, effective communicator, and a team builder with a focus on career growth. A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs
Establishes RA/QA department objectives and budgets; manages staff hiring, assignments, performance feedback, and coaching to meet company milestones. Develops, modifies, and executes RA/QA policies that affect immediate operations and may have company-wide impact. Directs RA/QA department functions through direct reports and cross-functional teams. Collaborates with senior management, suppliers, and customers using strong interpersonal skills to resolve issues and gain alignment. Supports the definition, training, and implementation of the quality management system (QMS) and maintains compliance with regulatory requirements. Coordinates regulatory activities related to design/development, manufacturing, distribution, and service. Manages the reporting and investigation of customer/service complaints, corrective actions, and post-market surveillance; leads field actions if necessary. May serve as the designated Management Representative. About You
Requires a BS (preferred in Engineering or Technology) with focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc. Minimum of 10 years of RA/QA experience in the medical device field (capital equipment and services a plus). Minimum of 3 years of supervisory experience of multiple exempt employees. Experience in a startup environment to meet timelines with NPI and product launch teams. Experience implementing a complete QMS to meet US FDA and ISO requirements. Experience conducting internal and supplier audits and hosting third-party audits. Self-starter, team builder, and excellent in verbal and written communication. Preferred: Knowledge of sterile/disposable medical device production processes. Preferred: Master’s degree or MBA; experience with software validation. Certifications such as CQE, CQA, CQM, Six Sigma, ISO Auditor, etc. are a plus. Pay Transparency The pay range for this position is $201,000 - $251,000 USD. Noah Medical offers a comprehensive benefits package including competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office schedules. Actual pay will be adjusted based on skills, experience, education, and location as permitted by law. Total compensation may include additional incentives. Benefits & Perks (Full-Time): Comprehensive health insurance including Medical, Dental and Vision, plus HSA and FSA options Equity and Bonus Program Life and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, 15-20 days of PTO plus sick time Paid parental leave In-office snacks and beverages Learning and development opportunities: online training and book reimbursement Team-building and company events Noah Medical may offer remote, hybrid, or onsite work arrangements within California depending on the specific team and/or role. Noah Medical is an Equal Opportunity Employer. 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, disability, marital or veteran status, or any other status protected by law. Public disclosure and agency policies: No agencies please. Resumes should be submitted through Noah Medical Talent Acquisition. This posting contains standard application and equal opportunity language as required. Apply for this job
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