Director, Quality Assurance and Regulatory Affairs

5 days ago

San Jose, CA, United States Noah Medical Full time
Who We Are

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring 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, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

About The Team

The Director of RA/QA reports to the Head of Quality and Regulatory. This position is the day to day leader of the RA/QA function and provides guidance and leadership from a Regulatory and Quality perspective to the team throughout all stages of product development. We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well); must be a self-starter, team builder, and excellent in communication.

A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs at Noah Medical
  • Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones.
  • Involved in developing, modifying and executing RA/QA related company policies, which affect immediate operation(s) and may also have company-wide effect.
  • Manages the RA/QA department functions through direct reports or subordinates.
  • Regularly interacts 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.
  • Supports defining, training and implementing the quality management system (QMS) at Noah Medical and 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.
  • Coordinates the planning and organization of regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service
  • Manages 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, implements field corrective actions.
  • May serve as the designated Management Representative.
About You
  • Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc.
  • Minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
  • Minimum of 3 years of supervisory experience of multiple exempt level employees.
  • Experience 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 requirements.
  • Experienced in conducting internal and supplier audits and hosting 3rd party audits.
  • Must be a self-starter, team builder, and excellent in verbal and written communication.
  • Preferred: Knowledge of sterile/disposable medical device production processes.
  • Preferred: Master Degree, MBA, experienced with Software Validation,
  • Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.
#LI-Hybrid

Pay Transparency

The Pay Range for this position is listed. 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 work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.

California Pay Range

$201,000-$251,000 USD

Benefits & Perks (For Full Time Employees):
  • Competitive Salary
  • Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
  • Equity & Bonus Program
  • Life Insurance (company paid & supplemental) and Disability insurance
  • Mental health support through medical insurance programs
  • Legal and Pet Insurance
  • 12+ paid holidays, 15-20 days of PTO + sick time
  • Paid parental leave
  • In-office snacks and beverages
  • In-office lunch stipend
  • Learning & Development Opportunities: On-demand online training and book reimbursement
  • Team building and company organized social and celebration events

Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.

Noah Medical is 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.

Please visit our Careers Page to view our latest openings.

NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.

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