Director, Quality Assurance and Management Rep.

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

Director of Quality Assurance reports to the CEO. This position is the day to day leader of the Quality function and provides guidance and leadership from Quality and Regulatory 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 such as Regulatory Affairs); must be a self-starter, team builder, and excellent in communication.

A Day In The Life Of Our Director, Quality Assurance and Management Rep.:

• Establishes Quality department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones.
• Involved in developing, modifying 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.
• Leads/Supervises operating budget and employees.
• 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.
• 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 properly documented and revised as necessary to assure 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, supplier qualification, manufacturing, and distribution control.
• 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.
• Serves as the designated Management Representative.
• Other management activities not specified and as assigned.
  
  

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 Quality 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.
• Experience with quality tools such as Risk Analysis, FMEA, GD&T, Process Validation, statistical applications, and data analysis/metric presentation techniques.
• 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.
• Preferred working proficiency in Chinese but not required.
  
  

Workplace Type: Hybrid

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 + use-what-you-need sick days
• 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
  
  

Pay Transparency

The Pay Range for this position is listed. Consistent with applicable laws, an employee's pay within this range is based on a number of factors which include but are not limited to relevant education, skills, job-related knowledge, qualifications, work experience, credentials, and/or geographic location of the posted role. Noah Medical reserves the right to modify this range as needed based on candidate experience level and/or specialized skills. Please note that the aforementioned range is only one component of the position's total compensation package.

California Pay Range

$188,500—$235,600 USD

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.

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