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Recalls & CAPA Manager

San Jose, California

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

Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together!

A Day In The Life Of Our Recalls & CAPA Manager

  • CAPA management: Develop and maintain the CAPA process to investigate and resolve product, process, or service nonconformities. This includes identifying root causes and implementing corrective actions.
  • Recall management: Manage product recall processes from initiation to completion, ensuring timely and effective communication with regulatory bodies and the public.
  • Cross-functional leadership: Lead and coordinate CAPA / Recalls / Project teams to achieve quality objectives and regulatory compliance.
  • Reporting: Report on quality metrics and CAPA performance to all levels of the organization. 
  • Quality system improvement: 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. 
  • Regulatory compliance: Stay up-to-date on global regulations and industry standards related to complaints, recalls, and quality systems.
  • Collaboration: 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. 

About You

  • Bachelor's degree in an engineering discipline; advanced degree preferred.
  • Minimum of 7 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
  • In-depth knowledge of regulatory requirements, standards, and guidelines (e.g., FDA, CFDA, EU MDR, EMA, ISO).
  • Strong understanding of quality management systems, including GMP, GCP, and ISO standards, e.g. 13485.
  • Experienced in conducting internal audits and hosting 3rd party audits.
  • Good understanding of the medical device design, manufacturing, and field service processes
  • Self-starter, team builder, and excellent in verbal and written communication.
  • Preferred: Experience working in a startup environment as well as larger commercial medical device companies
  • Preferred: Knowledge of sterile/disposable medical device production processes.
  • Certifications are 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

$127,000 - $159,000 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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