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Director, Product Quality

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

As part of the Quality team at Noah Medical, you will be at the center of innovation and compliance in medical robotics. We are a dynamic, data-driven, interdisciplinary team of professionals dedicated to surpassing regulatory standards set by the FDA and international bodies. Our team thrives on overcoming hurdles, driving efficiency into our processes, and implementing robust yet agile quality management systems that fosters innovation ensuring that our products make a meaningful difference in patients’ lives. Join us in our journey as we continue to set new benchmarks, break barriers, and shape the future of medical robotics.

A Day In The Life Of Our Director, Product Quality  

  • Regulatory Compliance: 
    • Ensure compliance to QA/RA and FDA requirements in all areas of Mfg-Ops
    •  Communicate any concerns 
    • Support internal QA/RA, QMS, registrar, FDA, State of CA, and other quality and compliance related audits 
  • Product Acceptance and Release:
    • Ensure manufacturing processes and products consistently meet internal quality standards and regulatory requirements.
    • Lead all aspects related to product acceptance and release activities.
    • Implement and maintain robust quality control measures to uphold a high standard of product quality.
    • Drive improvement in Manf by at least monthly analyzing NCR data and collaborating with extended team and tracking projects as needed
  • DHR, FQC and PMI:
    • Oversea and improve DHR and PMC process 
    • Managing resourcing and timely execution of requirements to Mfg-Ops schedules  
    • Ensure needed Product Quality and No Escape of quality issue from Manufacturing Ops
  • Support, Manager, Standardize and Improve product quality at company owned facilities 
  • Process Validations and Continuous Improvement:
    • Guide and lead the team during the product development phase, emphasizing process validations.
    • Investigate and address nonconformances promptly to promote a culture of continuous improvement.
    • Manage changes in the manufacturing process with a focus on quality, ensuring proper validation and documentation.
  • Quality Oversight and Program Management:
    • Ensure the quality oversight of manufacturing processes, production test methods/specifications, and finished product release activities.
    • Manage and improve the Product Bioburden program, emphasizing the importance of quality at every stage.
    • Partner with manufacturing to ensure appropriate facilities for the production of medical devices are established and maintained.  
    • Collaborate / drive manage effectively, sterilization, contract manufacturers and other suppliers to ensure alignment with quality standards.
    • Collaborate and improve product quality and Mfg OIps
  • Sterility Assurance and Annual Validations:
    • Oversee sterility assurance processes, emphasizing the importance of integrity and sterility in medical devices.
    • Plan, execute, and document annual sterilization validations, reinforcing adherence to regulatory guidelines.
    • Improve overall quality processes associated with Product Quality 
  • Team Leadership and Development:
    • Provide visionary leadership to a team of engineers and quality professionals.
    • Foster a culture of continuous improvement and adherence to quality standards.
    • Actively coach and mentor staff on the principles of quality excellence.
    • Establish strong working relationships to ensure product quality at every stage of the manufacturing process. 
  • Collaboration and Cross-Functional Projects:
    • Collaborate with cross-functional teams on qualification, process capability, and process improvement projects.
    • Encourage a collaborative approach to quality initiatives.
  • Quality Culture Advocacy:
    • Actively champion a quality culture throughout the organization.
    • Provide hands-on guidance and leadership to instill a commitment to quality in all team members.
    • Participate enthusiastically in QE/QMS activities, contributing to the overall quality culture.
  • Other related duties and assignments not indicated above

About You

  • BS in Engineering or Technology, Mechanical, Industrial, Electrical, Manufacturing, Life Sciences, or equivalent.
  • Minimum of 10 years of work experience in the medical device field with at least 5 years of supervisory or management experience. 
  • Experience in production environments that meet world class regulatory requirements such as ISO/FDA Quality Management System requirements. 
  • Management experience in inspection/test method development and validation.
  • Experience with Risk Analysis, FMEAs, Hazard Analysis, GD & T requirements.
  • Experienced with statistical skills to define/train on test sample size and data analysis techniques.
  • Experienced in Microsoft Office and other software tools such as Google Suite, Jama, and ePLM/eQMS systems, or equivalent.
  • Must have attention to details, be a self-starter, a team builder, and excellent in verbal and written communication.
  • Preferred but not required:  experience with Software Validation, with both disposable/sterile devices and capital/electronic equipment. 
  • Certifications: ASQ CQE certifications, 6 Sigma, ISO Auditing, etc., are a plus.

 

#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

$193,000 - $242,000 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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