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 Quality team is an integral part of ensuring products, services, and processes are of the highest quality and meet customer and regulatory requirements. We are a team of detail-oriented professionals who take pride in meticulously assessing processes, products, and services to identify and rectify issues, ensuring the utmost quality and customer satisfaction. If you share our passion for maintaining the highest standards of quality and are dedicated to making a positive impact, we invite you to consider joining our Quality Assurance Team. Together, we can continue to elevate our organization's quality standards and provide unparalleled value to our customers and stakeholders.
A Day In The Life Of Our Manager, Complaints and Post-Market:
- Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
- Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately
- Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file
- Manage vigilance reporting activities including decision rationale and reporting documentation.
- Submit vigilance reports to regulatory authorities
- Manage complaint metrics and analytics including trending and measure against statistical trend limits
- Schedule post market surveillance reviews and complete post market surveillance reports based on EU MDR requirements and MDCG best practices.
- Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on the EU MDR requirements
- Initiate risk file updates based on post market data such as complaint rates and new hazards
- Review customer inquiries and service reports for potential complaints
- Identify and escalate complaints for potential adverse events and vigilance reporting decisions
- Assist in audits (internal and external). May also conduct internal audits as needed.
- Other QMS activities as assigned
About You:
- At minimum a BS degree in a technical field such as engineering, computer science, or a science related discipline.
- 10+ years of complaint-handling experience in the medical device industry.
- Ability to manage others, their work, and your own multiple competing priorities.
- Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments.
- Working knowledge of EU MDR post-market surveillance requirements.
- Working statistical knowledge as it pertains to trending Intermediate understanding of mechanical and software aspects of medical devices.
Workplace Type: Onsite
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
#LI-Onsite
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.
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.