Noah Medical
Manager, Complaints and Post-Market
San Jose, California
Sponsorship not specifiedDetected 27 days ago
PharmacovigilanceMedical Devices
About the role
- 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.
Responsibilities
- Manage adverse event reporting activities including decision rationale and reporting documentation.
- Manage complaint metrics and analytics including trending and measure against statistical trend limits
- Support risk file updates based on post market data such as complaint rates and new hazards
- Manage complaint handling team activities and provide guidance as needed
- Own CAPA and/or Nonconformances pertaining to complaints and adverse event reporting.
- Prepare SOPs and WIs and gather data as needed to support ISO 13485:2016 clause 8.2.1 Feedback and for OUS regulatory requirements
Company info
- 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
- 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.
- 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
- Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner
- Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file
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This listing is sourced directly from Noah Medical's careers page and normalized into a canonical job model.