Job Title: Quality Systems Manager
Reports to: VP Regulatory Affairs
Location: Boston, MA
The Quality System Manager will be responsible for developing and maintaining our Quality Management System for Biofourmis Inc. The role is based out of our Boston office, but will also involve collaborating with our Singapore office. Biofourmis develops software as a medical device (SaMD) products that we believe will change healthcare. This role is key in ensuring that our products are built with the highest quality, are validated in the appropriate clinical setting, and that our Quality System ensures a continued excellence and commitment to our customers and their patients.
· Developing and maintaining all aspects of our Quality System to be compliant with 21 CFR 820, while still allowing for rapid product development iterations and facilitating modern software development best practices.
· Conducting internal audits, hosting external audits (ex. from FDA) and resolving findings in a timely manner, all in conjunction with a cross-functional team, and advising internal business stakeholders on risk and compliance requirements.
· Ensuring the product development, verification and validation, and risk management activities of development teams, key partner organizations, and other service vendors meet industry standards and internal SOPs, to deliver world class software products to our customers and their patients.
· Ensuring clinical trial documentation is maintained within the organization in accordance with regulatory standards.
· Ensure product development documentation is maintained within the organization in accordance with regulatory standards.3
· Minimum 5 years' experience in a medical device compliance related role.
· Strong knowledge of QMS standards, especially 21 CFR 820, ISO 13485.
· Strong knowledge of industry privacy standard, such as HIPAA, GDPR, etc., and a solid understanding of FDA cybersecurity guidance documents.
· Strong knowledge of medical device engineering standards related to software development, risk management, usability engineering, verification and validation, etc.
· ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) is preferred.
· Experience with Software as a Service (SaaS) and cloud computing is preferred.
· Experience with wearable technology is preferred.
· Experience with clinical trials of non-significant risk medical devices is preferred.
Job Type: Full-time
Salary: $110,000.00 to $120,000.00 /year
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- Retirement plan
This Job Is Ideal for Someone Who Is:
- Dependable -- more reliable than spontaneous
- Detail-oriented -- would rather focus on the details of work than the bigger picture
- Innovative -- prefers working in unconventional ways or on tasks that require creativity
- Achievement-oriented -- enjoys taking on challenges, even if they might fail
- People-oriented -- enjoys interacting with people and working on group projects
This Company Describes Its Culture as:
- Team-oriented -- cooperative and collaborative
- Outcome-oriented -- results-focused with strong performance culture
- Innovative -- innovative and risk-taking
- People-oriented -- supportive and fairness-focused
- Detail-oriented -- quality and precision-focused