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Quality Assurance Manager || Remote, US-Based
Buoy SoftwareUKRemotefull_timeVerifiedPosted 18 Mar 2025
About the role
About Buoy Software
At Buoy, we are reimagining the blood-product donation and collection experience in an industry that has been largely untouched by advances in technology for decades. It is one of the few remaining verticals that have yet to see the transformative power of modern technology and great design. The result is creating huge impact in three distinct areas: making blood product-derived biotherapies more accessible to patients battling life-threatening conditions, creating employment opportunities and economic support in communities that have limited access to resources and creating real business value by increasing the supply of blood-products in a market with compounding demand.
We have been working alongside Join Parachute (www.joinparachute.com/), our sister company, in the opening of small market donation centers across the country that will create local donation center careers, opportunities to donate blood products, and provide financial compensation for those donations that will have a positive economic impact in those communities. We’ll continue to expand our reach to support other companies who could benefit from the products that Buoy has created and developed.The need for blood products is growing rapidly. We want to close the gap in blood product supply and demand by empowering organizations with the right tools. Buoy is the intuitive, data-driven mobile application for donors.
Why work here?
Because our business focuses on the collection and sale of blood-product in a highly regulated industry, we are uniquely positioned and protected from other competitors or technologies trying to disrupt what we’ve built. Simply put, we have huge opportunity for growth and the only challenge that stands in our way from achieving our goals is our own ability to execute on our strategy. To date, we have been able to successfully deliver and grow and have ambitious plans for our future. If this resonates with you, we hope that you consider joining our team and working towards our mission of unlocking more blood-product supply.
About The Role
The Quality Assurance Manager is responsible for overseeing the implementation and maintenance of the Quality Management System (QMS) to ensure compliance with ISO 9001. The QMS Manager will lead regular audits, facilitate cross-functional collaboration with product, engineering, and cybersecurity teams, and proactively monitor changes for the non-medical device product. The role also includes managing risk assessments, conducting post-market surveillance, and ensuring that the organization continuously improves product quality. The QMS Manager plays a key role in ensuring that all processes and non-medical device products comply with applicable standards and internal best practices.This position will be a fully remote position. We are currently open to considering remote candidates based in the United States.Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
At Buoy, we are reimagining the blood-product donation and collection experience in an industry that has been largely untouched by advances in technology for decades. It is one of the few remaining verticals that have yet to see the transformative power of modern technology and great design. The result is creating huge impact in three distinct areas: making blood product-derived biotherapies more accessible to patients battling life-threatening conditions, creating employment opportunities and economic support in communities that have limited access to resources and creating real business value by increasing the supply of blood-products in a market with compounding demand.
We have been working alongside Join Parachute (www.joinparachute.com/), our sister company, in the opening of small market donation centers across the country that will create local donation center careers, opportunities to donate blood products, and provide financial compensation for those donations that will have a positive economic impact in those communities. We’ll continue to expand our reach to support other companies who could benefit from the products that Buoy has created and developed.The need for blood products is growing rapidly. We want to close the gap in blood product supply and demand by empowering organizations with the right tools. Buoy is the intuitive, data-driven mobile application for donors.
Why work here?
Because our business focuses on the collection and sale of blood-product in a highly regulated industry, we are uniquely positioned and protected from other competitors or technologies trying to disrupt what we’ve built. Simply put, we have huge opportunity for growth and the only challenge that stands in our way from achieving our goals is our own ability to execute on our strategy. To date, we have been able to successfully deliver and grow and have ambitious plans for our future. If this resonates with you, we hope that you consider joining our team and working towards our mission of unlocking more blood-product supply.
About The Role
The Quality Assurance Manager is responsible for overseeing the implementation and maintenance of the Quality Management System (QMS) to ensure compliance with ISO 9001. The QMS Manager will lead regular audits, facilitate cross-functional collaboration with product, engineering, and cybersecurity teams, and proactively monitor changes for the non-medical device product. The role also includes managing risk assessments, conducting post-market surveillance, and ensuring that the organization continuously improves product quality. The QMS Manager plays a key role in ensuring that all processes and non-medical device products comply with applicable standards and internal best practices.This position will be a fully remote position. We are currently open to considering remote candidates based in the United States.Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
What you’ll do as a Quality Assurance Manager:
- Maintain ISO 9001 Compliance:
- Update and modify processes to ensure compliance with ISO 9001.
- Ensure all documentation is accurate, complete, and readily available for regulatory inspections.
- Lead regular internal audits to assess adherence to ISO 9001.
- Streamline the Quality Management System (QMS):
- Collaborate with cross-functional teams to implement process improvements that reduce administrative overhead.
- Ensure that the QMS continues to support compliance while enabling business growth.
- Collaborate with cross-functional teams to ensure product changes comply with the internal processes and ISO 9001 requirements.
- Foster Cross-Functional Collaboration:
- Work closely with the product, engineering, and cybersecurity teams to ensure all products meet requirements from design through release.
- Provide guidance and oversight on quality-related topics, integrating compliance checks at each stage of the development process.
- Support teams in the implementation of quality controls and ensure regulatory standards are met.
- Risk Management and Post-Market Surveillance:
- Support risk management practices across the product lifecycle.
- Coordinate with product development and customer support to track post-market product performance.
- Analyze feedback, including complaints, non-conformances, and field data, to drive continuous improvement and ensure the product’s ongoing compliance.
What we are looking for in Quality Assurance Manager candidates:
- Bachelor’s degree or higher educational experience
- 3-5+ years of experience in quality assurance, preferably within SaaS.<
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