Quality Assurance Manager || Remote, US-Based

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.

• 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.

• Bachelor’s degree or higher educational experience
• 3-5+ years of experience in quality assurance, preferably within SaaS.
• Proven track record of maintaining compliance with standards like ISO 9001.
• Experience leading audits, process improvement initiatives, and cross-functional quality efforts.
• In-depth knowledge of quality management systems (QMS) and IEC standards.
• Proficiency in quality tools like CAPA, FMEA, risk assessments, and root cause analysis.
• Strong data analysis skills to monitor quality metrics and drive insights.
• Familiarity with software tools used for quality documentation and compliance tracking.
• Strong leadership skills to manage and motivate teams.
• Excellent problem-solving and critical-thinking skills for resolving quality issues.
• Effective communication to collaborate with engineering, product, and regulatory teams.
• Detail-oriented and organized with the ability to manage multiple priorities.

• Learn about the current quality management system and train to all applicable processes and procedures.
• Learn how quality operates at Buoy Software - we’ll help you get accustomed to Buoy’s process, terminology, and other cultural aspects of working here. You’ll shadow team members in meetings.
• Be introduced to the team - we’ll help you start to get to know your colleagues, point of contacts for various scenarios, understanding dynamics within the broader org.
• Go through product demos to start to understand Buoy Software and how it works for both donors experience and donor processing.
• Begin meeting with and getting to know your direct manager.

• Understand goals for the Quality Assurance and Regulatory Affairs department for the next 12 months.
• Understand goals for the product over the next 6 - 12 months.
• Begin to implementing the ISO 9001 Quality Plan

• Complete phases of ISO 9001 Quality Plan
• Meet with stakeholders across the broader Buoy Software organization.
• Become more familiar with the other departments across Buoy Software (including leadership, support, customer success, marketing, and people ops).

• You’ll help build a quality management system that consistently improves its overall performance and provide a sound basis for sustainable development initiatives.
• See your ideas come to life due to our rapid and iterative development process.
• You’ll help the Buoy team build software for good no matter your role. Your work will directly impact the financial health of our members and create better health outcomes for blood-product recipients. Let that sink in.

Qualities that will make you successful at Buoy Software:

Take charge

Own all phases of your projects from discovery to delivery.

Thrive in complexity

Buoy builds products for customers working in a highly regulated industry. Regardless of your role at Buoy, you will play a role in the broader mission of supporting our products providing a better experience to donors, center staff, and customers whether you work in product, support, design, operations, or engineering.

Have a point of view

Hold strong opinions, loosely held. Be willing to present your own thoughts and work together to come to the best solution.

Be collaborative

Work across functions in order to make sure work is feasible, meeting quality standards and delivering value.

Have strong business and technical acumen

Be able to articulate your decisions with logical rationale supported by the needs of the user, business, project requirements and feedback from subject matter experts and teammates.

Embody a can-do attitude

As a startup, sometimes our jobs require us to work outside of our traditional roles in order to get work across the finish line. While your primary role will be in one department/team you may be asked at times to assist with other teams’ tasks necessary to get work completed.

___________

Employment at Buoy Software is contingent upon achievement of satisfactory results on your background check and reference check and your ability to provide proof of your identity and eligibility to accept employment in the United States.

At Buoy Software, we believe in empowering our team to work in a way that suits them best. We offer a fully remote work environment and flexible schedules so you can balance your career and personal life on your terms. Your health and well-being are important to us, which is why we provide comprehensive insurance coverage (medical, vision, dental) to ensure you're taken care of. We also offer a 401(k) program to help you plan for the future, generous parental leave to support you during those important life moments, and a home office stipend to help you create a workspace that inspires productivity and comfort. Join us and be part of a company that values innovation, flexibility, and your overall happiness.