Senior Quality Assurance Engineer

Spear Bio, founded in 2021, is a well-funded and rapidly growing start-up headquartered in Woburn, Massachusetts. Our proprietary technology, Successive Proximity Extension Amplification Reaction (SPEAR) , is a novel wash-free immunoassay platform, offering unprecedented sensitivity. We are dedicated to revolutionizing early disease diagnosis and monitoring by providing scalable, ultrasensitive solutions that deliver unparalleled accuracy in measuring low-abundant biomarkers, enabling clinicians and researchers to improve patient outcomes and advance global health.

Senior Quality Assurance Engineer:

The Senior Quality Assurance Engineer is responsible for maintaining and advancing Spear Bio’s quality management system (QMS) to align with regulatory standards such as ISO 13485:2016 and other applicable guidelines. This high-growth role offers the opportunity to develop into a Quality Manager position, making it ideal for candidates seeking to expand their leadership responsibilities while driving quality assurance excellence across all products and processes. The position plays a key role in fostering a quality-focused culture within the organization.

Responsibilities:

• Develop, implement, and manage quality assurance programs, policies, and procedures to ensure compliance with ISO 13485:2016 and other regulatory standards.

• Support and maintain the QMS, including design history files, device history records, and document control systems, ensuring accuracy and compliance.

• Ensure consistency and control of all quality documentation, including Work Instructions, SOPs, and Quality Reference Documents.

• Assist with internal and external audits, including hosting third-party and regulatory audits, to ensure the organization is audit-ready and compliant.

• Participate in complaint handling processes, including the development of test plans, investigation protocols, root cause analyses, and corrective actions.

• Track corrective and preventive actions (CAPAs) and deviations, ensuring timely resolution and effective implementation of corrective measures.

• Conduct investigations into deviations, out-of-specification (OOS), and out-of-trend (OOT) results, utilizing analytical techniques to resolve and prevent quality issues.

• Compile and analyze QA performance metrics, identifying trends and preparing reports to inform senior management of insights and improvement opportunities.

• Provide quality-focused training to cross-functional teams, promoting compliance with QMS and regulatory requirements and fostering a quality-oriented culture.

Qualifications:

• 4+ years of quality assurance experience in diagnostic or bioassay company, with a solid understanding of immunoassay products including reagents, instrumentation, and software, while ensuring compliance with ISO 13485:2016.

• A bachelor’s degree in Life Sciences (e.g., Molecular and Cellular Biology, Biochemistry, or a related field). Advanced degree or equivalent experience is a plus.

• Strong documentation, organization, communication, multitasking, and problem-solving skills.

• Proven experience in managing CAPA processes, complaint handling, and audit participation or management.

• This position is located on site in Woburn, MA, in-person 5 days/week.

We offer competitive compensation, meaningful stock ownership, comprehensive benefits, and a great work environment. This is an opportunity to enter an innovative, high-growth startup at an early stage. We are focused on identifying candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of building an industry-leading company.

Spear Bio Inc. provides equal opportunity in employment to all persons. No person shall be denied equal access because of race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability.

Spear Bio does not accept blind resume submissions from external recruiting agencies. Any unsolicited resumes or candidate information submitted without prior written agreement will be deemed the property of Spear Bio, and no placement fees will be paid.