QA Manager

Spear Bio is a well-funded and rapidly growing start-up company based in Woburn, Massachusetts. We are focused on bringing to market a novel ultrasensitive immunoassay platform capable of utilizing small sample volumes with excellent data quality. Spear Bio is looking for an experienced and motivated Manager to lead our Quality Assurance team. The QA Manager is responsible for maintaining Spear Bio's quality management system (QMS) in alignment with regulatory standards, including ISO 13485:2016 and other relevant guidelines. This role requires coordination across product development, commercial, finance, and lab teams to uphold quality assurance across all products and processes. The position also involves regulatory oversight, including Breakthrough Device Designation and 510k submissions, and plays a key role in fostering a quality-focused culture within the organization. IN ORDER TO APPLY FOR THIS POSITION, CLICK ON THIS LINK: RESPONSIBILTIES: Develop, implement, and manage comprehensive quality assurance programs, policies, and procedures to ensure product quality and regulatory compliance with ISO 13485:2016 and other applicable standards. Lead and oversee the QMS, maintaining design history files, device history records, and document control systems, ensuring accuracy and compliance with regulatory requirements. Ensure consistency and control of all documentation, including Work Instructions, SOPs, and Quality Reference Documents. Coordinate and lead internal and external audits, including hosting regulatory agency and third-party audits, and ensure Spear Bio remains audit-ready and compliant with all regulatory requirements. Manage the complaint handling process, including developing test plans, investigation protocols, conducting root cause analyses, and implementing corrective actions to meet regulatory requirements and maintain customer satisfaction. Track and coordinate corrective actions, preventive actions (CAPAs) and deviations, ensuring timely resolution and verification of corrective measures. Conduct investigations on deviations, out-of-specification (OOS), and out-of-trend (OOT) results, using analytical techniques to resolve and prevent quality issues. Design, compile, and analyze QA performance metrics, identifying trends, and preparing reports for senior management that provide insights and highlight areas for improvement. Conduct inspection readiness activities and support regulatory submissions, including FDA 510(k) and Breakthrough Device Designation applications, working with regulatory agencies to achieve approvals and clearances as needed. Develop and deliver quality-focused training for cross-functional teams to ensure understanding and compliance with QMS and regulatory requirements, and foster a quality-oriented culture across the organization. QUALIFICATIONS: The ideal candidate for this position will have demonstratable in-depth knowledge and understanding of QA and RA functions associated with the manufacturing of immunoassay products including reagents, instrumentation and software, and compliance with ISO 13485:2016. Have 7+ years of quality assurance experience in an analytical laboratory setting, with at least 5 years working with immunoassay products. BS degree in the Life Sciences (Molecular and Cellular Biology, Biochemistry, or a related field). Advanced degree a plus. Excellent documentation, organization, communication, multi-tasking and problem-solving skills. Robust proficiency in managing CAPA processes, complaint handling, and audit management Strong knowledge of QSR, ISO regulatory requirements, and experience with design control, FDA 510(k), and Breakthrough Device Designation submissions. The successful candidate must be prepared to work on site in Woburn, MA >80% of month. IN ORDER TO APPLY FOR THIS POSITION, CLICK ON THIS LINK: We offer competitive compensation, with meaningful stock ownership, strong benefits, and a great work environment. This is an opportunity to enter a high-growth startup company at an early stage. We are recruiting candidates who have demonstrated leadership and excellence throughout their careers and are excited by playing an instrumental role in 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.

Created: 2024-11-03