Senior Engineer/Manager, Quality Assurance

Job Description

Job Description

Salary : About Spear Bio :

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 anovel 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.

We are looking to hire an individual with hands-on experience to be responsible for Spear Bio's Quality Assurance program, and are open to hiring either a seasoned Senior QA Engineer or QA Manager . The qualified individual will be responsible for maintaining and advancing Spear Bios quality management system (QMS) to align with regulatory standards such as ISO 13485 : 2016 and other applicable guidelines. This is a high-growth role, making it ideal for ambitious candidates who want to take on more senior leadership responsibilities while driving quality assurance excellence across all products and processes. This position plays a key role in fostering a quality-focused culture within the organization.

CLICK ON THIS LINK TO APPLY : https : / / spearbio.bamboohr.com / careers / 52

RESPONSIBILTIES :

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 :

5-8 years of experience building or enhancing a quality assurance program / platform at adiagnostic or bioassay company, with a solid understanding of immunoassay products.

CLICK ON THIS LINK TO APPLY : https : / / spearbio.bamboohr.com / careers / 52

We offer competitive compensation, with meaningful stock ownership, strong 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.