QA-100. Manager/Senior Manager, Quality Assurance Quanterix
THIS JOB HAS EXPIRED Job Code: QA-100
Quanterix is an exciting early stage company whose mission is to commercialize a game-changing instrument platform with a menu of immunoassay products that combines proprietary single-molecule sensitivity, multiplexing, and full automation. This is an opportunity to become part of a rapidly growing company on a trajectory to have a major impact in the life science research and clinical diagnostics arenas. We are seeking a talented and passionate Quality Assurance Manager/Sr Manager to join our team and drive development of the quality function at Quanterix.
In this position, the successful candidate will be responsible for leading the quality assurance function in support of product quality and quality system compliance for a menu of immunoassay products on an automated instrument system. The incumbent will help develop and will own the Quanterix Quality System consistent with international regulations. S/he will manage multiple priorities and interfaces across a variety of stakeholders. This position represents an opportunity to have a major impact on developing the quality function and quality culture at Quanterix. The ideal candidate will also have regulatory experience and will have an opportunity to develop this function. Career progression is likely with the right combination of talent and passion.
Support the Product Development efforts as a member of the Product Development team. Inputs to and/or approves test development, protocols, reports, inspection instructions, Design Reviews, Design History File, etc.
Support ISO 13485, IVDD, CLIA certification processes and compliance to FDA?s QSR by assisting with the development, implementation, monitoring, and improvement of Quanterix quality systems.
Manage/administer audits of systems, processes and products to ensure compliance with regulations and the Quality System. Participates in and/or hosts third party audits.
Monitor the uniformity of the complaint handling process through maintenance of complaint handling requirements, processes, and procedures, including requirements for test plans, and investigation protocols as applicable.
Participate in development of corrective action plans and oversee the corrective action and preventative action (CAPA) program.
Design, compile, analyze, trends and issue QA performance metrics reports.
Coordinate/track/drive closure of audit report responses, CAPAs, deviations. Ensure closure and implementation in a timely manner.
Manage and develop QA staff members; plan and implement QA resources to support R&D, manufacturing, and marketing teams.
Write and implement standard operating procedures and work instructions for QA actions.
Coordinate quality training and help foster a quality-oriented culture.
6+ years related QA and Quality Systems experience.
In-vitro diagnostic (reagents and instrumentation/software) experience preferred.
Regulatory Affairs experience with reagent and instrument products highly desirable.
Strong understanding of QSR and ISO regulatory requirements is required.
Strong understanding and experience with Design Control requirements is required.
Able to lead a group and work independently, without instruction.
ASQ CQE and CQA preferred.
Excellent cross-functional team participation skills.
Highly organized and detail-oriented.
Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software, manufacturing software, database software.
Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation.
Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.
||Lexington, MA |
THIS JOB HAS EXPIRED