Full-Time
Senior Quality Systems Engineer
Posted on 3/22/2024
Ultrasensitive biomarker detection technology
Senior
Billerica, MA, USA
- BS/BA degree in Biotechnology, Life Science, Engineering, or equivalent minimally, advanced degree is a plus (M.S. in a Life Science, or equivalent)
- Professional certification is desired (i.e., Six Sigma, ASQ certifications, PMP)
- 5+ years related ISO 13485 Quality Assurance or Quality Systems experience
- In-vitro diagnostic (reagents and instrumentation/software) experience preferred
- Strong understanding of QSR and ISO regulatory requirements is required
- Strong understanding and experience with Design Control requirements is required
- Able to lead cross-functional teams and to work independently, without instruction
- Highly organized and detail oriented
- Strong work ethic and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude is a must.
- Support development and maintenance of Quality Management System planning, policies, processes, procedures, and controls ensuring that performance and quality of Quanterix products and services conform to ISO 9001, ISO 13485 and other applicable regulatory agency guidelines to ensure customer satisfaction
- Support ISO 9001, ISO 13485, IVDR, 21CFR820 and other activities for the development, implementation, monitoring, and improvement of Quanterix quality systems
- Support audits of systems, processes, and products to ensure compliance with regulations and the Quality System including third party and customer audits
- Support the feedback/complaint handling process through maintenance of complaint handling QMS requirements, processes, and procedures, including requirements for test plans, and investigation protocols as applicable
- Analyze, trends and develop QA performance metrics reports
- Coordinate/track/drive closure of QMS audit report responses, CAPAs, deviations, etc. to ensure closure and implementation in a timely manner
- Support the Internal Audit Program by participating in internal audits, and supporting timely resolution of observations and nonconformities
- Write and implement standard operating procedures and work instructions for QA functions
- Develop QMS training and help foster a quality-oriented culture
Quanterix represents a pioneer in the biotechnology industry, providing Simoa technology that utilizes advanced microarray printer and ultrasensitive immunoassay platforms. This technology enables ultra-sensitive biomarker detection, facilitating early disease diagnosis and precise treatment in critical areas such as oncology and neurology. The company’s dedication to advancing healthcare through technological prowess makes it an excellent workplace for professionals passionate about impactful innovation and contributing to significant medical advancements.
Company Stage
IPO
Total Funding
$559.6M
Headquarters
Billerica, Massachusetts
Founded
2007