Foundation Medicine · 4 days ago
Sr. QA Engineer, CAPA
Boston, MA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $125K/yr
5+ years expFoundation Medicine is a biotechnology company focused on advancing cancer care. The Sr QA Engineer (CAPA) is responsible for maintaining and improving quality systems, specifically managing the CAPA process and ensuring compliance with relevant standards. This role requires collaboration across departments to support the effectiveness of the CAPA Quality System.
BiotechnologyGeneticsHealth CareMedical
Responsibilities
Develop and maintain an effective corrective and preventive action program
Monitor CAPA phases and associated due dates to ensure timely progression and closure
Facilitate cross-functional root cause analysis using tools like 5 Whys, Fishbone, and FMEA
Provide technical writing guidance and ensure documentation is compliant with GxP, FDA, CLIA, CAP, ISO 13485, and other applicable standards
Facilitate the CAPA Review Board (CRB), including preparation of materials, coordination of meetings, and documentation of decisions
Monitor CAPA effectiveness and ensure timely follow-up
Support audits and inspections by providing CAPA-related documentation and responses
Collaborate with stakeholders in Operations, R&D, Regulatory Affairs, and Clinical teams
Identify trends and systemic issues through data analysis and recommend process improvements
Assist with reporting Key Performance Indictors (KPIs)
Other duties as assigned
Qualification
Required
Bachelor of Science degree or equivalent years of experience in technical or engineering discipline
3+ years of experience in CAPA management within a regulated environment (biotech, pharma, or diagnostics)
5+ years of related professional experience
Preferred
5+ years of Quality Assurance experience; preferably in the medical device or pharmaceutical industry with CAPA management experience
Strong understanding of quality systems and regulatory requirements (GxP, IVD, FDA, ISO, CLIA, CAP)
Proficiency in quality tools and methodologies (e.g., 8D, DMAIC, Six Sigma)
Excellent communication, documentation, and project management skills
Experience with electronic quality management systems (eQMS)
Understanding of HIPAA and importance of privacy of patient data
Commitment to Foundation Medicine's values: Integrity, Courage, and Passion
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for Foundation Medicine's benefits.
Company
Foundation Medicine
Foundation medicine is a molecular information company developing clinical diagnostic tests that facilitates personalized cancer therapies.
1001-5000 employees
H1B Sponsorship
Foundation Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (41)
2023 (30)
2022 (36)
2021 (41)
2020 (45)
Funding
Current Stage
Public CompanyTotal Funding
$96.5MKey Investors
Kleiner Perkins
2015-01-12Acquired
2013-09-25IPO
2013-01-08Series B· $13.5M
Leadership Team
Daniel Malarek
Chief Executive Officer
David Fabrizio
VP, Commercial Strategy and Medical Innovation
Recent News
2025-12-05
Company data provided by crunchbase