• Product Quality Compliance Specialist

    Job Locations US-MA-North Reading
    Posted Date 4 weeks ago(4 weeks ago)
    Job ID
  • ­

    The product Quality Specialist will fulfill a new technical role in the Regulatory and Quality Compliance team to ensure that the TraceLink Life Sciences Cloud and TraceLink software product offerings comply with global regulations (21 CFR 11, Annex 11, 21 CFR 820, 21 CFR 211, ISO 27001, ISO 9001, FDA guidance documents, GAMP5, etc.) and customer requirements.


    Independent reviewer: Perform SDLC review and approval; perform product release management activities; and create, review, approve, and manage Validation documentation in collaboration with Engineering and Product Management.

    Validation activities: Create and deliver IQ and OQ documents to customers, perform and document Tool Qualifications, support product offerings, and identify validation and verification or qualification improvements.


    • Ensure organizational compliance with global regulations, TraceLink QMS processes, and customer requirements.
    • Ensure product and product offerings quality in maintained. Support customer audits or requests for information. Support internal audits and vendor audits.
    • Ensure corrective actions and preventive actions related to compliance with Service Level Agreement terms, Incident Management issues, and customer requests are completed and effective.
    • Ensure compliance with risk management activities and improvements.
    • Contribute to quality metrics and key performance indicator reporting, Quality Plan objectives, and team initiatives.



    • BS in Engineering (systems engineering or software engineering preferred) or scientific discipline.
    • 2-4 years performing SDLC, validation and verification, or Tool Qualification activities.
    • Demonstrated knowledge of global regulations specific to Software Development, Risk Management, and Pharmaceutical or Medical Device or Supply Chain industry (DSCSA, UDI, 21 CFR 11, Annex 11, ISO 13485, 21 CFR 820/211, ISO 14971, MDR, GAMP5, ICH Q9 and Q10) .


    • Familiarity with cloud based software systems qualification, development, requirements authoring, or automated testing. Familiarity with Amazon Web Services platform.
    • Current Lead Auditor certification (ISO 9001:2015, ISO 13485:2016, etc.) or Risk Management certification (ISO 14971: 2007 or 2012).
    • 1-3 years of Supplier/Vendor audit experience.


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