Quality Assurance Specialist

2 weeks ago


Cambridge, Massachusetts, United States SPECTRAFORCE Full time

Job Title: Quality Assurance Specialist - Quality Systems

Location: Remote

Duration: Contract Position

This position is a hybrid role with scheduled work hours Monday to Friday, 8:30 AM to 5:00 PM, requiring onsite presence based on project needs.

Key Responsibilities:

The Quality Assurance Specialist operates within the Quality Systems division and collaborates with diverse teams across the organization. This role is essential in ensuring that the Quality Management System, Corrective and Preventative Actions (CAPA), and Non-conformance processes are efficient and compliant. The Specialist will assist Quality team members in achieving all relevant business objectives.

• Support the Quality Management System initiatives.


• Aid in the continuous improvement and standardization of the quality system across various locations.


• Collaborate effectively across departments to ensure timely completion of documentation.


• Maintain Quality Management Systems for the designated area, including Design Controls, Software Development, Risk Management, CAPA systems, and Non-Conforming Material Reports.


• Assist in root cause analysis and the implementation of corrective and preventative actions, ensuring effectiveness is verified as required.


• Responsible for the development, measurement, and monitoring of key performance indicators.


• Perform additional duties as assigned.

Preferred Qualifications:


• Bachelor’s Degree in a relevant field such as Sciences, Engineering, or Business.


• Experience with In Vitro Diagnostic (IVD) or Medical Device Quality Systems.


• Familiarity with industry standards and regulations related to IVD and/or Medical Devices, including FDA QSR 820, ISO 13485, ISO 15189, CAP/CLIA, and IVD/IVDR.


• Understanding of CAPA and Root Cause Analysis methodologies.


• Knowledge of Good Manufacturing Practices (GMP).


• Strong communication skills with the ability to influence and engage effectively regarding quality system processes.


• Capacity to thrive in a fast-paced environment with meticulous attention to detail.


• Proficiency in Microsoft Office Suite, including Word, Excel, Project, and PowerPoint.


• Excellent interpersonal skills and ability to work collaboratively within a multidisciplinary team.


• Awareness of HIPAA regulations and the significance of patient data privacy.


• Commitment to values such as patient care, innovation, collaboration, and passion.

Basic Qualifications:


• Bachelor’s Degree; OR,


• 5+ years of relevant experience in a similar role.



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