Position Title: Quality Assurance Senior Specialist
Work Location: Remote (any time zone; local to Thousand Oaks, CA preferred)
Assignment Duration: 1 Year (Possible Extension)
Work Arrangement: Remote
 
Position Summary
Be part of the Digital Quality Management System (QMS) transformation, encompassing process redesign, simplification, and sustainment within a new technology ecosystem of advanced analytics and system integrations.
This role is ideal for professionals passionate about building a user-friendly, streamlined QMS to support an organization’s mission of serving patients—every patient, every time. The Digital QMS will become a cornerstone for the Quality End-to-End Transformation, enabling a modernized system capable of handling increased product volume and complexity across R&D, Operations, and Global Corporate Operations (GCO).
In this role, you will support the QMS team by providing proactive compliance oversight to processes, functional areas, and partner groups within the Corporate Quality Management System organization. Under general supervision, you will provide tactical support activities to the Quality Management System Lead.
 
Key Responsibilities

• Collaborate on process improvement, transfer, and sustainment of QMS processes across Operations and R&D to the Digital QMS platform for health and control processes.
• Lead Digital QMS audit & inspection readiness, including deviations and change control activities.
• Manage Organizational Change Management (OCM) activities and training deliverables supporting the Digital QMS.
• Maintain knowledge of current systems, tools, methodologies, and terminology; ensure adherence to GxP regulations (GMP, GDP, GCP, GLP & GPvP) and other applicable requirements.
• Manage and provide oversight of documents/records within the Quality Management System.
• Monitor and oversee process key performance indicators (KPIs) and metrics.
• Manage external contractors providing services to the Digital QMS.
• Coordinate across teams and manage priorities effectively.

 
Qualifications & Experience

• Education & Experience:
  • Doctorate degree + 2 years of experience
  • OR Master’s degree + 6 years of experience
  • OR Bachelor’s degree + 8 years of experience
  • OR Associate degree + 10 years of experience
  • OR High School diploma/GED + 12 years of experience
• Strong knowledge and experience in Medical Device Quality System Regulations and standards.
• Experience managing implementation of Quality Management System requirements, product standards, and regulatory requirements, including:
  • FDA CFRs for Biologics and Medical Devices
  • FDA Combination Product Regulation
  • ISO 13485
  • EU Medical Device Directive
  • EN 60601 and IEC/EN 62304
• Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities.
• Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, and governmental regulations.
• Experience with risk-based Supplier Quality Management processes.
• Management of global inspection and audit programs.
• Proficiency in managing multiple projects in a deadline-driven environment.
• Strong decision-making, organizational, and prioritization skills.
• Experience in project management, process improvement, and quality system management.

Effective verbal and written communication skills in English (including presentations). 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 35.00/hr.