Quality Assurance Senior Specialist

Ideal Candidate: Looking for QA experience (not QC) and 5+ years of QA specific experience. See top 3 skillsets

Does the thought of building an entirely new digital quality management system, excite you.

Do you love to design and streamline processes within a hard-working team. If you have a passion for streamlined, user-friendly Quality Management System enabled by digital and want to be part of s mission to serve patients - every patient every time - then check out this exciting new opportunity. Be part of the Digital Quality Management System, a transformation that will encompass the process redesign, simplification, and sustainment within a new technology ecosystem of advanced analytics and system integrations. When completed, the Digital Quality Management System will be a cornerstone for the Quality End-to-End Transformation delivering a streamline and modernized Quality Management System to handle the increases in product volume and complexity across the enterprise (R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, functional areas and partner groups within the Corporate Quality Management System organization. Under general supervision, provide tactical support activities to Quality Management System Lead.

Specific responsibilities include but are not limited to:

• Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across *** Operations and R&D, to the Digital QMS platform for health and control processes.
• Leads Digital QMS audit & inspection readiness, deviations and change control activities
• Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS Maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations
• Manages and provides oversight of documents / records within the Quality Management System
• Oversight of process key performance indicators and metrics
• Manages external contractors providing services to the Digital QMS
• Working across teams managing priorities

Preferred Qualifications:

• Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards
• Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g. FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601and IEC/EN 62304)
• Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations
• Experience with risk-based Supplier Quality Management process.
• Management of Global Inspection and Audit programs
• Proficient working on multiple projects in a deadline driven environment
• Strong decision making and organization skills with the ability to prioritize multiple business priorities.
• Experience in project management, process improvement and quality system management
• Effective verbal and written communication skills (writing and presentations) in English

About ApTask:
ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-owned company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

Candidate Data Collection Disclaimer:
At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.

If you have any concerns or queries about your personal information, please feel free to contact our compliance team at

Applicant Consent:
By submitting your application, you agree to ApTask's ) Terms of Use and Privacy Policy, and provide your consent to receive SMS and voice call communications regarding employment opportunities that match your resume and qualifications. You understand that your personal information will be used solely for recruitment purposes and that you can withdraw your consent at any time by contacting us at or Message frequency may vary. Msg & data rates may apply.