What are the responsibilities and job description for the Senior Quality Assurance Specialist position at Aditi Consulting?
Payrate: $35 - $37/hr.
Specific responsibilities include but are not limited to:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
#AditiConsulting
Specific responsibilities include but are not limited to:
- Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across company 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
- Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards
- Ability to converse technically with mechanical, electronic, software, and quality engineers 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
- Experience in supplier quality management
- Audit and inspection management
- Ability to work across multiple groups and stakeholders- experience with strong collaboration
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
#AditiConsulting
Salary : $35 - $37
