Senior Quality Assurance Specialist
2 days ago
Job Summary: We are seeking a highly skilled Digital QMS Expert to join our team at Aditi Consulting. As a key member of our organization, you will be responsible for managing the collaboration on process improvement, transfer, and sustainment of QMS processes across company Operations and R&D. This involves ensuring the Digital QMS platform is up-to-date and compliant with health and control processes.
About the Role: As a Digital QMS Expert, you will lead Digital QMS audit & inspection readiness, deviations, and change control activities. You will also manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS. Additionally, you will maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations.
Key Responsibilities: Manage documents / records within the Quality Management System; oversee process key performance indicators and metrics; manage external contractors providing services to the Digital QMS; working across teams managing priorities.
Requirements: 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.
Top 3 Must Have Skill Sets: Experience in supplier quality management; Audit and inspection management; Ability to work across multiple groups and stakeholders- experience with strong collaboration.
Salary and Benefits: The estimated salary range for this position is $35 - $37 per hour, depending on qualifications, skills, competencies, experience, location, and end client requirements. 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.
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