Senior Quality Systems Specialist - Integration

The Senior Quality Systems Specialist is responsible for leading and executing quality system integration activities to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable global medical device regulations. This role focuses on evaluating, harmonizing, and integrating quality system processes, documentation and controls.

• Assess and document current-state quality system processes, procedures, records, roles, responsibilities, and controls across both organizations.
• Perform process mapping and detailed gap assessments across applicable QMS processes, including CAPA, Complaints, Document Control, Training, Audits, Management Review, and other relevant quality system areas.
• Evaluate identified gaps against applicable regulatory requirements, corporate requirements, business needs, and the approved QMS integration strategy.
• Support the definition and documentation of future-state processes, including process ownership, roles, responsibilities, interfaces, and required controls.
• Develop, revise, and harmonize procedures, work instructions, forms, templates, and related quality system documentation to support the approved future-state QMS.
• Partner with process owners and subject matter experts to determine appropriate disposition of existing processes and documentation, including adoption, revision, consolidation, replacement, or retirement.
• Identify compliance risks, process dependencies, implementation constraints, and potential business impacts associated with QMS integration activities.
• Partner cross-functionally with Manufacturing, R&D, Quality, Regulatory, and other business functions to implement sustainable and compliant integrated processes.
• Support verification of QMS changes to confirm that approved requirements have been implemented and that the resulting processes are effective.
• Facilitate document review, approval, issuance, and retirement activities through the applicable electronic document management system.
• Collaborate with the Training Team and process owners to develop and implement training for new or revised procedures, roles, and compliance expectations.
• Support the transition of applicable quality records, controlled documents, and other QMS content into the approved future-state systems and repositories.
• Maintain effective communication with project management, process owners, and key stakeholders regarding decisions, risks, resource needs, and roadblocks.
• Ensure integration activities maintain ongoing compliance with FDA requirements, ISO 13485, MDSAP, EU MDR, and other applicable regulatory and quality system requirements.
• Support integration-related internal and external audits by providing accurate, complete, and retrievable documentation and objective evidence.

• Level 6 qualification required, preferably in a Science, Engineering, Business or related discipline.
• Minimum of 3 years experience in manufacturing environment or equivalent preferred.
• Experience in regulated environment and interaction with regulatory agencies Knowledge Understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Excellent technical writing and documentation skills.
• Strong communication and influencing skills.
• Ability to plan, organize, and implement multiple concurrent tasks.
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
• De…