Quality Systems Manager

Elevaris Medical Devices • Wilmington, MA

7h

About The Position

The Quality Systems Manager is responsible for the effective management, improvement and delivery of the key core elements of Elevaris Quality Management System (QMS) across all sites, with specific ownership of the Corrective and Preventive Action (CAPA) process. The role ensures that core elements of QMS remain compliant, effective and proportionate to business needs, while driving timely and sustainable resolution of quality issues. The position will work cross-functionally with Quality, Manufacturing, Engineering, Supply Chain and other functions to strengthen quality systems, improve CAPA effectiveness and deliver QMS improvement projects across multiple Elevaris sites.

Requirements

• BS/BA Degree in Engineering or Biological Science area applicable to medical devices
• 7-10+ years experience in Quality, Engineering, Science, Manufacturing or a related discipline working within a regulated manufacturing environment, preferably medical devices, pharmaceutical, life sciences or another highly regulated industry.
• Working knowledge of ISO 13485, 21 CFR Part 820 / FDA Quality Management System Regulation (QMSR).
• Strong practical knowledge of Quality Management Systems and CAPA.
• Demonstrated experience leading complex investigations and root cause analysis.
• Experience managing cross-functional quality improvement or remediation activities.
• Strong understanding of risk management and quality system principles.
• Experience supporting regulatory, notified body, certification or customer audits.
• Strong project management, facilitation and stakeholder management capability.
• Ability to analyze quality data, identify trends and translate findings into action.

Nice To Haves

• Master’s degree in Business, Health Sciences or Engineering is considered desirable but not required
• Medical device industry experience.
• Working knowledge of applicable international regulatory requirements related to medical devices outside of ISO 13485 or FDA QMSR.
• Experience with electronic QMS platforms.
• Formal training in root cause analysis/problem-solving methodologies such as 5 Why, Fishbone/Ishikawa, fault tree analysis, DMAIC or equivalent.
• Project management, Lean or Six Sigma qualification.
• Experience leading QMS remediation or quality system transformation programs.

Responsibilities

• Own and maintain CAPA system across Elevaris sites, ensuring compliance with applicable regulatory, statutory and corporate requirements are executed within each site’s procedures and provides oversight for CAPA system performance (execution metrics)
• Provide coaching and training for CAPA participants.
• Ensure CAPA processes are clearly defined, appropriately governed and consistently implemented across the sites.
• Identify gaps, risks and opportunities and lead improvement or remediation activities as assigned across CAPA feeder subsystems, such as nonconforming materials, complaint investigations, and internal audits.
• Establish and monitor QMS performance indicators, trends and improvement priorities for applicable systems.
• Coordinate periodic reviews of QMS effectiveness and support Management Review.
• Partner with process owners to ensure quality system processes remain effective and fit for purpose.
• Support inspection and audit readiness and coordinate QMS-related responses and remediation where required.
• Ensure QMS changes are appropriately planned, documented, implemented and sustained.
• Act as the global process owner for the CAPA system.
• Ensure CAPAs are initiated, investigated, documented, approved and closed in accordance with procedural and regulatory requirements.
• Provide governance and oversight of the site CAPA portfolio, including ageing, overdue actions, extensions and effectiveness checks.
• Facilitate or coach teams in structured root cause analysis and problem-solving.
• Challenge weak root cause analysis, inappropriate corrective actions and insufficient objective evidence.
• Ensure corrective actions address systemic causes rather than symptoms.
• Establish appropriate effectiveness criteria and ensure effectiveness checks demonstrate sustainable resolution.
• Monitor and trend CAPA performance and identify recurring or systemic quality issues.
• Escalate significant CAPA risks, delays and recurring issues to site leadership.
• Chair or facilitate CAPA review/governance meetings as appropriate.
• Lead QMS improvement, remediation and transformation projects from definition through implementation and sustainment for CAPA feeder subsystems, such as nonconforming materials, complaint investigations, and internal audits.
• Develop project plans, milestones, deliverables, risks and dependencies for significant QMS initiatives.
• Coordinate cross-functional workstreams and ensure clear ownership of actions and deliverables.
• Simplify and standardize QMS processes where appropriate while maintaining regulatory compliance.
• Support implementation or optimization of electronic QMS tools and workflows.
• Apply risk-based thinking to prioritize QMS improvement activities.
• Ensure improvements are embedded through appropriate procedures, training, metrics and governance.
• Support internal, external, customer and regulatory audits/inspections.
• Define common expectations for internal audit processes across Elevaris sites; execution remains within site control
• Coordinate or support responses to audit and inspection observations relating to the QMS and CAPA.
• Ensure commitments arising from audits, inspections and quality reviews are appropriately captured, tracked and completed.
• Maintain a state of inspection readiness for Audits and CAPA processes.
• Provide QMS and CAPA subject matter expertise during audits and inspections.
• Work closely with Manufacturing, Engineering, Quality, Supply Chain and other functions to improve quality system effectiveness.
• Coach process owners, CAPA owners and investigation teams on QMS requirements and good problem-solving practices.
• Influence stakeholders to deliver quality actions on time without relying solely on formal authority.
• Promote accountability for quality within the functions that own the underlying processes.
• Build capability across the organization in root cause analysis, CAPA and quality systems thinking
• Upholds and role-models company Values of Integrity, Invested, Inclusion and Ingenuity
• Other duties as assigned by management

Benefits

• Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior