JOB SUMMARY:

The Senior Manager, Quality Systems is a strategic and operational leader responsible for the oversight, development, and continuous improvement of New World Medical’s Quality Management System (QMS). This role ensures compliance with global regulatory standards while driving enterprise-wide quality initiatives. As a key member of the QA/RA leadership team, the Senior Manager collaborates with executive leadership to align quality strategies with business objectives, enhance organizational readiness, and foster a culture of compliance, accountability, and innovation. The role also serves as a visible champion for quality excellence across the organization, influencing long-term planning, policy development, and digital transformation of quality systems.

KNOWLEDGE, SKILLS AND ABILITIES:

• Expert-level understanding of quality system principles and global regulatory frameworks in the medical device industry.
• Proven ability to lead and develop high-performing teams and influence cross-functional and executive stakeholders.
• Strong strategic thinking, organizational, and communication skills.
• Advanced analytical and problem-solving capabilities with a focus on data-driven decision-making.
• High level of integrity and discretion in managing confidential and sensitive information.
• Effective stakeholder engagement and customer interface skills.
• Experience with QMS software platforms and validation methodologies (e.g., GAMP 5, 21 CFR Part 11 compliance).

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a scientific or engineering discipline required; Master’s degree preferred.
• Minimum of 10 years of experience in Quality Assurance or Regulatory Affairs within a regulated industry, preferably medical devices.
• Minimum of 5 years in a leadership role managing quality systems and teams.
• Demonstrated experience presenting to executive leadership and contributing to strategic planning.
• Experience leading QMS software implementation and validation projects.
• Preferred certifications: ASQ (CQA, CQE, or similar), PMP, or equivalent.

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time.
• Occasionally move about inside the office and travel to and from office buildings to access file cabinets, employee offices, office machinery, etc. This may include, but is not limited to, bending and walking.
• Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
• Ability to listen and speak with employees and vendors. Must be able to exchange accurate information in these situations.
• Occasionally lift up to 25 pounds and transport to other offices. This may be performed with reasonable accommodation.
• View and type on computer screens for long periods of time.
  This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned

• Lead and manage core QMS programs, including full ownership of the Corrective and Preventive Action (CAPA) system, ensuring timely investigation, resolution, and closure of quality issues.
• Oversee the Document Control system, ensuring accurate, compliant, and efficient management of controlled documents, records, and change control processes.
• Maintain and enhance the Training Management System, ensuring training compliance across departments and alignment with regulatory and procedural requirements.
• Lead the selection, validation, and implementation of QMS software solutions, ensuring systems meet business needs, regulatory requirements, and scalability goals.
• Monitor and interpret evolving regulatory standards and industry guidelines (e.g., FDA QSR, ISO 13485, ISO 14971, MDR), and proactively implement updates to the QMS to ensure continued compliance.
• Serve as a key advisor to executive leadership on quality system performance, risk mitigation strategies, and regulatory trends.
• Drive audit readiness and lead internal and external audits, contributing to successful inspections with zero major findings.
• Champion enterprise-wide continuous improvement initiatives that enhance system efficiency, reduce CAPA cycle time, and improve training completion rates.
• Lead cross-functional collaboration with Manufacturing, R&D, Regulatory Affairs, and IT to ensure quality system integration, scalability, and sustainability.
• Direct and support root cause investigations and corrective/preventive actions, achieving measurable reductions in recurring quality issues.
• Provide leadership, coaching, and development to direct reports, improving team engagement, capability, and performance outcomes.
• Represent the Quality function in strategic planning sessions, regulatory inspections, and executive-level forums.
• Influence policy development, long-term quality planning, and organizational decision-making to support business growth and regulatory compliance.
  Requirements: