Role Overview
Serve as a key quality leader responsible for designing, deploying, and sustaining a robust, compliant, and scalable Quality Management System (QMS) across the World‑Wide Advanced Diagnostics (ADx) division. Drive standardized and unified quality processes globally, ensuring compliance with FDA QSR, ISO 13485, MDSAP, MDR/IVDR, Japanese PAL, and other applicable global standards. Act as a strategic partner to senior leadership, ensuring quality systems support patient safety, regulatory compliance, and operational excellence across clinical and industrial IVD and medical device applications. Operate with a high level of autonomy, exercising independent judgment to solve complex quality system challenges while aligning resources, budgets, and schedules with ADx strategic goals. Report directly to the Sr. Director, Quality Systems, supporting the ongoing development, implementation, and continuous improvement of the global QMS.
Key Leadership & Accountability Areas
- Function as the Management Representative for the ADx Quality Management System.
- Provide end‑to‑end ownership of: Management Review processes, Audit readiness and inspection management, CAPA effectiveness, Document Control, Training, and Change Control
- Lead, coach, and develop the ADx Quality Systems team, fostering a culture of quality, accountability, and continuous improvement.
- Maintain oversight of global quality metrics and Key Design Goal (KDG) metrics across Advanced Diagnostic Systems.
Quality Systems & Compliance Responsibilities
- Develop, implement, and govern quality information and reporting systems to support regulatory compliance and data‑driven decision‑making.
- Develops and implements quality information reporting systems and administers FDA, ISO 13485, MDSAP, MDR / IVDR and Japanese PAL standards including audits, certification and the Management Review process.
- Ensure consistent and effective deployment of quality system processes globally, including for custom products.
- Stay current on evolving U.S. and international regulations, proactively initiating procedural changes to ensure continued compliance.
Audits, Inspections & Continuous Improvement
- Lead and host external regulatory inspections and audits, ensuring strong pre‑inspection readiness and effective post‑inspection remediation.
- Prepare and manage responses to audit nonconformities, partnering with senior management for review and approval.
- Ensure global quality system audits are planned, executed, and followed up effectively.
- Champion continuous quality improvement through: Strategic use of the CAPA system, Direct involvement in situation analysis, Cross‑functional problem solving
- Responsible for management of Document Control, CAPA, and Training and is ultimately accountable for the adequacy and proper controls of the processes
Change Management, Operations & Budget Oversight
- Design and implement a compliant, efficient change control process, including digital and e‑QMS solutions.
- Develop, manage, and monitor budgets for: Capital expenditures, Operating supplies, Labor and staffing
- Provide data‑driven justification for resource needs and investment requests to senior leadership.
- Communicate project status, compliance progress, risks, and solutions clearly across all applicable ADx functions.
People Leadership & Talent Development
- Carry out full people‑management responsibilities, including: Hiring and onboarding, Coaching and performance management, Promotions, transfers, and compensation actions.
- Drive associate engagement, training, and professional growth within the Quality Systems organization.
- Develop and deliver quality system training programs as needed.
- Partner with other quality leaders to address recurring and systemic issues across the organization.
Required Qualifications
- BS in a related scientific or engineering discipline
- 8 years' experience in Quality, Regulatory, or Operations
- 5 years' experience in medical device industry
- 5 years' experience as a people leader
KNOWLEDGE AND SKILLS:
- Thorough knowledge of quality systems regulations. (ISO; FDA; MDSAP)
- Effective financial management, planning, and organizational skills.
- Demonstrated ability to motivate and manage exempt and non-exempt level Quality Systems personnel.
- Effective analytical, technical, and problem solving skills.
- Effective meeting and presentation skills.
- Ability to perform multiple tasks and prioritize work load
- Effectively manage conflict.
- Ability to work in or direct teams to obtain results
- Ability to organize and supervise people and activities
Preferred Qualifications:
- Professional certification (i.e, CQA, CQE, SQE, CQM, Etc)
