Sr Quality Manager - CAPA

PURPOSE AND SCOPE:

The Sr. Manager, CAPA , is responsible for driving overall CAPA management including CAPA process, system improvements, standardization, harmonization, and CAPA transformation across QMSR North America sites (FMCNA), with a primary focus on improving how CAPA is managed in line with NA and global QMSR, Global Management Systems (GMS), and associated operational and business systems.

The Sr. Manager leads, engages, demonstrates, advises, and changes CAPA process to demonstrate effective systems and in compliance with all regulatory and quality requirements – while meeting business objectives and performance expectations.  This role focuses on simplification and improving the ways we work both locally and globally. In addition, this role focuses on how regulatory and business processes/systems are working in synch to ensure delivery of effective CAPA solutions to advance the cause of quality and business objectives.

The position is responsible for leading the CAPA process, program, and activities across the organization to ensure compliance with global regulatory requirements including FDA Quality System Regulation / QMSR, ISO 13485, and applicable international standards. This role drives, facilitates, coordinates and escalates as appropriate the investigation and resolution of complex quality issues arising from complaints, nonconformances, audit observations, supplier issues, and post-market surveillance activities related to medical devices and drugs including device-drug combination products as well as digital products. The Sr. CAPA Manager partners closely with cross-functional teams including Engineering, Manufacturing, R&D, Clinical, Regulatory Affairs, and Supplier Quality to ensure timely execution of robust root cause investigations and sustainable corrective actions. The role also supports regulatory inspections, notified body audits, and global compliance initiatives while continuously improving the effectiveness of the CAPA system.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

·         Leads and manages the CAPA program and process in accordance with 21 CFR 820 / FDA QMSR, ISO 13485, and global regulatory requirements.

·         Provides regular updates to appropriate levels of management regarding overall CAPA performance.

·         Ensures proper investigation, documentation, and closure of CAPAs, Nonconformances, and Quality Events.

·         Monitors CAPA timelines and effectiveness checks to ensure compliance and sustainability of corrective actions.

·         Ensures CAPAs are properly linked to appropriate complaints, audits, risk management files, and supplier quality events.

- Drives process improvements and changes by working collaboratively with leaders, employees, and all stakeholders.
- Evaluates and drives changes on CAPA SOPs, policies, and procedures for measurable improvements.
- Collaborates with employees to drive CAPA education and training of process requirements, improvements, and application.
- Collaborates with employees to address CAPA areas of improvement and speed up the overall performance and execution.

·         Leads complex root cause investigations using structured methodologies such as: 8D problem solving, Fishbone (Ishikawa),5 Whys, Fault Tree Analysis, DMAIC and using other tools

·         Participates and supports FDA inspections, Notified Body audits, and internal quality audits related to CAPA system effectiveness.

·         Prepares CAPA documentation and investigation records for regulatory review.

·         Addresses audit observations and drive timely completion of corrective actions.

·         Ensures investigations are data-driven, well documented, and meet regulatory expectations.

·         Identifies systemic issues through data analysis and trend monitoring.

·         Develops improvements to strengthen the CAPA process and overall quality system.

·         Drives continuous improvement initiatives across manufacturing and quality processes.

·         Trains cross-functional teams on CAPA process and root cause investigation methodologies.

·         Mentors investigators and ensure high-quality CAPA documentation.

·         Promotes a strong quality and compliance culture across the organization.

·         Effectively manages multiple CAPAs simultaneously while ensuring excellent communication, documentation and investigation skills.

·         Able to manage and address CAPAs that may go beyond one site or one specific area/region/function.

Leadership & Collaboration

·         Leads CAPA team with strong leadership and capabilities including ‘know-how’.

·         Influences and partners with other functional leaders.

·         Facilitates cross-functional and cross-regional CAPA alignment and drive solutions.

·         Teaches, educates, coaches and advises on CAPA process excellence and continuous improvement.

Management Controls & Governance

·         Partners with Quality leadership to establish governance structures.

·         Develops KPIs/dashboards and reporting mechanisms for leadership review and decision-making.

·         Ensures clear accountability, escalation paths, and decision criteria are embedded in quality processes.

·         Hands-on experience managing CAPAs, Nonconformances, and Root Cause Investigations.

·         Experience with Class I, II and Class III medical devices.

·         Proven experience leading complex investigations across multiple functions.

CAPA Management Process Excellence

·         Partners with local and global CAPA teams, Quality teams, and operational leaders to evaluate current-state CAPA processes and identify opportunities for improvement to ensure they are efficient, risk-based, and effective.

·         Participates in identifying best practices for CAPA management.

·         Defines and monitors CAPA process performance in collaboration with functional owners.

·         Facilitates cross-functional forums to address systemic CAPA issues and recurring trends.

·         Engages in and support regulatory inspections including in readiness activities.

PHYSICAL DEMANDS AND WORKING CONDITIONS :

·      Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

- The employee is occasionally required to lift or move up to 25 pounds.
- The work environment is similar to that of any medical device / drug manufacturer and would have no impact on the employee to perform the essential functions of this job.

EDUCATION:

·         Bachelor’s degree required (Science, Engineering, or related field).

·         Professional quality discipline certification is a plus (e.g., CQE, CQA).

·         Master’s degree preferred.

EXPERIENCE AND REQUIRED SKILLS :

·         10+ years of experience in CAPA, Quality, or Quality Systems in medical device.

·         Deep experience with QMSR processes, governance, and performance improvement.

·         Demonstrated success leading process transformation through influence, not direct ownership.

·         Strong experience working with QMSR and Quality leaders.

·         Experience supporting regulatory inspections and audits.

·         Knowledgeable about standards and regulations such as ISO 13485, ISO 14971, 21 CFR QSR Part 820, Health Canada, Brazil, China FDA/NMPA, US FDA QMSR.

Skills and Competencies

·         Expert understanding of QMS and CAPA.

·         Process design, facilitation, and change management expertise.

·         Ability to influence senior stakeholders and drive alignment.

·         Data-driven approach to performance measurement and improvement.

·         Excellent communication and executive presentation skills.

·         Experience with electronic QMS systems (TrackWise, MasterControl, Veeva, etc.).

Key Success Indicators

·         Improved CAPA process efficiency, timeliness, and effectiveness metrics.

·         Reduced recurrence of systemic quality issues.

·         Simplified, standardized, and well-adopted CAPA processes.

·         Positive inspection and audit outcomes related to process robustness.

·         Strong partnership and credibility with functional leaders and employees.

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Rate: $XX - $XX

Non-Bonus Eligible Positions: include language below.

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.

Bonus Eligible Positions – include language below.

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance
Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors