Sr CAPA Engineer

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ADDENDUM:

GMS CAPA Office Focus

• Responsible for development of an appropriate strategy to implement all necessary requirements from FME Quality Management and formerly used NC/CAPA tools into one global electronic NC/CAPA tool.
• Assists global NC/CAPA process owner with process definition, documentation, implementation, and maintenance.
• Monitors process as well as tool performance to eliminate deviation and improve efficiency.
• Ensures the GMS NC/CAPA process fulfills applicable regulatory and business requirements.
• Assist process owner to develop strategy to implement a harmonized FME NC/CAPA process and tool integration of all requirements from CQMS, IMS, and NA quality management systems
• Conduct process design & development, document creation, review and assessment, change initiation, user training, and global implementation in accordance with an established project plan
• Generate training materials and provide training to SMEs or key users in all applicable user groups
• Support global rollout of any new or revised NC/CAPA solutions (process enhancement, tools, techniques, etc.)
• Design overviews and dashboards based on defined KPIs and monitor metrics to ensure full transparency of ongoing NC/CAPA activities
• Generate QDATA reports and assess performance trending
• Make a judgment based on the trend and take timely actions to ensure the compliance of the process and the correctness of the user's use
• Ensure existing deviations and penitential nonconformities related to process and electronic tool are recognized and eliminated in a timely manner
• Develop strategy to improve process and tool effectiveness while controlling new risks brought to the process or business

EXPERIENCE AND REQUIRED SKILLS:         

• Experience participating in health authority and/or Notified Body inspections is preferred
• Availability to work different time zones as per business need.

PURPOSE AND SCOPE:

The Senior Engineer, CAPA is responsible for coaching CAPA Engineers to ensure CAPAs (corrective and preventive action) and Non-Conformance (NC) investigations are executed in compliance with company procedures and FDA Regulations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

• Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality Systems personnel and responsible for driving continuous improvement on effective CAPAs as a core Quality Business process/function(s).
• Responsible for assigned CAPAs and will act as CAPA lead to CAPA Owner/Team providing project direction throughout CAPA stages. Performs Quality Approver functions for CAPA and NCs to ensure compliance to applicable procedures.
• Applies sound, systematic problem-solving methodologies in identifying root cause, corrective action(s) and monitoring plan(s) for resolution of CAPA and NC issues.
• Applies technical/compliance information to guide and influence CAPA/NC/Compliance strategies.
• Ensures compliance to requirements and consistency/quality of CAPA and NC execution.
• Drives timely execution of CAPA and NC deliverables through monitoring and reporting status to CAPA Review Board and management.
• Supports the rollout of any new CAPA solutions (tools, techniques, and/or process enhancements).
• Interfaces with management and peers to assess and improve the adequacy of the processes. This includes but is not limited to the remediation of CAPA and NC deficiencies noted in audits and/or inspections. Provide support/responses during audits/inspections relating to the CAPA and NC system as required.
• Develops and delivers CAPA and NC process training as required to ensure the appropriate level of the process knowledge is maintained. Remain conversant with the appropriate regulations, laws and standards to maintain CAPA and NC process compliance and provide up to date guidance and training. Ensure effective CAPA and NC data analysis and investigation, and evaluate their trending.
• Participates in weekly CAPA Review Board meetings.
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• Mentor other staff as applicable.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist with various projects as assigned by a direct supervisor.
• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Travel up to 10% as required.

SUPERVISION:

• None

EDUCATION:

• Bachelor’s Degree required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS:         

• 5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience.
• Must understand and know how to navigate a CAPA through the Quality System.
• Knowledge and experience in CAPA and medical device product documentation procedures with proven ability or project experience in developing systems and business processes to improve overall efficiency and productivity.
• Working knowledge of ISO 13485, 21 CFR Part 820.100.
• Ability to work cross-functionally with various groups that have opportunity to impact the CAPA outcome.
• Solid analytical and problem solving skills.
• Demonstrates continuous improvement and consistent metrics to achieve business result and quality output.
• Strong project management and organizational skills.
• Excellent attention to detail, resourceful, self-reliant, self-motivated and confident
• Strong project management and organizational skills.
• Excellent verbal and written communication skills. 

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.