CAPA Engineer

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PURPOSE AND SCOPE:

The CAPA Quality Engineers are assigned Corrective Action and Preventive Action (CAPA) investigations as well as Non-Conformance (NC) investigations and process activities. Ensure compliance to process requirements and the consistency/quality of CAPAs and NCs.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality Systems personnel and responsible to drive continuous improvement on Root Cause investigations and CAPA as a core Quality Business process/function(s).
• Responsible for assigned CAPAs and will provide guidance to CAPA team(s).
• Supports the rollout of any new CAPA solutions (tools, techniques, and/or process enhancements).
• Provides project direction, coaching, and mentoring for CAPA teams as required.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving CAPA and NC issues.
• Use technical/compliance information to guide and influence CAPA, NC and Compliance strategies.
• Ensure compliance to requirements and the consistency and quality of CAPA and NC execution.
• Drive timely execution of CAPA and NC deliverables through monitoring and reporting status to CAPA and NC owners, CAPA Review Board and management.
• Interface 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.
• Develop and deliver 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.
• Builds productive working relationships.
• May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
• May refer to senior level staff for assistance with higher level problems that may arise.
• Escalates issues to supervisor/manager for resolution, as deemed necessary.
• 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 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.

EDUCATION:

Bachelor's Degree required

EXPERIENCE AND REQUIRED SKILLS:        

• 2 - 5 years' related experience; or an advanced degree without experience; or equivalent directly related work experience.
• Working knowledge of ISO 13485, 21 CFR Part 820.100.
• Must understand and know how to navigate a CAPA through the Quality System.
• 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.