CAPA Engineer

CAPA Engineer, Fresenius USA Manufacturing Inc., a Fresenius Medical Care N.A. company, Irving, Texas

Will act as a member of the Corrective Action and Preventive Action (“CAPA”) and the Non-Conformance (“NC”) investigations team, a group of validation engineers tasked with ensuring that Fresenius’ medical devices and equipment designs meet all federal, state, local, and internal quality requirements. Will assure product quality guidance to verify that new product designs meet requirements with respect to safety and efficacy. Will assist in the development of inspection and test methods per product specifications and perform test method validations to ensure accuracy, precision, stability, and reproducibility in manufacturing processes. Specific duties include:

• 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.
• Uses specialized technical/compliance information to guide and influence CAPA, NC and Compliance strategies.
• Ensures compliance with requirements, consistency, and quality of CAPA and NC execution.
• Drives timely execution of CAPA and NC deliverables through monitoring and reporting status to CAPA and NC owners, CAPA Review Board and management.
• 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. Remains conversant with the appropriate regulations, laws and standards to maintain CAPA and NC process compliance and provide up to date guidance and training. Ensures effective CAPA and NC data analysis and investigation, as well as evaluates their trending.
• Builds productive working relationships across business functions.
• Provides 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.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

Requirements:

Position requires a Bachelor’s degree (or an equivalent foreign degree) in Industrial, Chemical or Biomedical Engineering or a closely related field and 2 years of experience as a Quality Engineer in a manufacturing environment. Must also have 2 years of experience (which can have been gained concurrently with the primary experience requirement above) working with the following:

• ISO 13485, 21 CFR Part 820.100 and participating in corporate, internal and external audits (FDA and COFEPRIS);
• Trackwise and Windchill platforms and MINITAB to manage quality assurance projects and harmonize projects at multiple sites;
• Performing and managing product/complain investigations (CAPAs and NCs) in a medical device manufacturing environment;
• Developing and maintaining Master Production Records for medical devices or drugs;
• SAP material management, creation of materials, specification, bill of materials, inspection;
• Supplier quality nonconformance and supplier notifications; and
• Management of contract manufacturing organization (CMO) complaints including developing Quality Agreements for CMOs, Third party Vendors and new parts/services qualifications.