Senior Quality Systems Engineer-CAPA

Job Description

The Senior Quality Engineer, CAPA is responsible for CAPA system ownership, execution, and support for Veran Quality Assurance as required, in close collaboration with groups within Veran and OSTA.

This position may lead a team of SMEs in the execution of CAPA activities to ensure that actions are executed in compliance with all applicable global regulations and laws. This position may also be responsible for the creation and/or revision of local/ global processes to support the VMT organization to meet all applicable regulations and laws, driving corrective and preventive actions. This position requires a thorough understanding of FDA regulatory requirement for complaint handling and MDR reporting. Provides supports in the continuous improvement effort of the VMT quality system for processing CAPAs to meet FDA, ISO and all applicable international regulatory requirements, and corporate guidelines. Proposes solutions concerning quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. Performs timely closure of CAPA issues in accordance with established procedures. Lead CAPA, Nonconformance and other QMS projects to improve department processes, procedures, and responsibilities.

Job Duties

* Lead corrective and preventative action (CAPA) activity. Apply systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving systemic non-conformance.

* Guide and support colleagues in the CAPA investigation process, assisting to remove roadblocks to timely investigation completion.

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* Communicate directly with internal VMT colleagues and Olympus field personal as necessary to support CAPA investigation and resolve issues. Use investigation findings to generate written communications. Ensure consistent messaging to all concerned on similar concerns, coordinating with internal stakeholders to review content of communication.

* Review CAPA records for accuracy and completeness. Perform CAPA issue closure in a timely manner. Identify, and assist in removing, roadblocks to timely file closure.

* Provide technical support to Operations technicians, administration staff and production shop floor staff relative to technical investigations. Serve as a technical trainer to the VMT Quality team members as needed.

* Develop solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

* Work directly with manufacturing sites, subcontractors, and OEMs to facilitate corrective and/or preventive actions related to quality problems identified through CAPA investigation and/or other sources of quality data. Review and approve manufacturer’s investigations for accuracy and relevance to reported complaints.

* Develop, manage, and run reports in database systems for the purpose of trend monitoring and/or CAPA investigation. Lead and facilitate responsible parties to resolve issues. Reviews associated QMS records to ensure the applicable assessment, investigation and analysis records are appropriate and complete.

* Assist local management team in reviewing process implementation and provide recommendation to resolve processing challenges, increase productivity and improve workflow.

* Support local process implementation and global continuous improvement initiatives by serving as a subject matter expert in the field of complaint processing on topics relating to physical device inspection, complaint investigation and data trending.

* Perform other related duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

* A four-year degree in a technical discipline (e.g., EE, ME, BME, Quality Assurance), or equivalent knowledge & experience.

* Minimum of 5 years’ experience dealing with regulatory or quality assurance issues in the medical industries. Specific experience in CAPA activities. Knowledge of Quality System Requirements (21 CFR 820 & 803), ISO 13485 and the MDD is required. EUMDR experience desirable.

*  Other Considerations (travel/hours availability, etc.):Available to travel to customer sites for product evaluation, ~10%.  Available to travel to the manufacturing sites for product training, ~5%. This is primarily an on-site position; a limited hybrid work schedule is possible.

PREFERRED QUALIFICATIONS:

* Previous experience working with different CAPA handling systems, e.g. Agile, Etc.

* Effective written and verbal communication skills.

* Strong analytical, organizational, communication and interpersonal skills are required.

* Computer literate with experience in Microsoft Office Suite.

* Previous experience working with complaints, CAPAs, NCRs, and other quality management system functions.