Job Description Summary

Responsible to primarily manage the CAPA systems to act as the lead to CAPA Owner/Team providing project direction throughout CAPA stages. This role also supports other quality systems such as NCR, complaints and other systems as deemed required.

Job Description

Job Functions

- Identify root cause, corrective action(s), preventive action(s), monitoring plan(s) and the overall effectiveness for resolution of CAPA and NCR issues while applying problem-solving methodologies.

- Lead CAPA process; including, collecting and analyzing data to identify root cause and ensuring verification of effectiveness plans are comprehensive as identified by monitoring metrics.

- Drive execution of CAPA deliverables through monitoring and reporting status to CAPA Review Board and management in a timely manner. Ensure compliance to requirements and consistency/quality of CAPA execution.

- Drive continuous improvement in Management Review reporting, handling of complaint metrics and reporting of CAPA and NCR metrics 15%

Participate in the rollout/implementation of any new CAPA and NCR solutions (tools, techniques, and/or process enhancements). This will also include providing training on a periodical basis for the relevant CAPA topics.

- Partner with management and peers to assess and improve the adequacy of the processes which includes but is not limited to the remediation of CAPA and NCR deficiencies noted in audits and/or inspections.

- Drive continuous improvement for effective CAPAs and NCRs as core Quality Business process/function(s).

- Other incidental duties

Education/Experience

- Bachelor's degree in engineering or Scientific field

- 4 years of experience including either industry or industry/education or

Master's degree or equivalent in Engineering or Scientific field

Required Skills

Strong computer skills in the use of MS Office Suite

• Strong documentation, communication and interpersonal relationship skills.

• Strong negotiating and relationship management skills.

• Certified as ISO 9001/ISO 13485 internal auditor or any related certification.

• Substantial knowledge and understanding of statistical techniques.

• Excellent written and verbal communication skills in both English and Spanish.

• Strong interpersonal skills: conflict resolution, ability to work in a team environment and communicate effectively at all organizational levels.

• Knowledge of Quality Analytics Tools.

• Ability to recognize problems and develops and executes strategies with team input.

• Good problem-solving, organizational, analytical and critical thinking skills

• Moderate knowledge of validation and improvement of automated equipment and procedures.

• Strict attention to detail

• Ability to recognize problems and develops and executes strategies with team input.

• Ability to understand engineering drawings, Bills of Materials, and operational procedures

• Ability to manage competing priorities in a fast-paced environment.

• Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.

• Comply with the standards, regulations, procedures and quality manuals applicable to the company.

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules).

Required Skills

Optional Skills

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Primary Work Location

DOM Santo Cristobal - Nave 15-Bachata

Additional Locations

Work Shift

DO Admin SH 45H 8AM-5PM (Dominican Republic)