Quality Engineer - Katalyst Healthcares & Life Sciences
Westbrook, ME 04092
About the Job
Responsibilities:
- Conduct and lead PFMEA activities to identify and mitigate potential process risks.
- Collaborate with cross-functional teams to develop and implement process improvements based on PFMEA findings.
- Perform and facilitate FMEA sessions to assess product and process risks.
- Develop and implement corrective actions to address identified risks and enhance product reliability.
- Lead CAPA investigations to determine root causes of non-conformities and implement effective corrective actions.
- Monitor and evaluate the effectiveness of implemented CAPAs to ensure sustained improvements.
- Manage and investigate NCRs to identify root causes and implement appropriate corrective actions.
- Maintain accurate and detailed documentation of NCRs and related activities.
- Ensure compliance with FDA regulations and guidelines related to manufacturing and quality processes.
- Participate in internal and external audits to demonstrate adherence to FDA requirements.
- Develop, implement, and maintain quality assurance processes and procedures.
- Conduct regular quality audits to ensure compliance with internal and external standards.
- Collaborate with manufacturing teams to resolve quality issues and implement process improvements.
- Bachelor's degree in engineering, Quality Management, or a related field.
- Proven experience in quality engineering within a manufacturing environment.
- Strong knowledge and hands-on experience with PFMEA, FMEA, CAPA, Client, and FDA regulations.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills.
- Ability to work effectively in cross-functional teams.
- Certification in Quality Management (e.g., CQE, Six Sigma) is a plus.
Source : Katalyst Healthcares & Life Sciences