Sr. Quality Engineer/C&Q
- Caguas, PR
- Permanente
- Tiempo completo
- Review plant defect reports, customer complaints, failure investigations and audit findings to assess manufacturing related issues that may impact quality and recommend courses of corrective action.
- Conduct manufacturing non conformances investigations, customer complaints, CAPA, failure investigations and audit findings.
- Escalate manufacturing related issues that may impact quality and recommend courses of corrective action.
- Participate in regulatory agencies audits.
- Assist in the investigation of product non conformances and the gathering of information during regulatory inspections and field actions when required
- Approve or review product investigations reports.
- Perform and report line defects trend analysis, cost of quality, and period quality summaries.
- Participate in new product or technology transfers to assess the impact they may have on the quality and reliability of the product – assist in process validation protocol.
- Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends.
- Perform quality system audits to determine compliance to FDA, ISO, and internal quality systems regulations and perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or contractor.
- Participate in the development, delivery, and administration of quality training programs including but not limited to GMP.
- Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement.
- Provide leadership and guidance to a team of hourly or salary associates, including assigning tasks, setting clear goals, and monitoring performance, as required.
- Facilitate training sessions to ensure team members are equipped with necessary skills and knowledge.
- Develop individual team members through coaching and mentoring.