- Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices.
- Provide statistical analysis of the date to support the reports.
- Generation and implementation of change controls and engineering notices (ECO).
- Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Troubleshooting equipment/processes that do not perform as intended during validation runs.
- Recommend process/quality improvements as part of validation runs. Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
- Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
- Work on project teams with other internal departments, external vendors, and customers as required.
- Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
- Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
- Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
- Performs other related duties as necessary.
- BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
- Lean/Six Sigma Green or Black Belt Certification is a plus.Manufacturing equipment, manufacturing processes, stability or aging, required.
- Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.
- Knowledge in Organizational Excellence and Lean/Six Sigma.
- Strong Project Management skills.
- Ability to lead teams through complex projects and provide departmental technical leadership.
- Must have excellent communication skills and a strong track record of working cross-functionally.
- Must have demonstrated ability to think strategically.
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Description
Responsibilities:Requirements:
