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Manufacturing Engineer
2 months ago
Responsibilities:
Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on Test Method Validation and EUMDR Validation Remediation of medical devices. Provide statistical analysis of the date to support the reports. 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 effec
tive 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.
Qualifications:
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements. 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. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Teamwork oriented and self-starter.
