We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee Manufacturing Quality projects and line transfers for a Medical Device company. The perfect candidate will perform the following activities:

Key Responsibilities:

• • Support quality assurance activities associated with transferring and starting up manufacturing operations at the new site.
  • Review, execute, and approve validation documentation, including protocols, test scripts, test data, and final reports.
  • Provide QA oversight for process validation activities to ensure processes are qualified, controlled, and appropriately documented.
  • Support equipment qualification efforts, including IQ, OQ, and PQ activities for manufacturing equipment and related systems.
  • Partner with Manufacturing, Engineering, Validation, and Quality teams to ensure validation deliverables are completed on time and in compliance with applicable procedures and regulations.
  • Assess validation packages for completeness, accuracy, traceability, and adherence to GMP and medical device quality system requirements.
  • Support investigation and resolution of validation-related deviations, discrepancies, and change controls.
  • Generate, review, and approve validation summary reports and supporting documentation for management and quality records.
  • Support QA activities associated with the QMS integration of 2 companies.
  • Modify SOPs to complete QMS integration.
  • Complete Change Control activities.
  • Complete the bulk download of documents and records from a Quality Management System.

Required Qualifications:

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent relevant experience.
• Experience in the medical device industry within Quality Assurance, Validation, Manufacturing Quality, or a closely related function.
• Strong working knowledge of process validation, equipment qualification, and GMP requirements in a regulated manufacturing environment.
• Demonstrated experience reviewing and approving validation documentation and technical reports.
• Familiarity with manufacturing operations and the practical application of quality requirements on the production floor.
• Ability to work independently while coordinating effectively with cross-functional stakeholders.
• Strong technical writing, documentation review, and problem-solving skills.
• Excellent attention to detail and ability to manage multiple priorities within a time-bound project.

We are a specialized Global staffing firm that works for Fortune 500 companies in the Medical Device, Pharmaceutical, and Biotec industries, finding qualified personnel.