Senior Manager Quality Engineer; Medical Devices and Pharma

Senior Manager Quality Engineer (Medical Devices and Pharma Experience required)

Validation & Engineering Group (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas:
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

• Accountable to provide Quality oversight of FP Technologies method stewardship, modeling, and material characterization.
• Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to FP Core Technologies and/or to sites.
• Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market.
• Ensures alignment strategies for methods transfer across multiple sites.
• Works with External Supply Quality and/or other quality counterparts to ensure there is a robust plan in place when receiving methods from a CMO or supplier.
• Provides Quality oversight to final product core technologies activities and deliverables.
• Qualifies and approves protocols and technical reports for method development.

• Masters or Bachelors Degree in Science or Engineering.
• Hard skills: 5+ years of experience in Validation Qualifications, process/Medical Devices experience, GMP (quality management systems, manufacturing), Audits / Inspections experience.

additional workload on the team

Positions available for Puerto Rico.

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.