Senior Manager Quality Engineer (Medical Devices and Pharma Experience required)
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
Quality approval of protocols and technical reports for method development
Masters/Bachelors Degree in Science or Engineering
Why is the Position Open?
additional workload on the team
Top 3 Must Have Skill Sets:
hard skills (5+ years of experience)
Validation Qualifications experience
Combination process / Medical Devices experience
GMP experience (quality management systems, manufacturing)
Audits / Inspections experience
Qualifications
Top 3 Must Have Skill Sets:
hard skills (5+ years of experience)
Validation Qualifications experience
Combination process / Medical Devices experience
GMP experience (quality management systems, manufacturing)
Audits / Inspections experience
Additional Information
Positions available for Puerto Rico.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.