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

Validation & Engineering Group; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

A leading services supplier in the medical devices sector seeks a Senior Manager Quality Engineer with expertise in validation qualifications and process. The role involves providing quality oversight, leading a technical team, and ensuring compliance with industry standards. Candidates should hold a Master's or Bachelor's degree in Science or Engineering and possess at least 5 years of relevant experience. This is a significant opportunity to contribute to high-quality outputs in a dynamic industry.

Qualifications

• 5+ years of experience in Validation Qualifications.
• Experience in process and Medical Devices.
• Knowledge of GMP, Audits, and Inspections.

Responsibilities

• Provide Quality oversight of method stewardship and material characterization.
• Lead a team for Quality technical expertise and compliance assessments.
• Ensure alignment strategies for methods transfer across sites.
• Work with External Supply Quality for robust plans with CMOs.
• Qualify and approve protocols and technical reports.

Skills

Validation Qualifications

GMP (quality management systems)

Audits / Inspections

Medical Devices experience

Process experience

Education

Masters or Bachelors Degree in Science or Engineering

Job description

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.

Responsibilities

• 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.

Qualifications

• 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.

Why is the Position Open?

additional workload on the team

Location

Positions available for Puerto Rico.

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