Senior Quality Engineering Leader - Medical Devices

Validation & Engineering Group; Rhode Island; 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)

• Full-time

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
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

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

Positions available for Puerto Rico.

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

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