Overview
Senior Quality Engineer Jobs in Massachusetts, United States at Shoolin Inc
Title: Senior Quality Engineer
Company: Shoolin Inc
Location: Massachusetts, United States
Job Title: Senior Quality Engineer
Location: Massachusetts (Onsite)
Employment Type: Contract
Overview:
Seeking a Quality Engineer with 4–6 years of experience in the life sciences industry to support quality systems, compliance, investigations, and continuous improvement in a GMP-regulated manufacturing environment.
Required Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field
- 4–6 years of Quality Engineering experience within the life sciences, pharmaceutical, biotech, or medical device industry
- Strong knowledge of GMP, quality systems, and regulatory compliance
- Experience with CAPA, deviations, nonconformance investigations, and root cause analysis
- Experience supporting audits and quality documentation
Key Responsibilities:
- Support quality assurance and compliance activities.
- Lead investigations, CAPA, and nonconformance resolution.
- Review and maintain quality documentation.
- Partner with Manufacturing and Validation teams to ensure product quality.
- Support internal and external audits and regulatory inspections.
Preferred Qualifications:
- Experience with FDA, ISO 13485, or cGMP regulations.
- Knowledge of statistical quality tools and risk management.
