Senior Quality Engineer
at Engtal
in
Boston,
Massachusetts
Posted in Other about 3 hours ago.
Type: full-time
Job Description:
Key Responsibilities:
- Lead the development and implementation of robust quality systems for biotech products.
- Ensure full compliance with FDA, ISO 9001, ISO 13485, and GMP regulations.
- Investigate non-conformances and manage CAPA processes, performing root cause analysis and corrective/preventive actions.
- Collaborate closely with R&D, manufacturing, and regulatory teams to integrate quality standards in new product development and ongoing processes.
- Conduct internal and external audits, risk assessments, and lead process validations (IQ, OQ, PQ).
- Drive continuous improvement initiatives across the organization by applying Lean Six Sigma methodologies.
- Provide guidance, leadership, and mentorship to junior quality engineers and cross-functional teams to elevate overall quality standards.
Qualifications:
- Bachelor's in Engineering, Quality, Life Sciences, or a related field (Master's preferred).
- 5+ years of experience in quality engineering, ideally in biotech or pharmaceutical industries.
- Comprehensive understanding of FDA regulations, ISO standards, GMP, and quality management systems (QMS).
- Proven track record in CAPA management, root cause analysis, and risk management.
- Hands-on experience with process validation (IQ, OQ, PQ) and continuous improvement tools (Lean, Six Sigma).
- Strong communication and leadership skills, with the ability to collaborate across teams and drive results.