Quality Engineer II
Location
Chelmsford, MA
Level
Mid-Level
Department
MedTech
Type
Salary
$82,000 - $124,000
Job Description
Posted on:
2025-11-28
Responsibilities
- Review and approve quality records and production documentation for compliance.
- Lead validation activities and test method validation.
- Analyze process data using statistical tools for decision-making.
- Conduct risk assessments and develop PFMEA.
- Manage nonconformance investigations and CAPA development.
- Author or revise inspection plans and manufacturing procedures.
- Support internal audits and regulatory inspections.
Job Requirements
- Bachelor’s degree in engineering, science, or related field.
- 1–3 years of experience in quality or manufacturing engineering in a regulated environment.
- Knowledge of ISO 13485, 21 CFR 820, and internal QMS standards.
- Proficiency in quality tools (FMEA, Gage R&R).
- Basic understanding of manufacturing controls and process validation.
- Familiarity with continuous improvement principles (Lean, Six Sigma).
- Strong organizational skills and attention to detail.
