Recruiter :
Darren Nelson
- Conducts root cause and CAPA investigations
- Ensures ISO 9001 & FDA compliance
- Improves processes and supports production quality
Location: Devens, MA
Schedule: 1st Shift | 8:30 AM – 4:30 PM | Some flexibility
Contract Duration: 12 months (possibility to extend)
Pay Rate: $40/hour
About the Role
We are seeking a Quality Engineer I to join a dynamic manufacturing team in a cleanroom assembly environment. This role is ideal for a detail-oriented, proactive professional who thrives in cross-functional settings and enjoys solving complex problems. You will be instrumental in driving quality initiatives, ensuring regulatory compliance, supporting root cause investigations, and maintaining high standards of production quality.
This is a hands-on manufacturing-focused role, supporting internal processes and production quality, with limited external client interaction.
Key Responsibilities
- Apply Quality Engineering principles, tools, and techniques to optimize processes and systems in alignment with regulatory requirements.
- Lead root cause investigations and implement corrective and preventive actions (CAPA) for production issues.
- Support and conduct internal and supplier audits to ensure compliance with ISO 9001 and FDA Quality System Regulations.
- Maintain and coordinate validation, calibration, and environmental monitoring programs.
- Collect, review, and interpret quality data to generate trend reports and metrics.
- Develop, update, and maintain SOPs, quality procedures, and the Quality Management System (QMS).
- Review and approve quality documentation, including reports and supplier indexes.
- Collaborate effectively with cross-functional teams to resolve manufacturing issues.
Qualifications
- Education: Bachelor’s degree in Engineering, Life Sciences, or related field.
- Experience: Minimum 3–5 years as a Quality Engineer in a manufacturing or cleanroom environment.
- Proven expertise in root cause analysis, deviation/complaint investigations, and corrective action implementation.
- Knowledge of ISO 9001 and regulatory compliance requirements.
- Experience with ERP systems (e.g., Epicor, ETQ) preferred.
- Certification in Quality Engineering (CQE) or Lean Six Sigma is a plus.
- Strong written and verbal communication skills; ability to collaborate with all levels of staff.
Skills & Attributes
- Excellent time management and organizational skills.
- Ability to work independently and prioritize tasks in a fast-paced environment.
- Detail-oriented with a strong analytical mindset.
- Proficiency in MS Office (Word, Excel, Access).
Work Environment
- Primarily office-based with occasional cleanroom exposure.
- Standard lighting, temperature, and ventilation.
- Some physical activity required (walking, bending, lifting objects under 10 lbs).
Interview Process:
- Initial interview with the hiring manager
- Onsite panel interview