What are the responsibilities and job description for the Quality Engineer position at TRIAD Engineering Corp?
Our busy, well-established client is seeking a Quality Engineer to support the Quality Manager in maintaining and improving the QMS for medical device manufacturing. This is a hands-on role where the Quality Engineer will be involved in CAPA/Complaint handling, validation, sterile processing, and supplier/contractor management in a GMP environment. They will also perform root cause analysis and implement corrective actions while developing inspection criteria, acceptance tests, and equipment specifications. The Quality Engineer will also develop, administer, and maintain quality assurance procedures and activities to ensure that all quality inspections and products comply with applicable quality standards and requirements, and will investigate product quality issues with engineering and production to drive containment and resolution. They will be responsible for developing and maintaining sterilization and clean room validation, and also for providing support as needed during FDA inspections, international regulatory surveillance audits, and vendor audits. To be considered for this role, candidates should hold a Bachelor's degree in Engineering or similar and have at least 2 years of experience working in a medical device environment. If you are seeking a new opportunity in the new year, this could be the role for you! Please apply if you meet the above qualifications and live in the Worcester, MA area.
Additional Responsibilities and Qualifications
- Perform equipment calibration, validation, and maintenance records to ensure they are performed correctly and on time.
- Monitor cleanroom and perform routine product bioburden to specified levels
- Provide support as needed during Internal Audits.
- Assist Customer Service with the preparation of outgoing shipments, particularly the assembly, wrapping, and finalization of pallets.
- Assist as needed with the receipt, verification, and clearance of incoming product shipments.
- Perform or assist with special projects as directed by Quality Manager.
- Knowledge of FDA QSR 21 CFR Part 820, ISO 13485:2016, ISO 14971
- Experience with CAPA, validation (IQ/OQ/PQ), sterilization/bioburden.
- Experience with audits (FDA, EU Notified Bodies, internal)
- Familiarity with design/process controls, change control, statistics, and risk-based decisions.
- Cleanroom Validations (including calibration and bioburden)
- Proficiency with quality tools (FMEA, 5 Whys, Ishikawa, SPC) and document control systems.
- This engineer will have some EHS oversite including managing the activities of facility-related suppliers and contractors and facility temperature monitoring
Salary : $100,000 - $125,000