Website Agile Workplace Staffing
Agile is looking for a Quality Technician in Lowell MA
The Quality Technician is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, and quality systems.
What you will be doing
- Complies with company, quality and safety standards, policies, and procedures
- Under Quality Engineer (QE) oversight, assist with qualification and validation (IQ, OQ, PQ).
- Compile and analyze statistical data to assess process capabilities and control processes
- Develop inspection test methods and draft inspection procedures with QE oversight
- Handle Calibration Management including new and current equipment that requires calibration, calibration supplier management and out of tolerance reporting as required
- Handle Environmental Monitoring Management including collecting samples, testing, entering and trending results and out of tolerance reporting as required
- Support the nonconforming material reporting process including verifying nonconformance descriptions, evaluating to determine root cause of the nonconformance and proposing final disposition of nonconforming product
- Review and approve inspection and device history records as required
- Support CAPA process by assisting in the investigation and implementation of corrective action
- Identify areas of improvement and participate in continuous improvement projects
- Perform Gemba walks and participate in 5S activities
- Support QEs and other duties as assigned
What we require from you:
- High School diploma.
- 1-3 years of experience in manufacturing environment (preferred requirement – Medical Device industry)
- Knowledge of medical device regulations (21CFR820, ISO 13485)
- Technical training and/or experience in related field
- Working knowledge of basic inspection processes and measurement practices
- Must be able to read, write and speak fluid English
- Ability to read and interpret assembly drawings and specifications
- High proficiency in use of computer systems using standard business software: Outlook, Word, PowerPoint, Excel, MRP/ERP systems
- Strong verbal and written communication skills
- Ability to work with a wide variety of functional areas including but not limited to Program Management, R&D, Manufacturing and QA as required accomplishing results with minimal guidance
- Excellent organization and time management skills with an ability to think proactively and prioritize work
- Flexible and able to accommodate changing priorities and directions
Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.
We are Committed to Your Success
We offer a competitive package, dynamic work environment, collaborative team, and space to learn, grow and thrive. Qualified applicants will receive consideration regarding race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, veteran status, or disabilities.
If you are a hardworking, driven professional looking for your next team. We are committed to employing a diverse workforce, let’s start a conversation. Apply today!
To apply, please visit the following URL:https://cats.agilewps.com/careers/index.php?m=careers&p=applyToJob&ID=1776→