Quality Technician
Optos · Southborough, MA · 2 days ago
On-siteQuality Assurance$29.81–$32.21/hrFull-time
About the role
The Quality Technician role involves applying quality assurance and medical device regulatory principles and techniques to maintain records, ensure the effective operation of the Quality Management System (QMS) through internal auditing, and approve equipment for shipment.
Responsibilities
- Cook up and maintain calibration of tools and equipment for all in-house and field technicians with external calibration suppliers.
- Maintain Device History Records for the purpose of product release. For internal and external manufacturing activities.
- Perform inspections of parts and keep records as needed by Quality/Engineering function.
- Filing and maintenance of Service Records and Customer Files.
- Prepare daily and monthly compliance reports for quality, operations and customer support.
- Participate in the completion of internal audits.
- Aid in document control activities.
- Aid in preparation for third party audits.
- Inspect modules at supplier sites.
- Provide support to the Manager QA/RA-North America for any tasks relating to the quality system and regulatory requirements.
Requirements
- Experience with Calibration of Tools and Equipment.
- Experience performing first and second party audits.
- Ability to produce high quality work under pressure and within tight timescales.
- Strong team player with flexible attitude to work priorities.
- Excellent computer skills (MS Office applications).
- Highschool graduation minimum, bachelors in any technical field or technical certification preferred.
Qualifications
- Prior Quality Assurance Experience preferred.
- Leverage of Lean Six Sigma White/ Yellow Belt a plus.
- Medical Device experience.
- Close attention to detail.
- Excellent organizational skills.
- ISO 13485 Internal Auditing training.
Skills
- Prior Quality Assurance Experience preferred.
- Leverage of Lean Six Sigma White/ Yellow Belt a plus.
- Medical Device experience.
- Close attention to detail.
- Excellent organizational skills.
- ISO 13485 Internal Auditing training.
Benefits
At Optos, we offer a highly competitive compensation and benefits package. Eligibility for company bonus program. The hourly pay range for this position is $29.81–$32.21 per hour, based on experience.
Pay
The hourly pay range for this position is $29.81–$32.21 per hour, based on experience.
Schedule
N/A