Quality Technician

Location: Southborough, MA

About the role

Apply 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 (scanheads, tables, and modules) for shipment.

Responsibilities

• Coordinate and maintain calibration of tools and equipment for all in-house and field technicians with external calibration supplier.
• Maintain Device History Records for product release, covering both internal and external manufacturing activities.
• Maintain MRB material flow and keep records systematically.
• Perform inspections of parts and keep records as needed by Quality/Engineering function.
• File and maintain Service Records and Customer Files.
• Prepare daily and monthly compliance reports for quality, operations, and customer support.
• Participate in the completion of internal audits.
• Assist in document control activities.
• Assist in preparation for third-party audits.
• Perform inspections of 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.
• Ability to work within tight deadlines and manage time effectively.
• Strong team player with a flexible attitude to work priorities.
• Excellent computer skills (MS Office applications).
• High school graduation minimum; bachelor’s in any technical field or technical certification preferred.

Skills

• Prior Quality Assurance experience preferred.
• Lean Six Sigma White/Yellow Belt a plus.
• Medical device experience.
• Close attention to detail.
• Excellent organizational skills.
• ISO 13485 Internal Auditing training.

Pay

The hourly pay range for this position is $29.81–$32.21 per hour, based on experience.

Benefits

• Eligibility for company bonus program.