Description

Overview

The Quality Control Inspector, reporting to the Quality Control Supervisor is responsible for all aspects of incoming, in-process, and final inspections, including measurements, recordkeeping, calibration, documentation, production support on an as needed basis and other urgent matters for the Quality Control Department.

Principal Responsibilities

• Perform dimensional and visual first article and in-process/final inspection on raw material, parts, gages, and other equipment, accepting material/product or referring for quality review based on findings.
• Prepare inspection reports; ensure material traceability.
• Initiate Nonconformances (NCR) and Supplier Corrective Action Reports (SCARs); facilitate Material Review Board (MRB) meetings.
• Use a variety of fixed and variable measuring instruments.
• Monitor and coordinate Engineering Change Order (ECO) activity across the organization ensuring compliance with the Quality Management System (QMS); support QMS maintenance for compliance with FDA QSR, ISO 13485, and other regulatory requirements.
• Ensure compliance with electronic document control workflows in QCBD or similar document control tool. Ensure documents are being filed and organized. Support audits in the role as a “Runner”, extracting documents, review them to ensure regulatory compliance and correctness, and present to the Lead Auditor for presentation.
• Coordinate QA/QC tasks with cross functional teams across the organization: support production and product development teams; review Device History Records (DHRs) for completeness and accuracy; execute receiving procedures & support shipping activities.
• Support and promote continuous improvement initiatives to meet business objectives.
• Maintains a safe and healthy work environment by following standards and procedures and complying with legal regulations.
• Perform miscellaneous duties and projects as assigned and required.

Requirements

Training, Skills, Knowledge and/or Experience

• Minimum 1 year of experience performing mechanical inspections in a manufacturing environment; optical inspection experience preferred.
• Experience working in medical devices and FDA QSR and ISO 13485 preferred.
• Understanding quality control processes, methods, and standards.
• Proficiency with Microsoft 365 apps suite.

Competencies

• Strong data collection & analysis, problem solving, presentation and communication skills.
• Strong attention to detail.
• Ability to collaborate effectively with cross-functional teams.

Education Requirements

High School Diploma or GED required.

Supervisory Responsibility

None

Working Conditions

This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms.

Physical surroundings

This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.

Physical Effort

While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear.

Work Schedule / Travel

In-person, Mon to Fri in Gardner, MA; occasional travel, with periodic presence in the Windham, ME site.

Other Requirements

This position involves access to technology that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant’s capacity to serve in compliance with U.S. export controls.