QA/QC Engineer I

Job Description

Job Description

Overview

The Quality Assurance Engineer I supports quality assurance and product development activities in accordance with medical device regulations, including 21 CFR 820, the Medical Device Directive (MDD), ISO 13485, and ISO 14971. Under the guidance of senior QA staff, the engineer assists with incoming inspection and product release tasks by following established procedures to help ensure products meet defined specifications and quality requirements. The duties will also include providing support for document control activities, helping maintain quality records, assisting with CAPA documentation, and participating in basic product review investigations as assigned. The QA Engineer I also works with Product Development by completing required design control documentation and following established processes for new and existing product lines.

 

Responsibilities

• Support QA/QC activities by following established procedures and requirements related to 21 CFR 820, ISO standards, and CE mark guidelines under the direction of senior team members.
• Perform basic incoming inspections and final product checks using predefined inspection criteria and document results accurately.
• Assist with complaint intake activities by logging complaints, organizing required documentation, and escalating issues to senior QA staff for evaluation in accordance with regulatory procedures.
• Provide support for document control tasks, including updating logs, routing documents for approval, and maintaining organized and compliant document files.
• Help maintain quality records, such as device history records, QA logs, test reports, and equipment records, ensuring files are complete and properly stored.
• Assist in tracking product traceability data by entering information into tracking systems and verifying completeness.
• Participate in validation activities (IQ, OQ, PQ) by collecting data, preparing documentation, and performing routine test steps under supervision.
• Support calibration and equipment maintenance programs by scheduling calibration service, maintaining calibration logs, and helping track equipment status.

Qualifications

Minimum:

• Bachelor’s degree in electrical or mechanical engineering 

Preferred:

• Some experience in the medical device industry, quality assurance, regulatory affairs, or a related engineering environment; exposure to products with electronic components is preferred.
• Familiarity with basic quality and regulatory concepts such as 21 CFR 820, 21 CFR Part 11, and ISO 13485; coursework, project work, or prior internship experience in these areas is preferred.
• Experience supporting CAPA‑related activities (e.g., gathering data, documenting actions, assisting with investigations) within a structured quality system is beneficial.