Quality Control Engineer

Dosentrx is transforming how oral drug therapies are delivered and monitored. Our cleared, software‑integrated medical device is already improving patient outcomes, with adoption growing rapidly year over year. As we scale, we’re looking for a quality leader who thrives in a fast‑paced, hands‑on environment and is motivated by building systems that ensure safety, reliability, and regulatory excellence.

Role Summary

We are seeking a proactive, detail-oriented Quality Control Engineer to execute quality control and inspection activities supporting the Quality Management System (QMS) for our commercialized medical device.

This role focuses on receiving inspection, in-process and final inspection, calibration and maintenance of test equipment, nonconformance documentation, and support of CAPA investigations and internal audits, ensuring compliance with ISO 13485 and FDA QMSR (21 CFR 820).

The ideal candidate is hands-on, highly organized, and comfortable working closely with Production and other departments to identify, document, and resolve quality issues.

Responsibilities

• Perform receiving inspection of incoming materials and components per specification, using the applicable Receiving Inspection Forms.
• Perform in-process and final inspection of product per Device Master Record (DMR) specifications and acceptance test plans.
• Identify and document nonconforming product or process conditions, and support disposition (rework, use-as-is, scrap, return to supplier).
• Support CAPA investigations by providing inspection data, root cause analysis input, and verification of implemented corrective actions.
• Maintain calibration and maintenance records for inspection, measuring, and test equipment.
• Support internal audits by providing requested records and participating in audit activities as assigned.
• Support supplier quality activities, including receiving inspection criteria development and supplier corrective action follow-up.
• Maintain accurate and complete Device History Record (DHR) entries for inspection and test activities.
• Apply statistical techniques (e.g., sampling plans, acceptance criteria) to inspection and testing activities as required.
• Support product and process validation activities, including test protocol execution and documentation.
• Collaborate with Production to identify recurring quality issues and support root cause investigation at the process level.
• Escalate significant quality issues or inspection trends in a timely manner.

Requirements

• Bachelor's degree in engineering, quality, or a related technical discipline (or equivalent experience).
• 1-3 years of experience in quality control, inspection, or manufacturing quality within a regulated industry; medical device experience preferred.
• Working knowledge of inspection techniques, sampling plans, and test protocols.
• Familiarity with ISO 13485 and FDA QMSR (21 CFR 820) as applied to production and inspection activities.
• Experience with calibration and maintenance of inspection, measuring, and test equipment a plus.• Experience using hand-held inspection tools (e.g., calipers, micrometers) to perform dimensional inspection.
• Strong attention to detail and accuracy in inspection and documentation.
• Comfortable working hands-on with production and inspection equipment.
• Clear written communication of inspection results, nonconformance reports, and test data.
• High integrity, strong interpersonal skills, and a proactive, solution-oriented approach.

This position is open to candidates of all genders. Please send your CV and cover letter to: [email protected]