Position Summary

The QC Engineer performs a mix of technical, analytical, and compliance‑focused responsibilities to ensure product safety, efficacy, and conformance. This includes conducting precise dimensional inspections, programming QC measurement systems, generating inspection reports, and maintaining documentation in alignment with cGMP and global quality standards.

This role partners cross‑functionally with engineers, technicians, suppliers, and quality leaders to support investigations, continuous improvement, and new equipment qualification.

Key Responsibilities

Quality Control Testing & Documentation

• Perform QC testing for raw materials, in‑process materials, and finished products, ensuring results meet defined specifications and are documented accurately.
• Support development and implementation of QC procedures, protocols, and documentation aligned to cGMP and regulatory standards.
• Participate in investigations for Out‑of‑Specification (OOS) and NCMR events.

Dimensional Inspection & Measurement Systems

• Develop and optimize measurement programs using CAD models, engineering drawings, and dimensional specifications for QC inspection systems.
• Perform precise dimensional inspections using:
• OGP multisensor laser systems
• Keyence systems
• Hexagon & Nikon CMM
• Optical comparators, microscopes, measure scopes, meters, and other precision equipment
• Program CMM equipment using PC‑DMIS CAD++ for new and routine parts.
• Lead and execute complex First Article Inspections, including graphical data representation.

Technical Reporting, Analysis & Investigation

• Generate clear and concise inspection reports and assess measurement results for trends, issues, or required corrective actions.
• Troubleshoot and resolve programming and instrumentation issues; collaborate with vendors/suppliers as needed.

Quality Systems & Compliance

• Support qualification activities including IQ/OQ/PQ for new QC equipment and decommissioning where appropriate.
• Participate in change controls and GMP/GxP assessments for QC measurement systems.
• Contribute to SOP development, calibration activities, and continuous improvement initiatives.

Cross‑Functional Collaboration & SME Support

• Serve as a technical SME for QC measurement systems (OGP, Keyence, etc.).
• Support training for technicians and engineers on dimensional inspection methods, programming, and documentation.

Qualifications

• Bachelor’s degree in Scientific field with no experience
• In lieu of a degree, 4+ years of work experience in a technical work setting, having focused competence in the use of Quality Dimensional Tools will be accepted
• Expertise in precision mechanical measurement instruments and CMM operation.
• Ability to interpret complex blueprints and advanced knowledge of Geometric Dimensioning & Tolerancing (GD&T).
• Working knowledge of domestic and international regulations and standards (ISO, QSR, UL, CSA, VDE).

Skills & Competencies

• Strong analytical problem‑solving skills and the ability to make data‑driven decisions.
• Effective written communication, including technical reporting.
• High proficiency in MS Office (Outlook, Teams, Word, Excel).
• Strong ethical conduct and adherence to quality standards.

Working Conditions

• Prolonged periods of sitting or standing.
• Ability to climb stairs, ladders, and ramps.
• PPE must be worn correctly most of the day.
• Ability to operate heavy machinery.
• Must be able to lift/move up to 50 lbs.
• Travel: Domestic 0.05%; International 0.05%.

 #biojobs