Overview
- The QC Technician is responsible for ensuring that medical devices meet regulatory, quality, and safety standards.
- Inspecting raw materials, in-process components, and finished products, performing tests, and maintaining compliance with industry regulations.
Client Details
My client look beyond technology to the experiences of consumers, patients, providers and caregivers across the health continuum – from healthy living and prevention to diagnosis, treatment and home care. We unlock insights leading to innovative solutions that enable better care at lower cost. With leading research, design and innovation capabilities, we partner with our customers to transform the delivery of healthcare.
We believe that meaningful solutions – those that make a real difference – are developed in partnership with our customers, with an understanding that quality patient care extends outside the hospital walls. By holding ourselves to the highest ethical standards you can focus on what matters most – providing quality care to your patients. From our products to our people, we are committed to leading by example through our environmentally and socially responsible programs.
Description
- Conduct inspections and tests on raw materials, components, and finished medical devices.
- Use measurement tools (e.g., calipers, micrometers, gauges) and analytical equipment to verify compliance with specifications.
- Perform functional and visual inspections of products per standard operating procedures (SOPs).
- Document inspection results and non-conformities in accordance with quality management system (QMS) requirements.
- Support root cause analysis and corrective/preventive actions (CAPA) for quality issues.
- Assist in process validation and equipment calibration activities.
- Ensure compliance with FDA (21 CFR Part 820), ISO 13485, GMP, and other regulatory requirements.
- Participate in internal and external audits.
- Maintain accurate records, logs, and reports to ensure traceability.
- Work closely with cross-functional teams to improve product quality and process efficiency.
Profile
- Education: High school diploma required; Associate’s or Bachelor’s degree in a technical field (e.g., Engineering, Biotechnology, or Quality Management) preferred.
- Experience: 1-3 years of quality control experience in the medical device, pharmaceutical, or biotech industry.
- Knowledge of Standards & Regulations: Familiarity with ISO 13485, FDA 21 CFR Part 820, GMP, and Good Documentation Practices (GDP).
- Technical Skills: Experience with measurement tools, test methods, and inspection techniques.
- Software Skills: Proficiency in Microsoft Office, ERP systems, or QMS software is a plus.
- Attention to Detail: Strong analytical and problem-solving skills.
- Communication Skills: Ability to clearly document findings and collaborate with teams.
Job Offer
- Competitive day rate
