Quality Control Analyst – Medical Devices
About The Position
HemaSource is looking for a detail-focused and analytical Quality Control Analyst to support the intake, evaluation, investigation, and reporting of medical device product complaints. This role directly contributes to patient safety and ensures our products meet global regulatory standards. You will be part of a highly collaborative Quality team that values accuracy, critical thinking, and a commitment to continuous improvement. If you enjoy problem-solving, working with technical data, and partnering across Quality, Engineering, and Regulatory teams, this is an excellent opportunity to grow your career in a fast-paced and mission-driven environment. You will play a vital role in supporting compliance with FDA regulations, international standards, and internal quality system requirements while helping drive improvements in product performance and customer satisfaction.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or related field.
- 2+ years of medical device complaint handling, post-market surveillance, or quality experience.
- Familiarity with FDA regulations, ISO 13485, EU MDR, and quality system requirements.
- Strong analytical, critical-thinking, and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficient with Microsoft Office; experience with QMS/ERP/complaint systems preferred.
Responsibilities
- Receive, review, and process medical device product complaints, ensuring accurate documentation and timely assessment.
- Conduct thorough complaint investigations using root-cause analysis and cross-functional input.
- Ensure compliance with FDA, ISO 13485, EU MDR, and internal quality system requirements.
- Prepare and submit required regulatory reports (MDRs, vigilance reports) within strict timelines.
- Analyze complaint data to identify trends and contribute to CAPA and continuous improvement efforts.
- Communicate clearly with internal teams and external customers regarding complaint status and findings.
- Maintain accurate, audit-ready records, complaint metrics, and documentation.
- Manage LMS activities including training assignments, system maintenance, and compliance reporting.
Benefits
- Opportunity to grow in Quality, Regulatory, or Technical Operations.
- Meaningful work that directly impacts patient safety and product quality.
- Supportive team environment with clear development pathways.
- Stable, growing company invested in compliance excellence.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
