What are the responsibilities and job description for the Quality Engineer position at Dizario Search?
Dizario Search is partnering with a growing medical device manufacturer committed to delivering high-quality products that support healthcare professionals and improve patient outcomes. As they continue to expand, they are seeking a Quality Engineer to join their team.
The Quality Engineer will play a key role in maintaining and enhancing the Quality Management System (QMS), ensuring regulatory compliance, and driving continuous improvement initiatives across manufacturing operations.
Key Responsibilities
- Support and maintain compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory requirements
- Lead investigations related to nonconforming products, deviations, customer complaints, and CAPA activities
- Conduct root cause analysis using tools such as 5 Whys, Fishbone Diagrams, and Failure Analysis techniques
- Participate in internal and external audits, including supplier audits and regulatory inspections.
- Analyze quality metrics and identify opportunities for continuous improvement
- Review and approve manufacturing documentation, procedures, and quality records
- Support process validation activities including IQ, OQ, and PQ protocols
Qualifications
- Bachelor's degree in Engineering, Quality, or a related technical field
- 2 years of Quality Engineering experience in a regulated manufacturing environment or injection molding
- Experience with FDA regulations and ISO 13485 requirements
- Strong understanding of CAPA, NCR, root cause analysis, and risk management methodologies
- Excellent analytical, problem-solving, and communication skills
Salary : $85,000 - $105,000