Quality Assurance Specialist
3 days ago
Job Title: Quality Assurance Specialist
Company Overview: Stirling Q&R is a leading company in the medical device industry, dedicated to delivering innovative solutions that enhance patient care. We are seeking a detail-oriented Quality Assurance Specialist to ensure our products meet the highest quality standards and regulatory requirements.
Key Responsibilities:
- Develop and implement quality assurance protocols and standards to ensure product compliance.
- Conduct risk assessments and failure mode effects analysis (FMEA) for new and existing products.
- Perform root cause analysis on product defects and nonconformities, driving corrective and preventive actions.
- Collaborate with manufacturing and engineering teams to optimize production processes for quality.
- Document all quality activities and maintain accurate records.
Requirements:
- Bachelor's degree in Engineering, Quality Assurance, or a related field.
- 2-4 years of experience in quality engineering within the medical device or related industry.
- Knowledge of quality management systems, ISO 13485, FDA regulations, and process validation.
- Proficient in Microsoft Office Suite and quality management software.
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