
Senior Quality Compliance Specialist
4 days ago
This is a quality assurance specialist role that focuses on ensuring regulatory standards are met and product quality is continuously improved. The ideal candidate will have strong analytical and problem-solving skills, as well as excellent written and verbal communication skills.
Main Responsibilities:
- Investigate customer complaints to identify root causes and ensure timely resolution in compliance with FDA regulations.
- Develop and implement corrective actions to mitigate identified risks and prevent recurrence of quality issues.
- Analyze data related to product performance, complaints, and process deviations; present findings in a clear and actionable manner.
- Author and maintain high-quality technical documentation, including investigation reports, risk assessments, and trend analyses.
- Collaborate closely with cross-functional teams to drive resolution of quality issues and ensure compliance with internal and external standards.
The ideal candidate will have a solid understanding of FDA QSR and relevant international regulations. A bachelor's degree in Engineering or Life Sciences, 5-8 years quality assurance experience in the medical device industry, or 3 years experience in a similar role with a relevant level nine qualification is required.
Preferred Qualifications:
- Six Sigma or Lean Certification.
- Knowledge of EU MDR and international medical device regulations.
- Strong attention to detail and commitment to quality.
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