
Sterile Medical Devices Quality Assurance Professional
2 days ago
The Quality Assurance Specialist plays a pivotal role in ensuring that our organization's sterile medical devices meet the highest standards of quality, safety, and regulatory compliance.
- Supervise team members in performing inspections of sterile medical devices and components to ensure adherence to established protocols.
- Conduct sampling, testing, and documentation of raw materials, packaging materials, finished goods, and sales return products.
- Investigate customer complaints, prepare investigation reports, and implement corrective actions as necessary.
- Ensure compliance with applicable regulatory standards, including ISO 13485 and IMDR.
- Maintain and calibrate quality control instruments and equipment to guarantee accuracy and reliability.
- Prepare and review quality documentation, including SOPs, inspection reports, COAs, and deviation reports.
- Participate in internal audits and support external regulatory inspections to maintain credibility and trust.
- Identify and report non-conformities, assist in root cause analysis, and collaborate on CAPA implementation.
Qualifications & Skills:
- Bachelor's degree in Science, Engineering, Pharmacy, or a related field.
- 4-6 years of experience in quality control within the medical device industry.
- Familiarity with GMP, ISO 13485, and IMDR regulations.
- Proficient in using quality control tools and instruments.
- Strong documentation and analytical skills.
- Excellent communication and teamwork abilities.
- Experience with statistical quality control (SQC) and SPC tools.
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