
Medical Device Quality Specialist
1 day ago
Job Title: Medical Device Quality Specialist
"Empowering Quality Excellence"
We are seeking a highly skilled Medical Device Quality Specialist to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the highest standards of quality and compliance in our medical device products.
Key Responsibilities:
Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.
Evaluate complaints for severity and risk, ensuring timely review and processing.
Prioritize and enter complaints into the global database, monitoring complaint activity for assigned regions/countries/manufacturing sites.
Conduct thorough analyses to identify the root causes of defects reported in customer complaints, utilizing IT tools for data accuracy.
Comprehensive review of batch records, correlating relevant manufacturing data with quality events and deviations to elucidate reported defects.
Collaborate with production and laboratory departments to gather comprehensive field data for investigations.
Focus on operational tasks within the compliant handling process.
Ensure qualitative, GMP-compliant processing of the complaint process.
Focus on independent, function-specific duties and responsibilities.
Requirements:
1-3 years of related experience in the pharmaceutical industry.
Knowledgeable in Quality functions of pharmaceutical industry.
Preferred Skills:
Proficient in problem-solving, attention to detail, and good organizational skills.
Ability to work in a team-oriented, flexible, and proactive manner.
Analytical skills and ability to multitask in a stressful environment.
Education:
Bachelor's or Master's in Life Sciences/Healthcare, Business Administration, Engineering, or Information Technology.
"Highly motivated individuals are encouraged to apply for this challenging and rewarding opportunity."
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