Medical Device Quality Specialist

1 day ago


Hyderabad Secunderabad Telangana, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878

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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