Quality Assurance Specialist - Medical Device

Type: Onsite

Location: Sunnyvale, CA

Job Description:

• Regulatory Compliance:
  • Keep abreast of evolving Medical Device regulations, guidelines, and standards (e.g., FDA, ISO) to ensure our devices consistently meet compliance requirements.
  • Collaborate closely with regulatory affairs teams to facilitate accurate and timely submission of documentation for device registrations, approvals, and renewals.
• Quality Control:
  • Develop and implement rigorous quality control procedures for incoming Medical Devices, ensuring they adhere to predefined specifications and benchmarks.
  • Perform meticulous inspections and testing of Medical Devices, recording and analyzing results to identify trends, anomalies, and opportunities for enhancement.
• Supplier Quality Management:
  • Evaluate and qualify suppliers and manufacturers to ensure alignment with quality and regulatory prerequisites.
  • Conduct thorough supplier audits and assessments to ensure ongoing adherence to quality and regulatory expectations.
• Customer Complaint Management:
  • Act as the focal point for managing customer complaints related to Medical Devices.
  • Collect, investigate, and categorize customer complaints, overseeing timely resolution and ensuring effective communication with customers.
• CAPA (Corrective and Preventive Actions) Implementation:
  • Lead and support the identification and investigation of non-conformances and root causes.
  • Develop and implement effective corrective and preventive action plans to address issues and prevent recurrence.
• Documentation and Reporting:
  • Maintain meticulous and organized documentation related to Quality Assurance activities, including complaint records, inspection reports, CAPA documentation, and audit findings.
  • Prepare comprehensive quality reports detailing complaint trends, deviations, CAPA effectiveness, and risk management activities.
• Risk Management:
  • Participate actively in risk assessments to identify potential quality and safety risks associated with Medical Devices.
  • Collaborate across cross-functional teams to develop and implement risk mitigation strategies.
• Training and Continuous Improvement:
  • Provide training sessions to relevant teams on Quality Assurance protocols, procedures, and regulatory updates.
  • Proactively identify areas for process improvement and contribute to the implementation of best practices.

Qualification and Skills:

• Bachelor's degree in a relevant scientific or engineering field (e.g., Biomedical Engineering, Chemistry, Biology).
• 3+ years of Quality Assurance experience within the Medical Device sector.
• Profound knowledge of Medical Device regulations, encompassing FDA requirements and ISO standards.
• Prior experience in conducting supplier audits, quality control inspections, and customer complaint management.
• Proficiency in efficient document control and management.
• Keen analytical abilities and an unwavering attention to detail.
• Effective communication skills and adeptness in teamwork.
• Quality-related certifications (e.g., ASQ, Six Sigma) are considered advantageous.
• Fluent in Mandarin and English

Preferred Skills:

• Familiarity with the intricacies of Medical Device importation processes.
• Exposure to international regulatory bodies and standards.
• Proficiency in employing risk management methodologies.
• Comfortable with utilizing quality management software and tools.

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