Quality Control Manager

The Quality Control Manager for IVD Products will be responsible for the design, development, implementation, and continuous improvement of quality processes and global procedures to ensure compliance with internal and external quality and regulatory requirements. This role involves managing and coordinating safety, quality, execution, and continuous improvement activities within the Quality Control department, with a focus on IVD products.

Job Responsibilities:

• Design, develop, implement, maintain, and continuously improve quality processes and global procedures to ensure compliance with applicable internal and external quality and regulatory requirements.
• Manage and coordinate the safety, quality, execution, and continuous improvement activities of the Quality Control for IVD products.
• Establish, maintain, and report on quality metrics for product complaints and investigations, making recommendations where trends are realized.
• Collaborate with New Product Development to manage complaint handling for new product launches and provide Quality oversight of design changes where appropriate.
• Collaborate with the Post Market Surveillance team to ensure existing and new product complaint data is delivered and represented in the Product Surveillance Reports.
• Conduct clinical trials / performance studies, compile and analyze data, prepare technical documents and reports in compliance with internal standards, IVDR and FDA regulatory requirements.
• Responsible for incoming Quality Control of materials and the functional release testing of finished goods with batch record review and release.
• Monitor and evaluate the performance of medical devices.
• Perform testing to generate data for the lot-specific calibration.
• Perform studies to access the accuracy, precision, sensitivity and stability for new products.
• QC for product-related components and biological reagents.

Qualifications:

• BS or MSc in Life Sciences field. 5+ years of proven track record in medical device or IVD experience.
• Proficient and experienced in ISO13485 and IVDR. Working knowledge of FDA 21 CFR regulations.
• Solid understanding in all aspects of lab testing/Quality Control and Quality Management Systems.
• Highly technical and possess an acute attention to detail to ensure Affimedix continually meets deliverables in a timely and compliant manner.
• Good communication and interpersonal skills, as the role involves working with other team members.
• Good attention to detail and ability to work accurately and efficiently. Strong analytical, problem-solving and documentation skills.

Compensation:

Highly competitive package commensurate with experience.