Quality Assurance Manager (IVD / Lateral Flow POCT)

Quality Assurance Manager (IVD / Lateral Flow POCT)

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Job Description

The Quality Assurance Manager (IVD/POCT) will support the In-vitro Diagnostics and Lateral Flow Point-of-Care Testing department by leading hands-on the IVD/POCT Design Control process from feasibility through manufacturing/ EUA release, while ensuring procedural and regulatory compliance. The QA Manager(IVD/POCT) will support continuous improvement, and on-going development of the Quality Management System, and support ISO 13485 certification. The QA Manager(IVD/POCT) will be responsible for IVD/POCT Quality reporting, CAPAs, validations, specification development, NCM reporting, internal and external audits, and IVD/POCT regulatory reporting and compliance domestically and internationally with cross-functional support.

• Oversee aspects of the quality management system and support documentation and processes specific to IVD/POCT
• Lead IVD/POCT Design Control
• Report to Management on the performance of the quality management system and any need for improvement
• Recruit, lead, manage, and develop the Quality Assurance (IVD/POCT) staff including responsibilities for selection, coaching, performance management, and talent development of the team
• Evaluate and sign off on IVD/POCT CAPAs, quality plans, documentation, customer complaints, audits, validations, training, NCMRs and other quality feedback mechanisms
• Review product documentation and records, including quality control test results, as needed for the release of product
• Develop product and process inspection plans and criteria
• Recognize and handle product, process and quality system nonconformities
• Maintain an in-depth understanding of the quality and documentation systems, applicable standards and requirements
• Monitor process controls associated with all IVD/POCT business functions to ensure compliance with the requirements and intent of the established ISO quality system
• Maintain an awareness of Regulatory Affairs (FDA EUA, relevant domestic and international regulations)as it relates to and impacts IVD/POCT manufacturing and distribution, including the requirements for vigilance reporting
• Support and approve audits: internal, external, and supplier
• Conduct quality system training for company and IVD/POCT department personnel as required to comply with quality system requirements
• Review IVD/POCT product documentation and records, including quality control test results, as needed (for the release of product
• Recognize and handle product, process and quality system nonconformities

Qualifications

• Bachelor's degree in business, science, or related technical field
• 7 years' In-vitro Diagnostics / Point-of-Care Testingindustry experience a must
• 7 years’ experience in Quality related systems
• At least 3 years of experience managing a team
• Ability to collaborate and communicate effectively within cross-functional teams
• Solid knowledge and experience with electronic quality system management software
• Ability to effectively prioritize, managing multiple projects with overlapping timelines
• Solid communication, decision-making, and organizational skills
• Ability to think critically and problem solve
• Ability to think strategically, and work tactically on multiple concurrent projects
• Computer proficiency with Microsoft Office products required
• Work Remotely: temporarily as a result ofCOVID-19; 50% required on-site

Additional Information

Qualified candidates should submit a resume and cover letter. The cover letter should include information on how your previous experience relates to the job requirements and your availability. Specific examples are of interest. You will not be considered without a cover letter.

All your information will be kept confidential according to EEO guidelines.