Sr. Quality Control Manager

Job Title: Senior Quality Control Manager

Job Summary:
The Senior Quality Control Manager will be responsible for overseeing the quality control processes across all stages of product development, from manufacturing to final testing and release. The role involves managing a team of quality control specialists, ensuring compliance with regulatory standards, and continuously improving quality processes to maintain product integrity and customer satisfaction. This position is key to ensuring the safety, reliability, and performance of our diagnostic products.

Key Responsibilities:

• Quality Oversight: Lead and manage the overall quality control strategy, ensuring all diagnostic products meet internal and external standards, including regulatory requirements (FDA, ISO, CE, etc.).

• Team Leadership: Supervise, mentor, and develop a team of quality control specialists. Provide direction, training, and guidance on quality processes, testing methods, and troubleshooting.

• Quality Control Processes: Design and implement quality control procedures, inspection protocols, and validation processes to ensure product consistency and compliance.

• Regulatory Compliance: Ensure all products meet relevant regulatory standards and certifications. Lead audits and inspections by regulatory bodies, preparing for internal and external audits.

• Problem Resolution: Investigate quality issues, perform root cause analysis, and lead corrective and preventive action (CAPA) processes to resolve non-conformances.

• Data Analysis & Reporting: Analyze quality control data and metrics, report trends, and provide actionable insights to senior leadership for continuous improvement. Develop and present regular reports on quality control performance.

• Process Improvement: Drive continuous improvement initiatives within the quality control department. Evaluate and enhance testing methodologies, equipment, and software tools to improve overall product quality.

• Collaboration: Work cross-functionally with R&D, manufacturing, and regulatory teams to ensure product quality is maintained throughout the product lifecycle.

• Documentation: Ensure proper documentation of all quality control activities, including test results, investigations, and CAPA implementation. Maintain accurate records in accordance with industry regulations.

Qualifications:

• Education: Bachelor's degree in Life Sciences, Engineering, or a related field. A Master's degree is a plus.

• Experience: 8+ years of experience in quality control within the diagnostics or medical device industry, with at least 3 years in a managerial or leadership role.

• Certifications: Certification in Quality Control (CQE, CQA, or equivalent) is highly preferred.

• Knowledge: Strong knowledge of regulatory standards (FDA, ISO 13485, CE marking), product testing methods, and quality control tools and techniques.

• Skills:

  • Strong leadership, communication, and interpersonal skills.

  • Proficient in quality management software and data analysis tools.

  • Excellent problem-solving abilities with a keen eye for detail.

  • Ability to work in a fast-paced, dynamic environment while maintaining a high standard of work.

  • Strong project management skills with the ability to prioritize and manage multiple tasks.