Quality and Compliance Manager

The Quality and Compliance Manager handles the day-to-day activities of Scion’s Quality Management System (QMS) and provides valuable compliance and quality assurance insight into the full device lifecycle to make sure that all products meet consistent standards and to ensure overall quality standards are met throughout all aspects of the Company. This position is local and not remote.

• Support Operations, Clinical Affairs, Design and Manufacturing teams by addressing issues and opportunities that might arise and by establishing key quality checkpoints for new products, design and process changes, suppliers, processes, etc.
• Quality representative during design and risk management reviews, and any product or process investigation including root cause analysis and health risk assessment of the identified product or process nonconformities.
• Responsible for conducting or managing internal and supplier audits, including preparation of annual and specific audit schedules, plans, reports, and verifying subsequent corrective actions have been assigned, completed, and are effective.
• Support announced and unannounced Regulatory Body audits.
• Quality representative on non-conformance investigations regarding component failures, finished goods failures, and product returns. This includes but is not limited to performing risk analysis, determining root cause, and recommending corrective action and product disposition.
• Review product development (e.g., design verification and validation – V&V - protocols/reports), design transfer, production, and manufacturing documents and records to ensure compliance with established procedures by conducting DHF, DHR and DMR reviews.
• Manage and maintain records and document control.
• Lead and manage Corrective Action and Preventive Actions (CAPA) system. This includes, but is not limited to, identifying potential risks before they become a problem, performing risk and root cause analyses, developing corrective action plans, implementing the plan, submitting summary report for closure, and conducting effectiveness checks.
• Manage personnel training and supervise the Training Coordinator
• Manage complaint system and supervise the Complaint Coordinator (future position).
• Manage and maintain effectiveness of Company’s Quality Management System in compliance with applicable regulations (minimum US) and standards.
• Author, implement and revise, as needed, QMS procedures, work instructions, and forms to standardize and tailor documentation and activities to decrease unnecessary burden while both increasing QMS usability and effectiveness and ensuring continued compliance with current applicable standards and regulations.
• Identify Quality system improvements to encourage cross functional adoption and ownership.
• Aid with software validation planning and execution. Maintain Master Validation Plan (MVP).
• Work cross-functionally to develop Quality Key Performance Indicators (KPIs); review, track and analyze quality input across departments and provide trend analyses on a periodic basis.
• Manage and maintain applicable standards list (SL).
• Manage and maintain supplier qualifications and approved supplier list (ASL).
• Ensure compliance with QMS procedures, work instructions, plans, applicable standards, and regulations.

• Bachelor’s degree required. Higher degree a plus.
• 5-10 years Quality experience with at least 5 of those years with medical devices and 2-3 of those years managing others.
• Practical knowledge of applicable medical device regulations (minimum United States), standards (ISO 13485, ISO 14971, IEC 62304, etc.) and maintaining associated QMS.
• Practical experience with quality plan development, change control, compliance requirements for full device life-cycle records and documentation, thereof, and problem solving.
• Proficient in Risk Management per current ISO 14971
• Proficient in statistical methods, such as determination of inspection and V&V sample sizes, trending analyses, establishing confidence intervals, and calculation of process parameters.
• Willing to be hands on in small, start-up environment.
• Auditing certification and conduct experience required.
• ASQ Certification (quality engineer, six sigma) a plus
• Technical writing proficiency
• Experience working with interdisciplinary functions, including management, marketing, engineers, regulatory, clinical, and vendors. Strong communication skills and interpersonal skills allowing effective collaboration across departments are required.
• Full practical knowledge of Microsoft Office suite
• Excellent verbal and written communication skills