This candidate will lead the quality function at Syncell Inc, ensuring compliance to all applicable quality, customer, and regulatory requirements. As a key member of the site leadership team, this individual will provide the strategic direction to top management and perform the necessary oversight to achieve establishment and full implementation of the site Quality Management System (QMS). Responsible for establishing, leading and managing the Quality Team to support site operational performance and meet business needs. QMS site representative, leader for all regulatory and customer audits/inspections and contact person for QMS compliance issues.
Responsibility:
• Establish and maintain the company’s quality system, provide quality expertise and guide Quality department to effectively meet or exceed goals and target.
• Collaborate with the various functions to ensure the quality management system is comprehensive, incorporates standard processes, and is consistent with the strategic plan.
• Collaborate with cross-functional teams to formulate product inspection plans and ensure compliance with quality standards.
• Product Development responsibilities including design controls, risk management, document control and record management, and supplier management.
• Manufacturing responsibilities including process controls, labeling, change control/management, and CAPA.
• Responsible for monitoring and measurement including validations, calibrations, customer feedback and complaints, Post Market Surveillance, internal audits.
• Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Set goals which align to department plans and be responsible for the execution of goals through coaching and mentoring.
• Ensure continuous improvement through the Practical Process Improvement (PPI)
• Ensure corporate, regulatory, and division quality requirements are met.
• Ensure customer expectations are met or exceeded.
Qualifications:
• Bachelor of Science Degree in – Life Sciences, Engineering or related science/engineering degree preferred.
• 10+ years of professional quality experience – Site quality leadership experience preferred.
• Understanding of the Life Sciences or IVD/Medical Devices industries and required compliance regulations for products and processes.
• Solid understanding and experience with ISO 9001/ISO 13485 standards
• Experience in MDSAP, IVD/IVDR, 510K and GxP requirements is a plus.
• Deep knowledge and experience implementing the following: Design and Process FMEA’s (Failure Mode Effects Analysis), CAPA (Corrective and Preventive Actions) process, Design Transfer, V&V, Complaints Handling process, Change Control/Management process, Post Market Surveillance
Other Skills
• Effective as a valued team member and colleague with leaders at all levels
• Experience working and providing customer support, investigations, and relationship management.
• Confirmed communication and internal/external customer management skills.
• Experience supporting change management efforts.
• Confirmed people leadership skills to build out the successful team.
• Demonstrates personal awareness and desire for continual learning and personal development.
• Hands-on and productive - Normally receives little instruction on day-to-day work, general instructions on new assignments.
• Must possess the presentation skills and integrity to project a professional image, both internally and externally
• Strong interpersonal, verbal and written communications skills are crucial.
