Senior Manager, Quality Systems

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
The Senior Manager, Quality Systems is responsible for developing, defining and directing the quality systems. This role is responsible to ensure the Quality Management System is established, implemented, and maintained. In addition, the Senior Manager Quality Systems is responsible for reporting the performance of the Quality Management System to clients leadership team.

Primary Responsibilities

• As the leader of Client quality management system, the incumbent will be responsible to ensure the overall quality management system is implemented across Client in accordance with applicable regulatory requirements, including but not limited to FDA, EU MDR, other regulatory bodies.
• As the Center of Excellence Lead and Business Process Owner, drives the end-to-end process for Document Control, Change Control, Training, CAPA, Non-conformances, Complaint Handling, & Risk Management, & with process improvement efforts and ensuring compliance to regulations.
• Oversight of Centers of Excellence related to training, document control, and regulatory watch processes and other areas as needed.
• Work closely with the development and manufacturing groups to ensure that our processes and procedures are followed along with meeting regulatory compliance.
• Works with the cross-functional teams in development, review and approval of validation protocols and reports.
• Development, distribution and monitoring of global QA/RA KPIs.
• Leads the team as a people manager, motivating the team, mentoring, and ensuring through good leadership that defined performance outcomes are ensured.


• Complaint Management


• Manages the end-to-end complaint workflow and the processing of complaints.
• Working cross-functionally, oversees processes for customer related product and/or complaint investigations, corrective/preventive action, customer contact, inventory analysis, and product returns.
• Working with the cross-functional teams, ensures accurate complaint/return data integrity to facilitate trending of complaints and service issues.
• Collect data, prepare presentations related to complaint KPIs.
• Perform training and instructional guidance regarding complaint handling processes to business process experts.


• Key Performance Indicators


• Responsible for developing and implementation of time driven and uniform KPIs across Client. 
• Ensure functional area processes reflect adequate KPIs to sustain QMS processes.
• Analyzes medical device QMS data to identify trends and notify designated internal personnel with the findings and recommendations
• Compiling presentation for weekly, monthly, and quarterly reviews for the leadership team


• Change Control/Document Control


• Responsible for the development, implementation and maintenance of global end-to-end Change Management and Document Control processes including:
• Approval
• Planning
• Impact assessments
• Implementation


• Training


• Responsible for the development, implementation and maintenance of the end-to-end Training process. 
• Responsible for working with the cross-functional teams in identifying role-based training requirements, implementing training matrices and, curricula, delivering training and ensuring our training program is compliant through development of KPIs and monitoring.


• Oversight of the following systems


• Change Control
• Document Control
• Training
• CAPA
• Non-Conformances
• Complaint Handling
• Risk Management


• Other


• Interacts with all departments and levels.
• Assures that the duties, responsibilities, and authority of each job in his/her area of influence are clearly defined and effectively communicated to incumbents.
• Manages personnel within group with responsibilities to include staffing, performance management, development and coaching, training, and application of policies, programs, and procedures.  Assures that a positive employee relations environment is maintained through effective commun