JOB OVERVIEW:

• Develop, establish and maintain QA processes, procedures and controls ensuring that performance and quality of products conform to established standards and regulations.
• Oversee the documentation process for Device History Records; propose, draft, review and approve new or revised SOPs, job instructions and related forms relative to the quality assurance program or other programs which may impact the quality assurance program.
• Provide guidance to Operations personnel in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.
• Direct and supervise daily activities of QA/QC staff involved in receiving, in-process and final inspection, complaint investigation, Corrective and Preventive Action (CAPA) process and document control to ensure compliance to quality standards/regulations.
• Responsible for Risk Management, communicating risk policies and processes for the organization.  Ensures risk management procedures are fully effective and followed throughout appropriate business tasks involving the Quality Management System.
• Responsible for hiring and training quality assurance personnel as required supporting the above processes.
• Generate ideas and leads efforts at the facility to identify root causes of quality issues and implement processes to resolve and prevent issues.
• Lead the Corrective and Preventive Action process and participate in Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other various concerned activities.
• Facilitate the Change Control Board (CCB) meetings to review and disposition Change Orders (CO).
• Lead ISO internal audit, train and develop internal auditors and issue audit reports. 
• Participate in facility and QSR inspections by the Food and Drug Administration (FDA), Notified Body and internal GMP audits.
• Evaluate employees through performance reviews, ongoing coaching and feedback methods.  Analyze and resolve or assist employees in solving work issue.  Maintain discipline, morale and team relationship within the QA/QC group.
• Provide quality data, trending/statistical reports to the RA/QA Director.
• Participates in special projects and performs other duties as required.
• Serve as the Management Representative and ensure that quality management system is established, implemented and maintained in a manner consistent with applicable quality system standards and regulations.  Report the performance of the quality management system to top management and where improvements are needed.

• Bachelor's Degree required, Master's degree preferred
• 8-10+ years of increasing responsibility in Quality related roles within the Medical Device and Life Sciences industries
• 1+ years of management experience

• Strong management and leadership skills and ability to attract, retain, motivate, develop and mentor team members for high performance.
• Outstanding verbal and written communication skills and ability to resolve disputes effectively.
• Excellent presentation and public speaking skills.
• Excellent independent decision making, analysis and problem solving skills.
• Understand and act on financial information that contributes to business profitability.
• Ability to plan and manage successful projects; understand available resources, develop timeline, budget, assign tasks and areas of responsibility.
• Lead team(s) to achieve company goals in creative and effective ways.
• Excellent planning and organizational skills and techniques.
• Communicate effectively with senior management.
• Good negotiating skills and ability to effectively manage outsourced relationships.
• Ability to influence, build relationships, understand organizational complexities and manage conflict.
• Broad professional and managerial skills with a good understanding of industry practices and company policies and procedures.
• Ability to lead virtual teams