Description

As a Senior Quality Manager, you will lead efforts to enhance quality processes, collaborate across departments, and ensure compliance with regulations. This role involves managing investigations, developing talent, and driving team engagement to meet quality objectives.

Requirements

• •Knowledge of regulatory requirements, including ISO, FDA, and International requirements
• •Technical knowledge of medical device product lines
• •Written, verbal, listening, communication, and team-building skills
• •Ability to collaborate effectively and lead cross-functional teams
• •Ability to prioritize and manage multiple project workloads
• •Experience with trending and analysis reporting
• •Knowledge of adverse event reporting, complaint investigation, CAPA, and corrective action processes
• •Leadership skills
• •Process improvement and management skills
• •Experience with recruiting and people development
• •Influence across the organization
• •Entrepreneurial spirit for driving business forward
• •Accountability for collaborating with global colleagues
• •Predisposition for coaching and mentoring
• •Strong emotional intelligence
• •Exceptional communication skills to influence decision makers
• •Great interpersonal skills and teamwork
• •Strong leadership skills for team engagement
• •Service-minded and courageous
• •BS in a science, engineering or related field; advanced degree preferred
• •Minimum of 10 years experience, 7 years of supervisory experience preferred
• •Masters Degree or equivalent preferred
• •Experience working in a regulated environment
• •Good understanding of manufacturing process technologies
• •Experience with delivering results through 6 sigma and lean methods
• •Strong analytical ability and relevant ERP knowledge (preferably SAP, Oracle or JDEdwards)

Tasks

• •Establish a quality center of excellence
• •Develop organizational strategies and processes
• •Set goals and metrics for quality improvements
• •Oversee consistency of quality processes
• •Manage product and safety investigations
• •Evaluate day-to-day quality processes
• •Establish annual budgets and quarterly forecasts
• •Collaborate with various departments to meet corporate goals
• •Develop teams for timely resolution of technical issues
• •Serve as a site leader for GQO quality processes
• •Provide guidance on regulatory requirements
• •Establish processes for task resolution management
• •Chair meetings to drive closure of quality issues
• •Manage and update quality metrics
• •Represent quality processes during audits
• •Define targets and KPIs for team members
• •Recruit and onboard top talent
• •Develop team talent to enhance performance
• •Maintain high team engagement levels

Tools & Technologies