Quality Systems and Compliance Manager

Compensation Range:

$115,000 to $125,000

Welcome to IntePros, a certified woman-owned company specializing in innovative and results-oriented recruiting and staffing solutions. We take immense pride in genuinely understanding what drives and inspires exceptional individuals like you. Your success is our priority, and we are dedicated to actively shaping your long-term career journey. At IntePros, we believe in comprehensive well-being. You have access to our medical, dental, vision, and mental health programs, ensuring your health and wellness are taken care of. To support your continuous growth, we also provide a $1,500 per year education and professional certification fund. Diversity and inclusion are cornerstones of our company ethos. IntePros is proud to be an equal opportunity employer. We do not discriminate in employment on the basis of race, color, religion, sex, pregnancy, gender identity, national origin, sexual orientation, disability, age, veteran or military status, retaliation, or any other characteristic protected by law. We celebrate the rich tapestry of backgrounds and perspectives that make us stronger as a team. Please note that only qualified individuals being considered will be contacted. We appreciate your interest and look forward to potentially embarking on a transformative journey together.

IntePros is currently looking for a Quality Systems and Compliance Manager to join one of our growing medical device clients in Kinston, NC.

Job Summary:

• Day to day planning and supervision of quality systems activities including quality systems availability, audit management, customer feedback and enterprise management system quality master data.
• Ensure continuous improvement of processes to ensure quality product and customer service.
• Representative for Global systems projects and systems upgrades
  
  
  

Essential Duties and Responsibilities:

• Site QA Manager designee for QA Systems and customer engagement activities.
• Host Customer and Regulatory audit
• Prioritize & manage available QA systems resources to ensure on time scheduling and response timelines are achieved for customer audits, notifications responses, management reviews, and customer complaints
• Ensure Kinston is represented in Global Quality System Project deployment to ensure compliance to standards and efficiency in doing business.
• Prioritize & manage available QA systems resources to ensure schedule adherence for quality reporting.
• Support validation of facilities and equipment. Approve engineering studies and other protocols as required
• Analyze data and provide reports and recommendations to management for continuous improvements
• Monitoring of trends in association of quality systems use and effectivity (Deviation, CAPA, Change Control, Periodic Documentation Review etc.)
• Ensure proper completion of Change Controls and monitor timely completion. Approve Change Controls for QA.
• Routinely evaluate employee performance and identify training needs. Provide guidance, leadership, and support to direct reports
• Review and approve work time in the appropriate time keeping system.
• Coach and counsel employees for performance, attendance and behavior. Participate in the resolution of employee relations issues.
• Exhibits regular, reliable, punctual and predictable attendance.
• Creates, prepares, implements and improves Quality Control KPIs metrics.
• Determines/sets Goals & Objectives for the Quality control organization and training programs for team's development purposes.
• Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.
• Ensures equipment is up to date on Preventive maintenance and calibration activities.
• Other duties as assigned.
  
  
  

Required

• Education: Bachelor's Degree in Technical or Engineering or equivalent experience
• Work Experience: Minimum 8 years in quality and 3+ years supervisory
  
  
  

Preferred

• KSAs
• Metrology Equipment experience
• Able to be aware of all relevant SOPs as per company policy as they are related to the position covered by the job description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company's safety and quality policies at all times