• Provide quality system leadership to assure internal policies, customer expectations, and regulatory requirements are met.
•Lead the Quality Management System for an ISO 13485 plant registered with the FDA as a medical device manufacturer of Class 1 and Class 2 Devices (21 CFR part 820).
•Closely partner with key pharmaceutical customers to adopt the management system and manufacturing methods to meet aseptic manufacturing standards and applicable 21 CFR part 210/211 and EU requirements.
•Manage the site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibrations maintenance, validation, internal auditing, training, R&D transfers, and manufacturing area support.
•Actively manage the Quality Control team performance to meet standard turnaround times. QC test first pass yield (test/retest error), and labor efficiency.
•Closely partner with the Global Design Quality Assurance organization to drive robust design transfer and long term new product introduction success.
•Set site wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality System.
•Ensure site wide training is effective and that the plant operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective.
•Provide significant knowledge and insight into qualification and validation activities and the ability to work effectively with engineering and operations teams in completing these tasks.
•Drive a culture of continuous improvement by employing Practical Process Improvement concepts.
•Manage the metrics and tier system escalations and reporting.
• Bachelor’s degree from accredited college/university or equivalent experience, Preferred Science or Engineer Degree
• Minimum of 8-10 years of relevant experience in Medical device or Pharmaceutical industry including 2 years in a supervisory or managerial position
•Expert knowledge of quality standards (e.g., 21 CFR Part 820, ISO 13485 9001 regulations)
• Bachelor’s degree in Engineering, Chemistry or Biology
• Project Management experience (1 - 3 years)
• Certified Lean Professional or Six Sigma Black Belt (1 – 3 years)