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Director of Quality Assurance

Responsibilities:

• 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)

Preferred Qualifications:

• 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)

For immediate consideration, please forward a copy of your current resume to info@profrecruiters.com referencing job #1684 or a link to this job.

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