Quality Manager

1 week ago

Republic, United States Enhance Recruiting Full time
Job DescriptionJob Description

SUMMARY:

We are seeking a Quality Manager for a global medical manufacturing leader. This highly visible role will be responsible for developing and implementing a strong culture of Quality across all departments within the facility to facilitate and support growth. This manager will create procedures and processes on the ground floor level to ensure successful compliance with Medical Regulations and Requirements. If you are seeking to have a meaningful role that impacts patients' lives and you want to make a difference, this is your chance. Apply here

RESPONSIBILITIES:

  • Quality Management System oversight including reporting and Process Improvement.
  • Ensure ongoing compliance with FDA requirements while improving and optimizing the quality system and transitioning to ISO 13485.
  • Ensure the facility can deliver high-quality products to customers by working with various departments to reduce in-process defects, customer complaints, and recalls.
  • Lead and oversee Supplier Qualifications, Internal Audits, and CAPA Management.
  • Establish and maintain a Quality Management System compliant with 21 CFR Part 820. Review and approve quality system documents, reports, and records.
  • Ensure Quality Records are established, in compliance, and available, including electronic records and signatures.
  • Ensure adequate Process Controls and Quality Controls are defined and implemented throughout the production process to ensure customer and regulatory requirements are met.
  • Collect, analyze, and trend quality data. Provide quality performance data for reports and provide evidence-based recommendations for process improvements.
  • Supervise Quality Assurance Technicians and Quality Control Technicians.

REQUIREMENTS:

  • BA/BS in sciences, engineering preferred.
  • 5+ years of experience in the medical device industry.
  • 2+ years of experience in a supervisory or management role
  • Experience with Quality System Requirements and Regulations in the medical device manufacturing industry.

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