The Quality Manager is responsible for the Quality Management Systems to assure product specifications are met for all Catalyst OrthoScience products. This position will lead all Quality functions within the organization and participate on cross-functional project teams. This position will be responsible to maintain the QMS, facilitate external and internal audits, ensure completion of nonconformances, CAPA’s, complaints, document control and change controls.

Position Responsibilities:

 

• For document control, maintain all records within the QMS, route engineering change orders and other records for appropriate approvals.
• Maintain QMS procedures to ensure compliance with current regulations and propose updates as required.
• Oversee all QMS training for new employees or for updates made to the QMS.
• Assist with the creation, maintenance, and performance of QMS tools: CAPAs, NCMRs, Complaints, Recalls, etc.
• Perform supplier evaluations and maintain Approved Supplier List, which includes scheduling of audits as required.
• Review all Device History Records (DHR) and approve prior to product release.
• Complete regulatory assessment of all engineering change orders and potential impact to regulatory requirements.
• Provide input into Management Review activities.
• Documentation review for design changes, risk assessment, DHR maintenance, etc.
  Qualifications: 
• 3 - 5 years related experience in quality assurance and / or regulatory affairs.
• Bachelor’s degree in life sciences, engineering, or equivalent education and technical knowledge.
• Knowledgeable of FDA Part 820 and ISO 13485 requirements. • Knowledge and understanding of quality management system principles and practices.
• Experience working with US FDA and International Regulatory Bodies on product submissions.
• Demonstrates ability to work effectively in a team based environment with proven ability to be flexible and adaptable.
• Excellent communication skills: written and oral