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Quality Assurance Manager

2 months ago

King of Prussia, Pennsylvania, United States Camber Spine Full time
Job Title: Quality Assurance Manager

Camber Spine is seeking a highly skilled Quality Assurance Manager to lead the quality and regulatory department. The successful candidate will be responsible for planning, coordinating, and managing quality assurance activities associated with all quality management system requirements.

Key Responsibilities:
  • Manage the quality and regulatory department's strategy, resources, and activities.
  • Lead internal and external audits, including notified body audits, and participate in supplier audits.
  • Oversee and manage supplier control activities, conduct management review meetings, and oversee trending documentation.
  • Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.
  • Lead teams for Risk Management activities for new and/or modified products and processes, including risk assessment, authoring risk management plans and reports, and facilitating risk assessment activities.
  • Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Generate internal quality documentation, such as quality plans, standard operating procedures, and inspection procedures.
  • Participate in Quality Review Boards, identify non-conformance trends, and develop technical investigation plans.
  • Monitor field quality, analyze field returns, and determine root cause.
  • Provide training and support for quality system processes and quality engineering practices.
  • Support tissue banking activities as deemed necessary to meet regulatory requirements.
  • Support regulatory submissions.
Requirements:
  • BS/BA in Engineering, life sciences, or a similar field.
  • 8-10 years of experience in medical device quality assurance or engineering.
  • Demonstrated working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and other related medical device standards.
  • Experience working per 21 CFR Part 1271 and applicable state licensing requirements preferred, but not required.
  • Self-motivated and able to balance multiple priorities and tight deadlines with minimal supervision.
  • Excellent communication skills – verbal and written.