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Quality Assurance Manager

Company: Orthotic Holdings Inc. (OHI)
Location: Mesa
Posted on: November 22, 2022

Job Description:

Job Summary: The Manager of Quality Assurance and Regulatory Affairs is responsible to lead the resolution of quality and compliance issues within the business and provide routine quality feedback and continuous improvement leadership to cross functional groups. The Manager of QA/RA will also serve as OHI's Management Representative with Regulated bodies such as FDA, Health Canada, EU MDR competent authorities, and take the lead role in ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of applicable regulatory agencies.
Essential Duties and Responsibilities:Regulatory Affairs

  • Responsible for maintaining site and product registrations with FDA, Health Canada and EU MDR competent authorities
  • Maintain an understanding of regulatory compliance requirements and changes as mandated by the countries we operate in and sell to
  • Lead and facilitate site regulatory inspections Quality Assurance and Compliance
    • Responsible for developing and monitoring the complaint management process.
    • Interact with management and, if appropriate, regulatory and governmental agencies to ensure that quality systems are adequate, and facilities are compliant.
    • Ensure FDA and Health Canada compliance
    • Develop a quality scorecard for OHI and report monthly on results and action plans and present quarterly to facilitate a management review
    • Conduct site and department audits with formal reporting of audit results and resolution tracking to issue closure to proactively identify compliance issues Quality Operations
      • Facilitate and manage all required quality and regulatory training of staff
      • Ensure work instructions and workmanship standards are suitable to ensure product safety and effectiveness
      • Investigate quality complaint and internal non-conformance trends and issue Corrective and Preventative Action (CAPA) requests to appropriate functional teams
      • Maintain individual skills keeping up to date with the latest quality management concepts e.g. TQM/Six Sigma/Design of Experiments Qualifications and Requirements:
        • Successful candidate should have 5+years QARA/Compliance experience in a Class 1 or 2 medical device manufacturing environment
        • Experience in developing and maintaining quality systems and manuals to meet FDA, Health Canada and EU site and product registrations
        • Track record of successful FDA and/or ISO 13485 audits
        • Excellent understanding of quality principles, industry practices, and standards with demonstrated ability to apply these to OHI operations
        • Ability to identify compliance issues and partner with other parts of the organization on a path for resolution
        • Strong analytical skills, data-driven, flexible, and hands-on
        • Experience delivering effective presentations and training programs
        • Excellent interpersonal skills, leadership and diplomacy, builds strong relationships with cross-functional colleagues
        • Self-motivated, proactive, dependable, honest, and thorough
        • Strong project management, organizational, and communication skills are required
        • Proven experience writing SOPs and workmanship standards
        • Experience and knowledge of Good Manufacturing Practices is a plus
        • Familiarity with OSHA and TQM/Lean Six sigma experience is a plus
        • BS/BA degree preferred OHI is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information

Keywords: Orthotic Holdings Inc. (OHI), Mesa , Quality Assurance Manager, Executive , Mesa, Arizona

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