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Senior Director of Quality Engineering and Compliance

Company: Innovative Career Resources & Staffing
Location: Aliso Viejo
Posted on: January 13, 2022

Job Description:

A Medical Device client in Orange County is looking to identify and hire a Senior Director of Quality Engineering and Compliance, on a Direct Hire basis. The Sr. Director of Quality Engineering and Compliance is responsible for leading the quality engineering department with overall responsibilities for compliance and quality engineering functions within the Quality Assurance department. The compliance responsibilities cover certification programs, recall and field safety corrective action programs, management review, external standards compliance, complaints management, and vigilance reporting management. They are also responsible for interactions with Health Authorities and Notified Bodies with respect to audits and quality system/site registrations. The Senior Director of Quality Engineering and Compliance is also responsible for leading management reviews and performing compliance activities with respect to regulations. The quality engineering responsibilities cover design assurance including Design History File compliance, process controls, good manufacturing practices, process validation support, test method validation support, equipment qualification, batch record review, and product release. The Senior Director of Quality Engineering and Compliance supports the day-to-day operations of Quality Assurance and Quality Control with respect to complaints, investigations, CAPA, training, change control, product release, etc. The Senior Director of Quality Engineering and Compliance is the Person Responsible for Regulator Compliance with respect to the Medical Device Regulation and is responsible for supplier quality and supplier audit programs.
Essential Duties & Responsibilities:

  • Lead department of quality engineers that support the development and manufacture of the light adjustable lens, light delivery device, and accessories.
  • Establish and lead processes to ensure design and process controls.
  • Compliance for audits, site registrations, and quality system certifications.
  • Lead recall and field safety corrective actions.
  • Management Review.
  • Design History File creation and support.
  • Engineering Change Request support.
  • Risk Management of products both on market and in development support.
  • Supplier qualifications and audits.
  • Assisting management with ad-hoc reports as required.
  • Completing CAPA's, complaint investigations, non-conformances, training, change controls, product releases as required.
  • Support day-to-day operations of the Quality Systems and Quality Operations groups.
  • Lead quality improvement initiatives.
  • Provide oversight of the product lines both in development and in manufacturing for compliance to relevant standards and quality system regulations including but not limited to FDA, ISO, IEC, ANSI, AAMI, CMDCAS, COFEPRIS, TGA, ANVISA, etc.
  • Run post-market compliance programs for vigilance reporting that are compliant to United States and international requirements as applicable.
  • Run post market complaint handling programs and investigations that are compliant to United States and international requirements as applicable.
  • Perform the duties of the Person Responsible for Regulatory Compliance under the Medical Device Regulation.
  • Responsible for supervising the quality engineering team consisting of any of the following:
  • Quality Engineers
  • Chemists
  • Quality Technicians/Associates
  • Scientists
  • Subject Matter Experts
  • Compliance Officers/Heads/Associates
    Requirements:
    • Minimum of Bachelor's degree in scientific or technical field (Engineering, Biology, Chemistry, etc.) with at least twelve years of experience in related field (if with a Master's degree then with at least ten years of experience in the field).
    • Training to be completed per the training plan for this position as maintained in the document control system.
    • ASQ certification recommended but not required.
    • Competent in use of spreadsheets and documents.
    • Competent in preparing presentations.
      Knowledge, Skills & Abilities:
      • Knowledgeable of intraocular lenses, ophthalmic consoles, reusable medical devices, and disposable medical devices.
      • Knowledgeable of manufacturing environment in the medical device industry.
      • Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR Part 11.
      • Knowledgeable of ISO 13485.
      • Knowledgeable of IEC 60601-1 and ISO 14971.
      • Knowledgeable of requirements for medical devices in US, EU, Mexico, Canada, Australia, and other markets.
      • Knowledgeable of vigilance reporting requirements and field safety corrective actions.
      • Able to perform product failure analysis.
      • Able to perform basic statistical analysis.
      • Able to handle conflict management and resolution.
      • Able to run complaints, CAPA, training, non-conformances, change control, engineering change requests, and other quality systems.
      • Able to speak well in front of executives for management review.
      • Able to handle multiple tasks and objectives at the same time.

Keywords: Innovative Career Resources & Staffing, Aliso Viejo , Senior Director of Quality Engineering and Compliance, Engineering , Aliso Viejo, California

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