Vice President of Quality Assurance

Summary:

The Vice President of Quality Assurance is responsible for designing, planning, implementing, directing, and evaluating the Quality Management System to ensure compliance is maintained with all regulations and standards, regulated activities, USA 501(k) submissions and international product approvals and registrations.


Duties and Responsibilities:

  •  Manage the Quality Assurance team to ensure it is meeting established performance expectations and provide development opportunities.
  • Develop and direct the existing Quality System to delineate areas of responsibility, personnel requirements, and operational procedures according to and consistent with company goals and policies.
  • Serve as Management Representative during audits (FDA, ISO) to ensure Quality System requirements are effectively established and maintained, and report on the performance of the Quality System to management with executive responsibility.
  • Coordinate all quality procedures (Quality Assurance manual, standard procedures, work instructions).
  • Ensure product quality meets or exceeds performance targets.
  • Ensure quality audits are conducted and are effective to ensure the Quality System is functioning as planned.
  • Manage processes related to the handling of complaints, non-conformances, and the CAPA system.
  • Create materials for and conduct quality training.
  • Complete Quality Assurance reviews of project deliverables, engineering change notices, and engineering change requests.
  • Complete and conduct routine Quality Systems effectiveness reviews and analyses.
  • All other duties, as assigned.
  • Bachelor’s degree, required. Engineering degree, preferred.

  • Expert level experience with ISO 13485 and FDA QSR, required.

  • General understanding of ICH, cCHP, cGMP, cGDP, FDA, MDD, ISO, healthcare compliance and applicable regulations and industry standards regarding clinical research and regulations of medical devices, required.

  • Strong leadership and interpersonal communication skills, required.

  • Self-motivated with a proactive attitude and the ability to work independently.

  • Familiar with departmental policies, SOPs, goals, and objectives.

  • Strong problem-solving and decision-making skills, required.

  • Strong written and oral communication skills, required.

  • Strong analytical and troubleshooting skills, required.

  • Strong organizational and project management skills.

  • Strong team mentality and management, required.

  • Computer proficiency (Microsoft Office Suite, SharePoint).

  • Minimum of 10 years of quality system design and implementation experience in the medical device industry.

  • Experience wtih Quality Assurance for class 2 medical devices, specifically in the diganostic imaging field or ultrasound field.

Full-Time
Vice President of Quality Assurance
Charlotte, NC
open
2016-10-10
2017-10-10
Human Resources
HR@sonacaremedical.com

HIFU company

Contact

10130 Perimeter Pkwy, Suite 250
      Charlotte, NC 28216

(888) 874-4384

info@SonaCareMedical.com

Mon - Fri: 9:00 - 5:00

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