Quality Assurance Manager

  • Free
  • Published date: June 22, 2020
    • Washington, United States

Summary
We are looking for a person with responsibility to develop, implement and maintain Quality Management System, which includes maintaining required regulatory certifications such as ISO 13485 and compliance to FDA 21 CFR 820. The Quality Manager is responsible for the management of supplier quality, internal audits, external audits, and keeping Executive team informed of the effectiveness of the QMS.

Essential Duties & Responsibilities
Responsible for all quality related activities within the organization, including but not limited to development and maintenance of QMS, inspection, supplier management, corrective action, preventive action, and audits required to maintain QMS requirements. Guides product development teams to ensure that Product Realization requirements, including Quality and Operational aspects are satisfied in accordance with QMS requirements.
Ensures that processes needed for the quality management system are established, documented, implemented, and maintained in accordance with QMS requirements. Develops and implements strategies to support/maintain certification/registrations.
Provide active Quality Assurance representation during the research and development process.
Keep abreast of changes to quality regulations, standards and guidance documents. Advise management of any business implications of these changes and lead the activities necessary to address the relevant changes.
Lead in the identification, development, implementation and continual improvement of quality systems across the organization. Oversee compliance processes and implement improvements.
Effectively recruit, retain and grow, and manage the QMS staff members.
Interface with FDA, and Regulatory Bodies during Company inspections. Work effectively across the organization to maintain a state of readiness for inspections by regulatory authorities and partners.
Serves as the direct liaison with auditing authorities to ensure processes are monitored, measured and analyzed to improve or maintain the effectiveness of the QMS. Implements measurable actions necessary to achieve planned results following audits.
Establish and direct completion of regularly scheduled internal audits.
Develop and implement employee communication and training programs in connection with the company’s strategic goals, quality objectives, and operational systems. Promote the recognition of quality programs within the company to create a shared continuous improvement mindset across functional departments and reinforce basic continuous improvement principles.
Ensures the promotion of awareness of customer requirements. Communicates the importance of meeting customer, statutory and regulatory requirements.
Provides the framework for establishing and reviewing quality objectives and Chairs management reviews to ensure the continuing effectiveness and suitability of the quality management system.

Qualifications/Experience
Bachelors of Science Degree from a four-year accredited college or university.
10 or more years medical device experience.
Five or more years of Supervisory or Department Lead experience in managing both processes and resources.

Job Requirements
Excellent verbal and written communication skills.
Management and performance management experience.
Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry.
Expert knowledge of 21 CFR 820, ISO 13485, ISO 14971, and Quality Assurance systems.
Medical Device industry experience.
Strong computer skills having advanced knowledge and experience with current word processing (MS Word), spreadsheet (MS Excel), graphical, and file management software.
Extremely detail-oriented with strong organizational skills and high quality standards.
Reference : Quality Assurance Manager jobs

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