Quality System Director - Sun Nuclear Corporation - Melbourne

Job description
Job Summary: The Quality System Director is responsible for leading a quality culture and management system of good and desired practices and ensuring compliance with international quality systems.
Key Areas of Responsibility:
Ensure quality system compliance with national and international standards, regulations and legislation in all applicable markets; including, and not limited to, applicable revisions of ISO 13485, CMDCAS, CE/MDD, FDA, SFDA (China), ANVISA (Brazil) and Environmental Health and Safety standards.
Ensure quality processes and practices are effective and up to date by incorporating both theory and proven best practices with a discrete understanding of company’s industry, products, competencies and opportunities for improvement. Quality processes include: CAPA, complaint handling, internal audit and post market surveillance.
Direct the company’s quality management system.
Serve as the Company’s Management Representative.
Plan, develop and implement strategies and tactics to support corporate objectives and build an effective quality culture.
Provide quality training and internal quality communications company-wide.
Serve as audit escort for external quality system audits.

Lead and maintain effective internal quality audits, including finding tracking and closure.
Maintain an effective CAPA system for the company
Ensure that the Corporate Management System (CMS) and continual improvement system are up to date and effective.
Coordinate Management Reviews and report on performance, health and effectiveness of the CMS.
Interpret documents of significant complexity, including external standards, design inputs and V&V protocols.

People and Systems:
Guarantee proper resource planning for Quality Assurance people and systems based on strategic initiatives, trends in work levels as well as changes in quality and regulatory activities.
Provide leadership, mentoring conflict management and development to team members and others as needed.

Desired Skills and Experience
Skills & Experience:
Effective communication and presentation skills, both oral and written (must be fluent in English)
Strong interpersonal skills (must be able to function well with all corporate divisions)
12+ years of experience in medical device industry quality assurance.
Fluent knowledge of ISO 13485, FDA21 CFR 820, EC MDD 93/42, and/or CA SOR 98/282.
Prior responsibility for a CAPA system
Prior responsibility for an internal audit system
6+ years experience in successful people management

Academic & Industry Requirements:
MBA and/or MS in Quality or technical field preferred.
Professional certification from the American Society for Quality (ASQ) is preferred.
Up to 30% travel required between Melbourne, FL and Madison, WI company locations.

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