QA/RA Manager

Establish an overall strategic plan for the Quality Assurance, Quality Control, and Regulatory Affairs Departments, and manage the execution of all efforts targeted at fulfilling strategy.

Coordinate with other departments, corporate or marketing partners and international offices to achieve goals.

Establish budgets for the QA/RA departments, as well as primary input to product development program budgets, as it relates to quality, regulatory and safety agency issues.

Manage departmental expenses in keeping with established and approved budget.

Establish and nurture a skilled, flexible, efficient work force capable of developing, implementing, and meeting program goals and objectives.

Direct the departments’ personnel administration activities including job assignment, training, performance evaluation, and compensation review.

Provide leadership and personal involvement in Lean Manufacturing initiatives and other Continuous Improvement initiatives throughout the operation.

Must have thorough knowledge of FDA and relevant safety agency guidelines and requirements.

Expertise in establishing and managing a Quality Management System with compliance to ISO 13485:2003

Demonstrated exemplary leadership, organization, and strategic/tactical qualities.

Ability to foster an organizational culture that is based on cross-functional collaboration, support and constructive feedback.

Ability to perform in a proactive, self-motivated fashion.

Ability to build high performance teams.

Ability to manage multiple concurrent projects and effectively motivate staff.

Strong presentation skills up to and including Sector President level.

Ability to manage departmental resources assigned to achieve objectives and initiatives – on time and within budget.
REQUIREMENTS
BS/BA degree

5 plus years leadership experience in a professional and successful medical devices environment, including new product development and manufacturing.

Advanced technical or business degree preferred.

QA 80% and RA 20%

Experience with electro-mechanical, software based medical devices required.

Experience in imaging/patient monitoring technology preferred.

Please advise present/last salary and day time phone number.