Medtronic Sr. Design Quality Assurance Manager in Industrial Zone, Israel
Sr. Design Quality Assurance Manager
Yokneam, Industrial Zone, HaTsafon, Israel
Apr 05, 2017
The Manager of Quality Design, as a member of the Early Technologies Design Quality leadership team will report directly to the Vice President of Quality and Regulatory Affairs (QRA), Early Technologies.
This individual will be responsible to manage the quality design department activities in support of departmental, functional, business, group, and corporate quality goals and priorities. The Quality Design department provides focused quality engineering support for new and existing products for global distribution.
They are responsible for ensuring that all products designed and manufactured within GI Solutions meet company, regulatory, quality, and customer requirements.
The Manager of Quality Design manages all aspects of the Quality Design Department at the GI Solutions’ Yokneam. This person communicates directly with product development site leadership on quality design strategy, and reports quality issues and development status to the Vice President of Quality and Regulatory Affairs, Early Technologies and the GI Solutions site leadership. This person is responsible for design strategy and managing tactical execution within the Quality Department for new product development and sustaining business activities.
Key Job Responsibilities:
·Has direct responsibility to manage Quality Design personnel, strategies, systems, initiatives, and financial resources for the GI Solutions Quality Design organization that is responsible for product development, product release, and quality initiatives
·Develop and maintain an effective/efficient Design system to assure compliance with applicable FDA and international laws/standards and Medtronic Corporate and Group policies
·Actively participate in Company, FDA, and Notified Body inspections including responding to observations, securing agreement of corrective actions, and participating in the implementation of corrective actions
·Provide quality design consultation and expertise to ensure the product requirements, documentation, and regulations are strictly adhered to
·Implement, develop and maintain department procedures and systems, with a focus on continual process improvement
·Participate in the GI Solutions strategic planning process in establishing quality and cross-functional goals for the business
·Develop annual budget including capital and operating budget proposals. Manage departments within approved budgets
·Maintain effective relationships and integrate activities with Medtronic Corporate, MITG, Regions, and other GI Solutions departments.
·Attract, hire, train, develop, motivate, review and manage talent to assure continuity of efficient Quality department operations
·Proactively investigate, identify, and implement best-in-class Quality Engineering practices
·Provide technical guidance and training in statistical analysis techniques to determine test sample sizes, protocol development, experimental design and other QA Engineering areas of expertise
·Assist in the development and/or write protocols and perform validations/verifications as necessary
·Manage the Quality Risk Management processes and requirements
·Support CAPAs as required. Establish effective corrective action plans and drives towards timely closure and effectiveness.
·Periodically draft, review and revise Quality System Procedures or other department operating procedures and assume accountability for all such procedures in the assigned areas
·Actively monitor post market surveillance data in assigned areas (i.e. complaints/MDRs), participate in complaint analysis as needed, and proactively administer technical investigation and corrective action programs to resolve recurring quality problems
·Participate in root cause analysis/failure investigations when necessary
·Support Standards Updates for adherence to latest versions of Product and Quality System Standards. Examples of such Standards include: IEC 606101, ISO 13485, ISO 14971 etc.
·Bachelor's degree in Biomedical, Mechanical, Software, or Chemical Engineering, or related field.
·Master’s degree in relevant field of study, preferred
·Seven or more year’s direct management experience in the medical device quality management function
·Hardware and Software QA design experience
·Solid knowledge and track recordin the application of Design Controls, Risk Management and Statistics towardssupporting new product development and sustenance of market released medical devices
· Strong knowledge of global regulations, demonstrated track record of effective management of regulatory agencies, and working knowledge of global product approval processes
· Demonstrated experience in compliance to QSR, GMP and ISO regulations
· Demonstrated desire and ability to lead continuous improvement programs and design/process reliability improvement initiatives
·Project managementexperience and demonstrated skills
· Internal and external audit experience, preferred
· Excellent track record in effective communication, planning and cross-functional collaboration
· Strong planning, partnering and organizational skills
· Strong data management and computer skills
·Knowledge of U.S., European and International regulations and standards covering medical devices.
· Experience with FDA and ISO audits, practical experience with ISO 13485, QSR, ISO9001.
·Excellent verbal and written English skills