Sr Design Quality Systems Manager

Sr Design Quality Systems Manager

Requirements

• Bachelor’s Degree required in engineering or life sciences related field.
• Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry; QA administration and planning experience required.
• Minimum 3 (three) years of direct management experience of QA professional and technical staff
• Expertise in regulations affecting medical devices marketed in all regions throughout the world.
• Expertise in failure investigation and medical device CAPA process.
• Experience in medical device product development and application of Design Controls.
• Strong understanding of design quality assurance.
• Lead Quality System auditor experience.
• Experience managing regulatory audits and responding to regulatory authorities.
• Proven leadership capability and teamwork across functions and regions.
• Ability to manage complex situations and make sound decisions.

Responsibilities

• Maintain and improve the IPD San Diego Design Center Quality System, provide strategic direction so that the QS architecture support the business needs and future growth.
• Establish and maintain QMS linkages with all entities that interact with the IPD San Diego Design Center. Maintains quality agreements.
• Monitor the effectiveness of the QMS, review key indicators, address negative trends, and prepare Management Review meetings.
• Maintain effectiveness of the CAPA process.
• Ensure effective and consistent application of design controls across all programs in scope of San Diego Design Center.
• Collaborates with core teams to establish Design Controls and Risk Management implementation strategies in compliance with internal, Industry, and Government Standards.
• Participates in Design Review meetings.
• Establish and maintain a Design Controls training program.
• Responsible for Risk Management system. Ensures consistent application of risk management, its effectiveness, and for maintaining compliance with internal, Industry, and Government Standards.
• Responsible for establishing and maintaining linkages between Risk Management and other processes such as Post Market Quality, Design Control, and Change Control.
• Ensure compliance of the San Diego Design Center QMS.
• Maintain effectiveness of the internal audit program.
• Coordinates external audits and ensures that Design center sites are ready to manage external audits.
• Provide Quality functional support for labeling programs and labeling process improvement activities.
• Implement, Measure and Report on the progress of the Quality Management Strategic initiatives, such as Inspire Quality.
• Software validation
• Quality functional support for implementation of electronic systems that that impact the QMS.

Preferred Qualifications

• Certified as Engineer or Auditor by the American Society for Quality (ASQ).
• Green Belt or Black Belt from a recognized program.
• Experience working in a design center.