Senior Design Quality Systems Manager

About This Role

The Sr. Design Quality Systems Manager is responsible for ensuring compliance of the San Diego Design Center Quality System and consistent application of Design Control requirements and best practices. This role provides strategic direction for the Quality System architecture to support business needs and future growth.

Responsibilities

• Maintain and improve the IPD San Diego Design Center Quality System, providing strategic direction for its architecture
• Establish and maintain QMS linkages with all entities interacting with the IPD San Diego Design Center, and maintain 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 compliance of the San Diego Design Center QMS, maintain the internal audit program, coordinate external audits, and ensure readiness for external audits
• Ensure effective and consistent application of design controls across all programs, participate in Design Review meetings, and maintain a Design Controls training program
• Collaborate with core teams to establish Design Controls and Risk Management implementation strategies
• Responsible for the Risk Management system, ensuring consistent application and compliance with standards
• Establish and maintain linkages between Risk Management and other processes like Post Market Quality, Design Control, and Change Control
• Provide Quality functional support for labeling programs and process improvement activities
• Implement, Measure and Report on the progress of Quality Management Strategic initiatives
• Provide Quality functional support for implementation of electronic systems that impact the QMS

Requirements

• Bachelor's Degree in engineering or life sciences related field
• 10+ years progressive experience in Quality Assurance within an FDA regulated industry
• 3+ years of direct management experience of QA professional and technical staff
• Expertise in regulations affecting medical devices globally
• 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

Qualifications

• Bachelor's Degree in engineering or life sciences related field
• Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry, including QA administration and planning, with minimum 3 years of direct management experience of QA professional and technical staff

Nice to Have

• 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

Skills

* Required skills

Benefits