Sr Design Quality Systems Manager
Company | Becton Dickinson |
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Location | Brea, CA, USA, San Diego, CA, USA |
Salary | $Not Provided – $Not Provided |
Type | Full-Time |
Degrees | Bachelor’s |
Experience Level | Senior, Expert or higher |
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.