JOB DESCRIPTION SUMMARY

Sr Design Quality Systems Manager reports to the Director, Quality Management, WWIPD. The Sr Design Quality Systems Manager is responsible for the San Diego Design Center Quality Systems, Compliance, and for ensuring consistent application of Design Controls requirements and best practices.

REQUIRED QUALIFICATIONS:

• 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.

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.

KNOWLEDGE AND SKILLS:

• Quality Management Systems requirements for medical devices
• Knowledge and applied experience of 21CFR, MDD 93/42/EEC, MDR 2017/745, ISO13485, and ISO14971
• Quality system auditing
• Management of FDA and notified body audits.
• Risk Management
• Change control.
• Software Validation
• Test method validations
• Post Market Surveillance
• Statistical Analysis
• CAPA – Root cause investigation and implementation of corrective/ preventive actions
• Excellent oral and written communication skills, assertiveness skills
• Good written and oral communication
• Cross functional team collaboration and influencing.
• Critical thinking and analytical skills
  At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
  For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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.

SCOPE OF RESPONSIBILITIES

• Leads a team of specialist that support the Quality Management System, including the CAPA and internal audit processes.
• Assignments are often self-initiated. Determine and pursue course of action necessary to obtain desired results.
• Participates in, and may provide leadership for multi-disciplinary projects
• Considered Site Quality Management System Subject Matter Expert, including Design Controls and Risk Management.