Sr Design Quality Systems Manager

Becton Dickinson Medical Devices•Brea, CA

12d•Onsite

About The Position

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. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is o ur Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

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.

Nice To Haves

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.
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

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.
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.