Overview
Sr. Design Quality Systems Manager Jobs in San Diego, USA at Becton Dickinson
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our 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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
Reports to the Director, Quality Engineering, WWIPD. The Sr Design Quality Systems Manager is responsible for the San Diego Design Center Quality System Compliance, ensuring consistent application of Design Control requirements and best practices.
Responsibilities
- Maintain and improve the IPD San Diego Design Center Quality System; provide strategic direction so that the QS architecture supports business needs and future growth.
- Establish and maintain QMS linkages with all entities that interact 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 for Management Review meetings.
- Maintain effectiveness of the CAPA process and the internal audit program; coordinate external audits and ensure design center sites are ready for them.
- Ensure effective and consistent application of design controls across all programs in scope of San Diego Design Center; participate in Design Review meetings and establish a Design Controls training program.
- Collaborate with core teams to establish Design Controls and Risk Management implementation strategies in compliance with internal, industry, and government standards.
- Responsible for the Risk Management system, ensuring its consistent application and compliance with internal, industry, and government standards.
- Establish and maintain linkages between Risk Management and other processes such as Post Market Quality, Design Control, and Change Control.
- 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.
- Provide software validation quality functional support for implementation of electronic systems that impact the QMS.
- Lead a team of specialists supporting the QMS, including CAPA and internal audit processes.
- Determine and pursue course of action necessary to obtain desired results and may provide leadership for multi‑disciplinary projects.
Required Qualifications
- Bachelor’s Degree in engineering or life sciences related field.
- Minimum ten (10) years progressive experience maintaining a Quality System within an FDA regulated industry; QMS administration and planning experience required.
- Minimum three (3) years of direct management experience of QA professionals and technical staff.
- Expertise in regulations affecting medical devices marketed worldwide.
- Expertise in failure investigation and medical device CAPA process.
- Experience in medical device product development and application of Design Controls in a Design Center.
- Proven understanding of design quality assurance.
- 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).
- Lead Quality System Auditor experience.
- Green Belt or Black Belt from a recognized program.
Knowledge and Skills
- Knowledge of Quality Management Systems requirements for medical devices.
- Applied experience of 21
CFR, MDD 93/42/EEC, MDR 2017/745, ISO
13485. - Quality system auditing and notified body audit management.
- Risk Management and change control.
- Test method validations, CAPA – root cause investigation and implementation of corrective/preventive actions.
- Excellent oral and written communication skills, assertiveness.
- Cross‑functional team collaboration and influencing.
- Critical thinking and analytical skills.
Location and Work Requirements
- Primary work location: USA, CA – San Diego,…
Title: Sr. Design Quality Systems Manager
Company: Becton Dickinson
Location: San Diego, USA
Category:
