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Sr. Design Quality Systems Manager
Becton Dickinson
- San Diego, California, United States
- San Diego, California, United States
Über
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 21CFR, MDD 93/42/EEC, MDR 2017/745, ISO13485. 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, Building A & B. Additional locations: USA, CA – Brea. Work shift:
At least 4 days of in‑office presence per week. Remote or field‑based positions have different workplace arrangements indicated in the job posting. COVID‑19 vaccination requirement: employment is contingent on proof that you are fully vaccinated against COVID‑19 where required. Compensation
Salary Range: $158,300.00 – $261,100.00 USD per year. More Information
For more information, visit https://bd.com/careers. Equal Opportunity Employer
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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Sprachkenntnisse
- English
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