Job Description Summary

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 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 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. 

The Quality Assurance Manager has the responsibility of managing and developing the QA Team in Irvine, CA. The individual provides Quality Engineering/Systems leadership to support Operations and to drive continuous improvement while ensuring compliance to procedures and requirements. The daily tasks associated with the role are incoming quality control, manufacturing, materials management, labeling, and product disposition management along with maintenance of the quality system.

Essential duties and responsibilities:

• Manages QA department and overall expectations pertaining to setting accurate schedules, costs and resources.

• Ensures department is adequately resourced and trained to perform jobs effectively.

• Directly supervises QA staff including mentoring and developing to enable maximum performance and individual employee growth, providing regular performance review and feedback and using corrective action as necessary.

• Ensures delivery against QA department goals and objectives, i.e. meeting commitments and coordinating overall quality assurance schedule.

• Encourages a team environment, leads by example and demonstrates servant leadership skills.

• Prepares and maintains department budgets.

• Serves as a team member to provide quality engineering expertise to continuous improvement teams and manufacturing support.

• Implements ongoing quality improvement processes working with interdepartmental teams.

• Develops project schedules and resource allocation models for QA related projects and other activities to support project teams.

• Provides effective communication regarding issues, objectives, initiatives and performance to plan.

• Develops inspection and process control procedures, processes through document control and provides training for the procedures.

• Develops metrics to identify and prioritize activities pertinent to process control, risk reduction, and cost improvement.

• Manages non-conformance data and provides oversight for corrections, trending, tracking, external communications, closure and reporting.

• Develops, tracks, trends, reports and maintains Quality Indicators to enhance quality of products and business performance.

• Facilitates communication and teamwork between R&D/NPD and Operations, towards the purpose of design transfer.

• Ensures conformance to change control requirements for process and production changes.

• Maintains compliance to FDA Quality System Regulations, ISO:13485 standards and other regulations, as applicable.

• Performs special assignments and other duties as assigned.

• Interfaces effectively with senior leadership.

• Supports internal and external audits/inspections.

• Prepares and implements facility policies and procedures relating to quality.

• Ensures alignment and compliance to Corporate, Segment, Business Unit, and Department procedures.

Qualifications:

• Verbal communication skills and presentation skills: Ability to create and understands how to present information dependent upon the level of the audience.

• Technical writing skills: Creating reports, presentations, rework protocols, validation protocols, metrics, procedures, forms, flowcharts, quality plans, quality agreements, etc., and review and approve technical documentation, as required.

• Leadership skills: Prioritizing resources based on changing business needs.

• Budgeting skills: Ability to control costs while providing appropriate resources in order to maintain compliance posture while meeting business needs.

• Computer skills: Ability to create and manage technical documents, as needed; ability to use electronic communication, time management, ERP and EDMS systems.

• Knowledge of medical device regulation, industry or international standards. Ability to understand Organization, Corporate, Business Unit, and other Facilities Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.

• Knowledge and demonstrated use of document control, training and time management practices and investigational techniques (e.g., CAPA, non-conformance, thresholds, fishbone, 5-Whys).

• Ability to interpret Regulations and Procedures.

• Extensive knowledge of quality systems and relationship to business, along with inspection, testing, product release, manufacturing processes and associated systems.

• Fundamental knowledge of validation principles.

• Understands basic applied statistics, statistical sampling plans, and statistical process control..

• Ability to find opportunities for quality and cost improvements.

• Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understand team functions, leadership techniques and project management methodologies.

• Ability to effectively manage time and handle multiple task assignments.

• Ability to translate quality requirements into product specifications.

EDUCATION and/or EXPERIENCE:

• Bachelor’s degree or higher in Science, Engineering, Technology or related field.

• Minimum of seven (7) years’ experience in quality engineering within medical device or pharmaceutical manufacturing.

• Two (2) plus years' supervisory experience.

• Class III medical device experience is required.

• Working knowledge of chemical and molecular processes.

• Experience with managing FDA audits.

• Thorough knowledge of regulations governing production, packaging, inspection (preferably incoming/final release), testing and warehousing.

• ASQ CQE certification preferred.

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.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

#LI-PRO

Required Skills

Optional Skills

.

Primary Work Location

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information