Quality Assurance Manager

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 Med Tech 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…