Job Description Summary

The Senior Quality Manager, Quality Instruments serves as Plant Quality leader for the BD IDS Instrument plant and has responsibility for applying/interpreting the applicable Quality Systems and developing/implementing the Standard Operating Procedures for that site. Through outstanding communication, effective problem solving and active management of ambiguous situations the Senior Quality Manager ensures: product safety, product quality and compliance with all relevant global regulations and customer expectations. Provides interpretation of companywide policies and procedures and ensures their appropriate implementation. Develops and maintains budgets, schedules and performance requirements. Mentor and develop personal including identification and development of high potential associates within the quality organization. Responsibilities include understanding the key drivers in the organization to set and execute operational objectives with the leadership team. Develops strategies that support the business and the Quality organization. Responsible for assuring departmental compliance with ISO and FDA requirements through supporting supplier audit program, delegating participation on product enhancement teams, supporting a robust CAPA program, and ensuring that all aspects of the Quality Management System have the appropriate Quality oversight and maintenance to ensure a continuous state of compliance.

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. 

Job Responsibilities

• Functions as the Management Representative for the Instrument plant quality management system

• Responsible for the Quality Engineering, Quality Control, and Finished product release Department including the evaluation of Quality Control results and the decision to release products. Ensures that the quality system is established and maintained efficiently, reports the quality system performance to management for review and promotes awareness of regulatory and customer requirements throughout the organization.

• Responsible for developing, managing, maintaining, reporting, and improving plant quality metrics which includes Plant/Site Management Review for IDS Instruments. Evaluate metrics to determine if quality problems exist and set the appropriate action and escalation

• Decisions have an extended impact on work processes and outcomes. Erroneous decisions result in critical delays and modification to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business performance

• Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.

• Implements strategic policies when selecting methods and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans and performance requirements. This position is accountable for responsibilities with high complexity. Has in-depth understanding of quality and regulatory principles.

• Establishes operating policies and procedures that affect business unit as well as local departments.

• Contributes to the development of strategies.

• Interprets company-wide policies and procedures. Develops budgets, schedules and performance standards.

• Regularly interacts with senior management or executive levels on matters concerning cross-functional areas and/or external customers.

• Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.

• Often serves on Leadership Teams such as Business Line (BL), Plant LT (Leadership Team), Extended Quality LT at the JG5+ level (EQLT)

• Establishes operational objectives and work plans; delegates assignments to associates.

• Manages subordinate managers and/or experienced specialist employees who exercise significant latitude and independence

• Advances the Leadership Bench strength of the compan