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. 

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Consistent application of Quality system standards to Department by managing processes that support training of the DCHU, customer impacting issues while prioritizing quality and compliance minded solutions that uphold the company and its standards

• Develop and mentor personnel, including dedicated succession planning and contingency management. Provide leadership directions/objectives, coach and develop associates.

• Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.

• Assist in the development and implementation of processes to improve the efficiency and effectivity of the MDR, DCHU (Internal and external) teams and continuously evaluate progress toward objectives adapting them to meet customer and business needs.

• Engage with (or may lead) quality networks as well as the business unit(s) and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision. Lead and support organizational change readiness to adopt process initiatives and reinforce the need for change so efforts are sustained long-term.

• Experienced Quality Leader with strong problem-solving skills, able to find innovative ways to resolve issues. Trained in Lean Six Sigma, TQM, or other problem-solving methodologies.

• Support and attend CAPA Board, Management Review, and other Quality meetings

• Oversight of Remediation Activities such as protocol, status reports, governance, and closing of CAPA activities.

• Oversight of Technology Solution to include; but not limited to, Trackwise, BOTS, AI, and etc.

Required Qualifications:

• BS/BA in engineering discipline or equivalent experience with Pyxis Dispensing experience leading a Quality Systems team.

• Minimum of 10 years of experience in Subject Matter Expert in Quality Systems role.

• Experience managing a team

• Experience in complaints management, recalls and customer escalated issues

• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 / 14971, and SOR/98-282 including participation in regulatory inspections and regulatory agency

• Specific knowledge of Pyxis Dispensing Units is preferred

• Preferred certification from ASQ in Quality Management, Quality Engineering, Quality Auditing, or Six Sigma Black/Green Belt

Knowledge and Skills:

• Experience in supervision; experience in managing a Quality System compliance team is a plus.

• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.

• Demonstrated ability to manage, develop and mentor exempt and non-exempt level personnel both inside and outside the department reporting structure.

• Thorough understanding of problem identification, analysis, and conceptualization of business solutions

• Strong knowledge of influencing, coaching, and people development principles

• Understanding of change management strategies and overcoming organizational roadblocks to achieve effective change

• Excellent computer skills (Including but not limited to: Microsoft Office, Minitab, SAP, TrackWise, SalesForce)

• Ability to communicate effectively at all levels of the organization

• Strong strategic thinking and leadership skills

• Multi-site and remote management abilities

• Ability to form and manage strong teams throughout the stages of team development

• Excellent oral and written communicati