This position supports managing the performance, development, implementation and maintenance of the Quality System within the North America Shared Service Center (NASSC) in order to meet applicable regulatory requirements (i.e. training, documentation, CAPA, quality metric analyses, etc.). This position is responsible for evaluating significant change(s) due to process transitions/absorptions to ensure compliance, escalates Quality issues to leadership, actively participates in Quality guidance, assists with resolution decisions and statistical problem-solving techniques for process improvement and continuous improvement activities. Serves as the Management Representative for the NASSC.
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.
Responsibilities
Consistent application of Quality system standards to NASSC by managing processes that support training of the regional complaint center, 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 Adverse Event and RCC 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.
Participate or lead CAPA Board, Management Review, and other Quality meetings
May perform other duties as required
Up to 10% travel
Hybrid work model
Minimum Requirement:
Minimum BA or BS degree in Science, Engineering, or other relevant discipline.
Preferred certification from ASQ in Quality Management, Quality Engineering, Quality Auditing, or Six Sigma Black/Green Belt
Minimum 5 yrs in medical industry.
Subject Matter Expert in Quality Systems for a service center. Experience working with the regulatory authorities (FDA, Health Canada, Notified Bodies, etc.), including participation in regulatory inspections and regulatory agency correspondence.
Knowledge and Skills:
Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485/14971, and SOR/98-282
Thorough understanding of problem identification, analysis, and conceptualization of business solutions
Strong knowledge of influencing, coaching, and people development principles
Experience in complaints management, recalls and customer escalated issues
Understanding of change management strategies and overcoming organizational roadblocks to achieve effective change
Expertise in conducting and participating in both internal and external audits
Ability to communicate effectively at all levels of the organization
Strong strategic thinking and leadership skills
Excellent problem solving and analytical skills
Supervises subordinates and/or experienced quality system specialist employees who exercise significant latitude and independence
Ability to empower individuals and teams to identify and overcome obstacles
Multi-site and remote management abilities
Ability to form and manage strong teams throughout the stages of team development
Excellent oral and written communication skills
Ability to assess competing priorities and multi-task
Continuous and versatile learner
Strong project management abilities
Use of computer based analytical, statistical, and modeling tools to identify and improve processes
Must be proficient in excel, and be able to quickly demonstrate proficiency in complaint handling systems
Strong interpersonal skills
Ability to influence without authority and deal effectively with ambiguity
Competence in writing and implementing training and training programs to diverse learning styles
#CLOLI
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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
