Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryThis role’s primary responsibility is to work cross functionally in the development, assessment, qualification and improvement of Distribution processes in accordance with all regulatory requirements and company procedures. The Quality Engineer role reports to the Manager, Quality, US Distribution Management.
- Responsible for Quality processes as assigned including, but not limited to Change Control, CAPA, CI, Risk Management and Validation.
- Applies analytical methods and statistical techniques in evaluating process and service provider performance.
- Works within and across functions for process development, maintenance, improvement and issue resolution. Develops solutions to routine assigned activities of moderate scope & complexity.
- Consistent application of Quality System standards to Quality processes.
- Serves as a Designated Representative as appropriate to ensure day to day operations meet states’ licensing requirements for medical device and/or wholesale drug distribution regulations as applicable.
- Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business.
- Employ and share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues.
- Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements.
- Follows applicable Company / Unit procedures and may make updates to procedures and policies.
- Represents local site during regional process meetings, communicates resolutions to issues to prevent occurrences at other sites and assess learning/best practices from other sites for applicability to local site.
- Partner and effectively collaborate across functions and sites to address and/or improve Distribution performance as the Subject Matter Expert (SME), trainer and owner of the following Quality Systems:
- Change Control, including leadership of the local Change Control Board, and associated records.
- CAPA, including leadership of the local CAPA Council and site representation on the Regional CAPA Council, Trackwise for CAPA and process metrics.
- Validations and Qualifications, including the protocol development, execution and records.
- Risk Assessment, as applicable to the above in addition to maintenance of the local Risk Management File.
- Analysis of Data, through analytical methods and statistical techniques that support and/or measure performance, investigations, sample planning, improvements, corrective actions, preventive actions, implementations and effectiveness.
- Environmental Monitoring
- Monitor for trends, escalations, and partner with sources of root causes to implement effective corrective actions that reduce non-conformances and risk in future shipments.
- Partner with Operations and Supply Chain Relations on customer related issues and driving claims to resolution where escalation is needed.
- Generate monthly and quarterly metric reports for regional leadership review. Attend and participate in Regional DC Quality metric calls. Represent Quality as a member of the local DC leadership team.
- Attend weekly and/or monthly site manager/process owner meetings as established.
- Conduct audits as required in compliance with regulatory requirements, e.g. ISO 13485, 21 CFR 820.
- Travel to support Quality Management and audit functions at other DC facilities, and support Customer visits to gain an understanding of Customer issues, determine root cause, establish and drive corrective actions and improve Customer satisfaction.
- Other duties as assigned.
- Minimum of 8 years’ experience within quality, supply chain, manufacturing and/or distribution
- Minimum of 3 years’ Quality experience in a regulated environment, preferably in Medical Device and/or Pharmaceutical.
- Computer skills (Excel, Word, Power Point, etc.)
Process oriented, Continuous Improvement Experience
- People leadership including developing, coaching, listening, collaborating, and delegating
- Organizational, analytical and process efficiency skills
- Interpersonal and communication skills (written and oral)
- Project leadership skills
- Initiative and drive for results
- Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820, preferred
- BS Degree in Quality Engineering preferred, or related discipline.
ISO 13485 and 21 CFR 820 Lead Auditor certified preferred
- CQE, Green and/or Black belt certification/s preferred, but not required.
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.
Primary Work LocationUSA NC - Four Oaks
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
Senior Director Quality Management
To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
Manager Medical Laboratory