We are the people who give possibilities purpose
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.
The Sr. Quality Engineer is responsible for supporting Product Lifecycle Management and Design Quality Assurance within the Infection Prevention Platform. The incumbent works multi-functionally with teams on change management projects (including those that may impact product design), design transfers, global expansion projects, risk management, process/product design and development, quality improvement projects (QIPs), and cost to win (CTW) projects.
General Functions, Specific Responsibilities, and Authority
The Sr. Quality Engineer works closely with shared functions (e.g. Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, etc.), as well as R&D, Manufacturing, Sales, Marketing, Operations, Supply Chain, and Finance.
The Sr. Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply to product change regulatory submissions and regional expansions, with DCHU on complaint handling/resolution and field actions pre-/post - product launch, Packaging COE on new product packaging projects and changes, Sterility Assurance on sterilization process (re)validations and with Platform Management regarding product design and development, as well as design transfer activities.
Product Quality and Lifecycle Management:
Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
Lead Quality Engineering Projects to improve Quality systems and Procedures.
Support or leads change management activities including risk and design impact assessments.
Update and maintain product Design History File (DHF) & Drug Master File (DMF) based on change activities.
Development and maintenance of the Risk Management File in accordance with ISO14971, coordinating input from the other Design Sub-team members including the development of the design, process, and usability FMEAs.
Develop or assist in development and qualification of inspection and test methods and equipment.
Develop and document the Control Plan / System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.
Support the development of manufacturing control plans for internal and outsourced processes.
Support (or lead) development of the PFMEA, Process Requirements Specifications (PRS), and Validation Plans and Protocols including developing statistical sampling requirements.
Perform and/or Support Process Development Studies to determine the acceptability of new processes or equipment.
Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, CMC, and ISO13485 requirements.
Lead supplier part qualification activities including mold qualification and DOEs (PPAP).
Support Design / Process Transfers to the Production facilities as well as line expansion / capacity / productivity changes.
Other:
Supports new global expansion efforts for existing products.
Liaison between OUS quality and plant quality.
Support the disposition investigation and decisions of rejected nonconforming components and products; conduct MRB action when required.
Organize and generate detailed quality information reports to show trends and the impact of process improvements.
Conduct other Quality Control Projects as assigned by the Manager of Quality Engineering.
Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.
Perform DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required.
Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.
Support goals of the Quality Assurance / Engineering Department.
Mentor junior QE staff
Knowledge, Education, and Skills Required
Bachelor's degree in Engineering from an accredited four (4) year university.
5 - 8 years Quality Engineering experience with pharmaceutical, combination products, or medical devices.
Pharmaceutical or combination product experience, preferred.
ASQ Certified Quality Engineer (CQE), Six Sigma Black Belt (SSBB), or advanced degree preferred.
Experience operating in GLP, GMP, and GDP.
Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred.
Experience with ERP systems and software such as SAP, preferred.
Attentiveness to details with strong organizational skills.
Ability to work proactively and independently.
Ability to multi-task and efficient in time management.
Excellent verbal communication and interpersonal skills.
Ability to work in a team environment.
Proficiency in Excel, Word, and other desktop/general business systems
Approximately 15 - 20% travel may be required.
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
Required Skills
Optional Skills
USA TX - El Paso - Northwestern Dr.
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. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
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