Sr. Quality Engineer

Senior Quality Engineer

The Senior Quality Engineer ensures compliance with Quality System, ISO, and FDA requirements by developing and implementing SOPs, quality policies, and process controls across the Media and IDAST plants. This role partners cross-functionally to drive consistent manufacturing practices, support audits, lead quality improvement initiatives, manage CAPAs, and ensure successful product launches. Using data analysis and quality tools such as SPC, statistical sampling, Six Sigma, and root cause analysis, the engineer identifies opportunities for continuous improvement and resolves quality issues effectively.

Responsibilities:

• Monitor, analyze, and trend quality indicators for purchased materials, as well as manufactured and distributed components and products, to drive product quality and performance improvements.
• Evaluate Critical to Quality (CTQ) parameters and risk assessment variables to support informed decision-making, predictable product design, and efficient product flow.
• Serve as a key Quality Management (QM) Engineering resource, supporting both Media QM Engineering initiatives and day-to-day quality engineering activities for assigned products and operational areas.
• Partner closely with the Plant Senior Quality Manager to ensure the consistent implementation and application of Quality Systems across new and existing product lines, as well as Enterprise business systems.
• Support compliance with ISO, FDA, and internal quality requirements through: Internal and external audit participation, Cross-functional team collaboration, Project support and execution, Product launches and transfers, Process improvement initiatives, CAPA coordination and resolution, Product quality notifications, Change notifications, Customer complaint investigations and follow-up
• Utilize root cause analysis methodologies and quality tools to identify issues, drive investigations, and implement effective corrective and preventive actions.
• Develop, execute, and monitor corrective action plans to address quality concerns and drive sustainable improvements.
• Leverage Enterprise tools and systems to ensure regulatory compliance, improve visibility, and streamline quality processes.
• Collaborate across functions to promote continuous improvement, strengthen quality system effectiveness, and support operational excellence.

• Demonstrate the ability to proactively manage multiple priorities, lead key initiatives, and drive the successful execution of organizational change efforts.
• Lead and support process control, supplier quality, and continuous improvement projects focused on enhancing product quality, operational efficiency, and compliance.
• Apply statistical methods and quality tools, including statistical sampling and Statistical Process Control (SPC), to analyze performance, identify trends, and implement data-driven improvements.
• Collaborate with cross-functional teams to identify opportunities for process optimization, problem-solving, and sustainable quality improvements.

Required Qualifications:

• Bachelor's degree in sciences or other relevant technical field
• 3 years' experience in Quality Engineering or other related field.
• Experience in a medical device, pharmaceutical manufacturing facility, or other relevant manufacturing field.

Knowledge and Skills:

• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Preferred and additional skills and qualifications
• Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485 and 14971.
• Minitab experience is a plus.
• Familiarity with Six sigma, Lean Tools, root cause analysis, and project management techniques
• Ability to represent functional and operations organization with transparency and lead conflict resolution in wide variety of settings.
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.

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 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

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Primary Work Location: USA MD - Hunt Valley

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$95,900.00 - $153,400.00 USD Annual