Quality Engineer I
BD
Mebane, North Carolina
Full-Time
Competitive
RemoteExecutive
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.
Job Description Summary
The Quality Engineer I works as part of the Quality team at the Mebane Production Facility. The position will provide end-to-end support for all production lines; ensuring products are manufactured in compliance with internal procedures, quality standards, and applicable regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485). The Quality Engineer I assists with resolving production quality issues, performing nonconformance investigations, supporting root cause analysis, and driving corrective actions to maintain the integrity of the quality system.
Job Responsibilities:
Review and disposition nonconforming materials, components, and finished products under guidance from senior quality staff.
Conduct or support investigations into nonconformances, process deviations, and quality issues.
Assist in performing root cause analysis using tools such as 5 Whys, Fishbone diagrams, and other commonly used tools.
Support change control processes in accordance with internal procedures and regulatory standards, ensuring required risk management assessments are completed for changes
Evaluate Equipment Repair Forms to determine impact.
Participate in internal audits, process audits, and inspection readiness activities.
Support Corrective and Preventive Action (CAPA) activities as assigned.
Contribute to continuous improvement initiatives, including process capability studies and defect reduction efforts.
Review and update controlled documents, including work instructions, inspection procedures, and test methods.
Ensure operation is compliant to established procedures.
Maintain accurate data and monitor and report trends.
Analyze and summarize conclusions drawn from investigations and product analysis.
Perform tasks accurately and with great attention to detail.
Interface with manufacturing, engineering, product support and divisional groups.
Education & Experience
Bachelor's degree or equivalent experience in science, engineering, manufacturing technology or closely related field.
0-2 years of experience in a Quality / Regulatory / Operations / Engineering role in the medical device or similar industry (i.e.: FDA 21CFR820, ISO 13485, ISO 14791, etc.)
Knowledge & Skills Required
Basic knowledge of medical device regulations, risk management standards and application, manufacturing processes and root cause investigation methodologies.
Ability to work both independently and in partnership with others. Proven ability to use initiative and drive to achieve results.
Ability to interpret Corporate, Division and Department Procedures.
Ability to perform quality engineering work of a broad nature with little or no direction from Quality Management.
Must be able to comprehend and summarize data and document into reports.
Proficiency with Microsoft Office (Word, Excel, and PowerPoint).
Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
Ability to handle multiple task assignments and effectively manage time and priorities to meet deadlines.
Preferred Knowledge & Skills
Exposure to Continuous Improvement tools and methodologies.
Knowledge of validation, equipment calibration and change management.
Ability to use Microsoft Excel and/or Minitab to perform trend analysis.
Prior experience with SAP.
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.
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under “Our Commitment to You”. Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.
Salary: $ 75,800.00 - 121,300.00 USD Annual plus incentives.
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 visithttps://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.
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