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.
The Quality Engineer I is accountable for supporting production or manufacturing activities through the application of Quality Engineering skills for medical devices. This person will understand, improve, and control operational processes to realize predictable product flow while satisfying established BD standards of quality. Successful performance requires close work with quality management, operations, and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Quality Engineering I Responsibilities: a minimum of 2 days support
Tracks, trends, and reports quality metrics such as nonconformances. This is achieved through effective analysis of quality data, provide recommendation to address adverse trend.
Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement projects.
Supports appropriate activities to address product nonconformances through Quality Notification (QN), Material Review Board (MRB), and CAPA process.
Initiates change control (ECR/O process).
Expected to assist in finding and documenting root cause(s).
Authors and revises procedures. Prepares reports, including quantitative / qualitative analysis, summaries, and protocols under guidance and support from technical project lead or management.
Support the change control process, such as the Assessment of Change Request or Change Event process.
Additional responsibilities maybe evaluated and/or added, based on business and Quality needs. Performs other tasks assigned by management as required.
QA Inspection Responsibilities - a minimum of 2 days support
Responsible for visual inspection of bottled products, components & kits. Review of manufacturing batch records to ensure completeness and accuracy. Review dilution, bottling & packaging processes to ensure all finished products meet specifications prior to releasing products to Finished Goods Inventory or Inventory Control for bottled components.
May provide technical guidance and training to others. Typically has team leader responsibilities. Proposes improvements to processes and may be responsible for quality execution of a process or analysis.
Participates in and contributes to continuous improvement initiatives. Works in collaboration with other functional departments in driving continuous improvement or implementing corrective action plans
Flexibility between two sets of responsibilities is needed to ensure timely product delivery to customers.
Education and Experience:
Bachelor’s Degree in Lifesciences discipline or Engineering
Minimum 1 year relevant experience or a combination of higher education and relevant experience.
Knowledge and Skills
Moderate knowledge of applicable regulatory requirements.
Knowledgeable with ISO 9001, ISO 13485, ISO 14971.
Root cause investigation and implementation of corrective / preventive actions
Proficiency in Minitab or other statistical software, MS Excel, and MS Word required. Proficiency in written and verbal communication skills.
Physical Demands: (if applicable)
Role is 70% use of laptop or desktop computer, hence sitting or standing.
Remaining 30% standing or walking
Potential travel between BDB San Diego buildings (8 miles apart).
Work Environment: (if applicable)
100% onsite or hybrid work model. Onsite is needed in case of business or quality support needed.
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.
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Required Skills
Optional Skills
Root Cause Investigations.
Primary Work LocationUSA CA - San Diego (BDB)Additional LocationsWork ShiftUS BD 1st Shift 8am-5pm (United States of America)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 or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$79,000.00 - $130,400.00 USD Annual