Job Description Summary

Job Description

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. 

Job Summary:

The Staff Quality Engineer is accountable as Quality Assurance representative to support reagent new product development and/or product and process sustaining activities through the application of Quality engineering skills for medical devices. Products include, but are not limited to IVD liquid and dried antibody.

For New Product Development activities, this person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.  This role will support the clinical IVD design and development.

For Sustaining Product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established regulatory and BD standards of quality.  Activities include working independently or with a team to perform process validation, risk assessment and management, design control, CAPA, and supplier management.  Successful performance requires close work with quality management, operations, R&D, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.

Job Responsibilities:

• Supports quality activities for the development, implementation, and ongoing support of IVD reagent products and their related processes, equipment, and software.

• Is a Core Team member, or extended team member representing Site Quality on new product development projects and a team member for sustaining engineering projects.

• Acts as project lead for process improvement projects such as Shingi or Kaizen or projects as defined during annual Quality Objectives development.

• Guides the successful completion of major programs and may function in a project leadership role.

• Act as QA lead for facility design, validation controlled non-classified (CNC) manufacturing area Mentor, coach, and guide junior QE team members to enable development of self and others.

• Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations.

• Implements and communicates the strategic and technical direction for the product/project team Identifies any issues that may delay product or project and recommends appropriate action to be taken. 

• Independently determine options to address issues ensuring quality, and business continuity.

• Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.

• Demonstrates working knowledge of applicable regulatory, corporate and/or Unit requirements.

• Provides audit support (preparation, closure, etc. activities). 

• Acts as site’s validation expert or subject matter expert for validation and be able to communicate with external and internal auditors.

• Revises policies/procedures. 

• Prepares reports, including quantitative / qualitative analysis, summaries, and protocols.

• Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, and 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.

• Additional responsibilities maybe evaluated and or added, based on business and quality needs. 

• Performs other tasks assigned by management as required.  

Education and Experience:

• Requires a minimum of a Bachelor’s Degree in biological science or engineering.

• A minimum of 10 years relevant experience in equipment validation, process validation, and cleanroom facility design and validation.  

• ASQ Certified Quality Engineer or equivalent (preferred)

Knowledge and Skills:

Knowledge

• Extensive knowledge of applicable regulatory requirements.

• Working knowledge and experience with the application of ISO 9001, ISO 13485, ISO 14971, ISO14644 series, ISO 14698 series.

• Process, Test Method, Equipment, and Software Validations (IQ, OQ, PQ)

• Design Control (Both New Product Development and Sustaining Processes as applicable)         

• Risk Management

• Facility design, cleanroom validation, critical system validation

Skills

• An expert in statistics. 

• Class II / III medical device experience (preferred). 

• Knowledge of design control principles (preferred). 

• Ability to provide support to internal / external audits.

• 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

Work Environment:

• 100% onsite work model. 

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.

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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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.

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