Job Description Summary

The Staff Quality Engineer reports to the Plant Quality Head, BD Biosciences (BDB) Business Milpitas Unit and is responsible for providing critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as design and process validation, measurement systems analysis, equipment and software validation. This role will be a Core Team member, or extended team member representing Site Quality on new product development and sustaining projects, will oversee the transfer of the new product and change to manufacturing. An individual in this position will work actively with the suppliers to transfer test methods and establish acceptance criteria for complex subassemblies. The position implements policies to ensure compliance with applicable US federal regulations, California state requirements, and global regulations.

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. 

Key Responsibilities for this Role: 

• Lead Facilities, Process, Test Method, Equipment, and Software Validations (IQ, OQ, PQ) for new product introduction and sustaining engineering projects

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

• Applies technical principles, theories, concepts, techniques and quality sciences / tools. Follows company procedures and makes procedural updates

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

• 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 Quality Assurance reviewer/approver or author for documentation such as protocols and reports, deviations, and design history files.

• 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 project

• Supports appropriate CAPA activities to accomplish internal/external objectives.

• Mentor associates in Quality system concepts and documentation.

Key Qualifications and Attributes:

• Staff QE should possess strong knowledge process validations and production and process controls

• An individual in this role must have excellent leadership, communication, organization and project management skills.

• The ability to make timely critical decisions regarding product quality and/or quality system compliance.

• An expert understanding of quality engineering sciences and their application to Validation activities

• A thorough understanding of 21 CFR §820, MDSAP, ISO 13485, ISO 9001 and ISO 14971.

• The ability to prepare, and understand technical documentation such as Engineering Drawings, Operating Procedures, Work Instructions, Technical/Validation Studies, etc.

• The ability to assess and articulate risk when evaluating a situation.

• The ability to perform thorough investigations, identify root cause(s) of an issue, and propose appropriate corrective action(s).

• The ability to communicate effectively in writing and orally, to organize work, and to achieve results when working alone or in teams.

Position Requirements

EDUCATION

• Typically requires a bachelor’s degree in science, engineering, or other relevant field and 5 years relevant experience or a combination of equivalent education and relevant experience.

LICENSES OR CERTIFICATIONS

• ASQ certification desired.

EXPERIENCE

• A minimum of 5 years of quality assurance or relevant experience. Experience should be in the Medical Device or Bioscience industry.

• Significant experience in Process validation, FDA regulations and ISO requirements.

SPECIAL SKILLS

• Good communication and presentation skills, Project Management, Trackwise systems, SAP.

• Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.

KNOWLEDGE OF SPECIFIC PROCEDURES/PRACTICES

• Knowledge of US and International regulations and standards that apply to the in vitro diagnostic and medical device industry, including FDA Quality Systems Regulations, MDSAP, ISO 13485 & 9001, ISO 14971,

• In-depth understanding of the application of QS to the medical device industry.

COMPLEXITY OF DUTIES

• Must be able to balance a complex agenda, ability to multitask.

• Must be well organized and methodical. Partners with cross-functional stakeholders to drive resolutions

• Works across BDX to share improvements and learn from others on areas for potential improvements.

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 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 CA - Milpitas 155

Additional Locations

Work Shift

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

$130,400.00 - $215,200.00 USD Annual