Quality Engineer II
Job Description Summary
Quality Engineer II will assist the Manufacturing Department in the establishment and implementation of programs designed to assure control of processes and products toward established quality standards. Use problem solving techniques to improve quality within the business. The incumbent will be capable of self-direction and project management to ensure successful outcomes. Successful performance requires close work with quality management, operations, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.
Job Description
We are the makers of possible
As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters.
Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.
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Responsibilities:
- Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
- Work with Manufacturing operations to implement plant driven changes and provide overall support of process improvements by working with engineering teams to implement process improvements to improve Quality, conducting quality improvement projects through various CI initiatives.
- Develop or update in-process inspection requirements to ensure the greatest value in process control for the customer and the plant during the manufacturing process while meeting regulatory requirements
- Provide assistance in such areas as process/equipment validation, process and product acceptance, audit correction actions, Change Control issuance for process changes.
- Manages completion of assigned complaint investigation files and works with the manufacturing site or suppliers where necessary, to complete the investigation within a timely fashion.
- Support CAPAs as owner or as part of the support team
- Monitor quality data from complaints process, Manufacturing reports, Service reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Service, Engineering, Regulatory and Biostatics.
- Work to implement document changes in support of ongoing efforts to simplify internal quality procedures in alignment with business unit and corporate requirements.
- Leading investigations for quality issues resulting in yield issues by using applicable problem solving and root cause techniques.
- Complete training to support Manufacturing Quality for day-to-day operations including assuring product release, manufacturing quality training and Material Review Board (MRB) activities.
- Lead or participate in Risk Management activities appropriate to the initiative or situation.
- Lead situation analysis and support activities relating to Field Corrective Actions, when needed.
- Work collaboratively and cross functionally to improve product performance. Utilize trouble shooting and problem solving skills to identify and eliminate issues that negatively impact product performance
Qualifications:
- Bachelor's degree in Engineering or Science is required.
- A minimum of 3 years of experience Quality manufacturing experience
- A minimum of 3 years of experience working in an FDA or ISO regulated environment/GMP/Medical device manufacturing.
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
$84,300.00 - $138,900.00 USD Annual
Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion