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.

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…