Senior Quality Engineer

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.

Why Join Us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

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.

Become a maker of possible with us

Job Description Summary

The incumbent is responsible and accountable of establishing and coordinating all the validation activities for materials, products, equipment, processes and software. Maintaining the Validation Master Plan and training associates engaged in validation activities. Will also additionally support quality engineering/label control/assurance activities supporting operations.

You will lead the Risk Analysis/ PFMEA to identify needs for validation of manufacturing equipment/ process / software and support systems to meet product requirements, regulations, quality and company policies.

**Responsibilities**:

- Responsible for developing, implementing and maintaining the Risk Analysis / FMEA and Validation Master Plan for the Plant & supporting Quality Engineering activities including process monitoring, continuos improvements, metric reporting, data analysis, change control & control plans.
- Manages the Validation Tracking Schedule to ensure compliance with validation completion timelines and ensure its currency and accuracy.
- Performs and/or coordinate with Validation Practitioners the development of required validation protocols and the execution of the validation.
- Coordinates, supervises groups of Validation Practitioner, Contributors, Engineers and/or technicians on an ongoing validation activity for any projects.
- Prepares, reviews and approves the validation reports for completion, as well as close-outs of validations, following Validation Tool Kit practices.
- Responsible for providing support, training and assistance to on-site Validation Practitioners and contributors.
- Responsible for ensuring Validation Contractors compliance to BD Validation Policy and Procedures. Develop project scopes, schedules and budgets.
- Continuously evaluate information related to the overall performance of manufacturing process / equipment / software and any relevant support systems in addition to field complaints to activate re-validation activities when required.
- Create, revise or update validation procedures and policies as required. Prepare Change Notification documentation as required for procedures or processes as a result of validation requirements.
- Responsible for the quarantine the further processing of product in the event a non-conformance is detected during validation process.
- Work with US Site validation teams to sustain validation activities.
- Participate in Management Reviews and Executive Steering Committee to report on Validation Status as assigned.
- Assists in Internal QA Auditing Program, external regulatory and compliance audits/ inspections as required.
- Participates and contributes to continuous improvement activities. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements, brings regulatory compliance questions/ issues to the attention of management and/ or provide recommendations to improve effectiveness of validation work.- Leads cross functional teams for quality initiatives project for continuous improvements as per Quality tools such as Design of Experiments, Statistical/ Data Analysis, and MSA / Correlation.

Preferred Requirements
- Bachelor's Degree or equivalent in Microbiology, Biology Medical Technology with courses in Chemistry, Engineering or commensurate experience combined with specialized courses.
- 3 - 5 years experience in an industrial process/ equipment/ computerized system validations, risk analysis/ FMEA and/ or QA environment (such as Complaint handling, Change Control handling or Non-conforming handling) in medical devices, pharmaceutical or life science industry. Added advantage with working knowledge of current QSR's, ISO, and ANVISA standards.
- Experience in Statistics