Job Description Summary

As the Quality Engineer/Validation Specialist, you will be monitoring all the operational aspects of the quality system and where appropriate, using relevant quality tools to support business activities to improve the operational effectiveness of the quality system. You will also be responsible for providing validation guidance and training for all validation practitioners ensuring compliance to relevant procedures.

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!

If you are looking to be part of a team that manufactures millions of lifesaving medical devices throughout the world each year and if you thrive in a highly technical fast paced manufacturing environment, then Push Button at BD is the ultimate place to work. With state-of-the-art technology, which includes packaging robots, quality assurance vision inspection systems, ultraviolet curing, precision liquid dispensing, Allen Bradley PLC and HMI technology, all within a highly integrated automated assembly unit, Push Button is one of the Southwest’s most technically advanced manufacturing lines and we are looking for talented individuals to ensure that our world class product continues to advance the world of health.

Main responsibilities will include:

• Use six sigma continuous improvement techniques to implement suitable corrective and preventive actions to reduce quality issues.

• Communicate with and co-ordinate the activities of the relevant departments to ensure compliance with documented specifications and procedures within the quality system.

• Support both operations and engineering departments in cross-functional teams.

• Develop and issue control plans, quality documentation and visual aids.

• Provide training and development for SPC on production processes.

• Support cross-functional activities in the execution of Validations.

• Provide quality engineering support for internal audits, third party regulatory audits and customer complaints as required.

• Provide statistical advice for process investigation.

• Actively support and lead the development and maintenance of BD’s quality systems (SAP / SFOL / QDMS).

• Ensure the detail and content of Quality Notifications / MRB decisions conform to the relevant procedural documentation.

• Audit / authorise release of the Document History Records for each production batch.

• Develop the Validation Master Plan (VMP) to ensure ongoing improvements to validation effectiveness.

• Provide effective training for all validation practitioners to ensure compliance with the validation toolkit and related procedures.

• Review and approve all validation protocols and completion reports to ensure compliance.

• Represent Plymouth on cross plant validation discussions as required to ensure common practice.

• Support the Regulatory Library Administrator in the control and storage of validation reports and associated documentation.

• Develop and produce validation process metrics in compliance with documented procedures or as requested.

About you:

• Degree / HND / CQI Diploma level in a Science or Engineering discipline is essential.

• Proven experience in a quality role within a high volume medical device-manufacturing controlled environment is a distinct advantage.

• Proficiency with MS Office, Minitab, or similar statistical analysis tools.

• Be a certified Process Validation Practitioner and/or Instructor.

• Knowledge of Six Sigma and Lean Manufacturing principles.

• Excellent written and verbal communication skills.

• Ability to work effectively as part of a team and manage multiple priorities simultaneously.

Click on apply if this sounds like you!

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.

To learn more about BD visit: https://bd.com/careers

Required Skills

Optional Skills

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Primary Work Location

GBR Plymouth - Belliver Industrial Estate

Additional Locations

Work Shift

GB-PLY Office Staff 0800-1600 37.5 (United Kingdom)