Quality Engineer/Validation Specialist

BD; Plymouth; On-site; GBP 40,000 - 65,000; Full time

Job summary

An established industry player seeks a Quality Engineer/Validation Specialist to enhance operational effectiveness in a fast-paced medical device manufacturing environment. This role involves utilizing Six Sigma techniques, developing quality documentation, and ensuring compliance with validation protocols. Join a dynamic team dedicated to advancing health worldwide, where your contributions will directly impact the production of lifesaving medical devices. If you are passionate about quality assurance and thrive in a collaborative setting, this opportunity is perfect for you.

Qualifications

• Degree or equivalent in Science or Engineering required.
• Experience in high-volume medical device manufacturing is advantageous.

Responsibilities

• Implement corrective actions using Six Sigma techniques to improve quality.
• Train staff on Statistical Process Control and validation procedures.

Skills

Six Sigma

Statistical Process Control (SPC)

Communication Skills

Lean Principles

Education

Degree in Science or Engineering

Tools

Minitab

SAP

SFOL

QDMS

Job description

Job Description Summary

As the Quality Engineer/Validation Specialist, you will monitor all operational aspects of the quality system and utilize relevant quality tools to support business activities, aiming to improve operational effectiveness. You will also provide validation guidance and training for validation practitioners, ensuring compliance with relevant procedures.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies. Our purpose is advancing health worldwide. Achieving this involves the imagination and passion of our teams—covering design, engineering, manufacturing, and marketing—to turn the impossible into transformative solutions.

Why join us?

A career at BD offers the opportunity to work alongside inspiring leaders and colleagues in an inclusive, growth-oriented culture. You can help shape BD’s future and leave a legacy. We seek individuals with the imagination and drive to reinvent health’s future. At BD, you will learn, grow, thrive, and contribute to making the world a better place.

Join us as a maker of possible!

If you thrive in a fast-paced, highly technical manufacturing environment and are involved in producing millions of lifesaving medical devices annually, BD’s advanced technology and automated manufacturing lines provide an ideal setting for your talents.

Main Responsibilities

1. Use Six Sigma techniques to implement corrective and preventive actions to reduce quality issues.
2. Coordinate with relevant departments to ensure compliance with specifications and procedures within the quality system.
3. Support operations and engineering teams in cross-functional activities.
4. Develop and issue control plans, quality documentation, and visual aids.
5. Train staff on Statistical Process Control (SPC) and related processes.
6. Support validation activities and ensure compliance of validation protocols and reports.
7. Provide support for internal audits, regulatory audits, and customer complaints.
8. Offer statistical advice for process investigations.
9. Maintain BD’s quality systems (SAP, SFOL, QDMS).
10. Ensure quality notifications and MRB decisions meet procedural standards.
11. Audit and authorize release of production batch records.
12. Develop and improve the Validation Master Plan.
13. Train validation practitioners on validation procedures and tools.
14. Review and approve validation documentation.
15. Represent Plymouth in cross-plant validation discussions.
16. Support validation report control and storage.
17. Develop validation process metrics as per procedures.

About You

1. Degree or equivalent in Science or Engineering.
2. Experience in a high-volume medical device manufacturing environment is advantageous.
3. Proficiency with MS Office and statistical tools like Minitab.
4. Certified Process Validation Practitioner and/or Instructor preferred.
5. Knowledge of Six Sigma and Lean principles.
6. Excellent communication skills.
7. Ability to manage multiple priorities within a team environment.

Click on apply if this sounds like you!

Becton, Dickinson and Company is an Equal Opportunity Employer. We do not discriminate based on race, religion, gender, or other protected categories.

Learn more at: https://bd.com/careers