Quality and Validation Engineer

Description:

Quality & Validation Engineer

An excellent opportunity has arisen for a Quality & Validation Engineer with our medical devices manufacturing client based in Ipswich. They are seeking a professional with a passion for quality and validation in a regulated environment. Join our client as a Quality and Validation Engineer and play a key role in ensuring their products meet the highest standards of quality and compliance. Reporting to the Quality Manager, you will leverage your extensive external experience in testing methodologies and regulatory standards to enhance our validation processes. This role is pivotal in interfacing with customer quality and engineering teams, particularly during trials, and requires strong data analytics skills and expertise in Six Sigma or similar quality approaches.

Responsibilities:

* Develop and implement comprehensive validation plans and protocols.

* Conduct IQ/OQ/PQ validation activities for products.

* Maintain up-to-date knowledge of regulatory standards.

* Prepare and review validation reports for compliance.

* Apply Six Sigma or similar methodologies to improve processes.

* Interface with customer quality and engineering teams.

* Oversee the qualification of new equipment and systems.

Key Role Activities:

* Validation Processes: Develop and implement comprehensive validation plans and protocols. Conduct validation activities including IQ/OQ/PQ for new and existing products. Ensure validation documentation is complete, accurate, and in compliance with regulatory requirements. Coordinate with cross-functional teams to support validation activities.

* Regulatory Compliance: Maintain up-to-date knowledge of relevant regulatory standards and ensure compliance. Prepare and review validation reports, ensuring adherence to regulatory guidelines. Participate in regulatory audits and provide necessary documentation and support.

* Quality Improvement: Apply Six Sigma or similar quality approaches to identify and implement process improvements. Analyse validation data to identify trends, root causes, and areas for improvement. Collaborate with internal teams to develop and implement corrective and preventive actions (CAPAs).

* Customer Interaction: Serve as the primary contact for customer quality and engineering teams regarding validation activities. Coordinate and oversee customer validation trials, ensuring all requirements and expectations are met. Communicate validation results and improvements to customers, ensuring transparency and trust.

* Risk Management: Identify potential risks in validation processes and develop strategies to mitigate them. Conduct risk assessments and implement risk management plans. Ensure all risk management activities are documented and compliant with regulatory requirements.

* Continuous Training: Develop and deliver training programmes for internal teams on validation processes and regulatory requirements. Ensure team members are up-to-date with the latest industry standards and best practices. Monitor the effectiveness of training and update materials as necessary.

* Equipment Qualification: Oversee the qualification of new equipment and systems used in validation processes. Ensure all equipment meets regulatory and quality standards before use. Document all qualification activities and maintain records for audit purposes.

* Supplier Quality: Collaborate with suppliers to ensure the quality of materials and components used in products. Conduct supplier audits and evaluations to ensure compliance with quality standards. Work with suppliers to resolve any quality issues and implement improvements.

Ideal candidate will have the following: -

* Bachelor’s degree in Engineering, Science, or a related field.

* Proven experience in validation within a regulated industry, preferably medical devices.

* Strong knowledge of regulatory standards (FDA, ISO 13485, etc.).

* Proficiency in Six Sigma methodologies or similar quality improvement approaches.

* Excellent data analytics skills with experience using statistical software.

* Strong communication and interpersonal skills, with the ability to interface effectively with customers and internal teams.

What will be offered: -

* A competitive salary and benefits package.

* Career growth opportunities in a supportive environment.

* A role with a significant impact on the company and the environment