Lead Validation Engineer
Posted 23 April by
Serve Talent
Location: Suffolk, UK
Company Overview: Join our dynamic client, a leading medical device manufacturing company. They are specialists in developing cutting-edge medical devices that meet the highest quality and regulatory standards.
Position Overview: We are seeking a talented Validation Engineer to join our client in Suffolk. The Validation Engineer will play a critical role in ensuring the reliability, safety, and efficacy of our medical devices through comprehensive validation processes. This role will primarily focus on validation activities, encompassing approximately 80% of the workload, with the remaining 20% dedicated to quality-related tasks.
Key Responsibilities:
- Plan, execute, and document validation activities for new product development, process improvements, and equipment qualifications.
- Develop validation protocols, reports, and procedures in compliance with regulatory requirements and internal quality standards.
- Perform risk assessments and impact analyses to identify validation requirements and ensure the robustness of validation strategies.
- Collaborate cross-functionally with R&D, manufacturing, quality assurance, and regulatory affairs teams to ensure alignment and timely completion of validation activities.
- Provide technical expertise and support during regulatory inspections and audits related to validation processes.
- Participate in continuous improvement initiatives to enhance validation methodologies, processes, and systems.
- Contribute to quality management activities, including non-conformance investigations, CAPA implementation, and internal audits.
- Bachelor's degree in engineering, science, or related field. Master's degree preferred.
- Previous experience in validation within the medical device industry is essential.
- Strong understanding of validation principles, methodologies, and regulatory requirements.
- Proficiency in writing validation protocols, reports, and procedures.
- Excellent analytical and problem-solving skills with meticulous attention to detail.
- Effective communication and interpersonal skills, with the ability to collaborate across functional teams.
- Self-motivated and able to work both independently and as part of a team in a fast-paced environment.
- Knowledge of quality management systems (e.g., ISO 13485) and statistical analysis techniques is advantageous.
- Opportunity to make a meaningful impact on patients' lives by contributing to the development of innovative medical devices.
- Competitive salary and comprehensive benefits package.
- Collaborative and supportive work environment with opportunities for professional growth and development.
- Located in the picturesque county of Suffolk, offering a high quality of life with access to beautiful countryside and coastal areas.
Reference: 52522808
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