Senior Quality Engineer

2 weeks ago

Ipswich, Suffolk, United Kingdom Maclivaro Limited Full time

Job Title: Senior Quality Engineer

Location: Suffolk, UK

Industry: Medical Device Manufacturing

Salary range: £45,000-50,000

Are you an experienced Quality Engineer with a strong background in the medical device industry? We are looking for a Senior Quality Engineer to join a leading medical device manufacturer in Suffolk, UK. This is an exciting opportunity for someone with expertise in quality engineering to take on key responsibilities in ensuring product quality and regulatory compliance.

Key Responsibilities:

  • Conduct Internal & Supplier Audits: Perform internal and supplier audits in compliance with ISO 13485 standards, ensuring that quality systems and processes meet regulatory requirements and industry standards.
  • Manage CAPA Process: Lead the management of Corrective and Preventive Actions (CAPA) within the medical device manufacturing environment. Identify root causes of non-conformities, implement corrective actions, and track the effectiveness of solutions.
  • Handle Non-Conformance Reporting (NCR): Generate, track, and resolve Non-Conformance Reports (NCRs), ensuring that all non-conformities are documented, addressed, and corrected in accordance with ISO 13485 requirements.
  • Lead Customer Investigations: Conduct thorough customer investigations to address quality concerns and complaints. Provide clear and detailed reports on findings, ensuring customer satisfaction while maintaining compliance with regulatory standards.
  • Oversee Quality Systems Management: Ensure the company's quality management system (QMS) is compliant with ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations. Support the implementation, maintenance, and auditing of the QMS to meet regulatory and quality requirements.
  • Risk Management: Apply risk management principles in line with ISO 14971 for medical devices. Assess, document, and mitigate risks associated with product quality and safety throughout the product lifecycle.
  • Maintain Document Control & Reporting: Ensure accurate and compliant documentation, including CAPA records, NCRs, audit reports, customer investigation reports, and other quality documentation. Follow established document control procedures to meet ISO 13485 standards.
  • Drive Continuous Improvement: Identify opportunities for continuous improvement in quality processes and systems. Utilize process improvement methodologies, such as Lean or Six Sigma, to drive quality enhancements while ensuring compliance with medical device regulations.
  • Perform Data Analysis & Problem Solving: Use statistical tools to analyze data, identify trends, and pinpoint areas for improvement. Employ problem-solving techniques such as 8D, Fishbone Diagrams, and Pareto analysis to resolve complex quality issues and implement corrective actions.
  • Ensure Regulatory Compliance: Stay up to date with medical device regulatory requirements, such as ISO 13485, FDA 21 CFR Part 820, and MDR, ensuring that all products are in full compliance throughout the product development and manufacturing lifecycle.

Key Requirements:

  • Proven experience in a quality engineering role within the medical device manufacturing industry.
  • In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and other medical device regulations.
  • Experience in conducting internal and supplier audits, managing CAPA, and generating NCRs.
  • Ability to lead customer investigations and resolve quality concerns in a regulated environment.
  • Strong background in quality systems management and risk management principles (ISO 14971).
  • Proficient in using problem-solving and data analysis techniques such as 8D, Fishbone Diagrams, and Pareto analysis.
  • Excellent communication skills and the ability to work effectively with cross-functional teams and customers.

This is a fantastic opportunity to further your career in a dynamic and growing industry, where you will play a key role in ensuring product quality and regulatory compliance.

If you are looking to join a team where your expertise will make a significant impact, we'd love to hear from you

Apply today to be considered for this exciting opportunity

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