Senior Quality Engineer

 

Description:

Convatec, a global leader in medical products and healthcare technologies, is seeking an experienced Senior Quality Engineer – External Manufacturing to join its dynamic team. This role offers a unique opportunity to work with a world-renowned organization that pioneers trusted medical solutions to improve the quality of life for patients across the globe.

Convatec operates in over 90 countries with more than 10,000 employees, specializing in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With annual revenues exceeding $2 billion, Convatec is a FTSE 100-listed company committed to innovation, compliance, and exceptional care.

As a Senior Quality Engineer, you will play a vital role in ensuring the highest standards of product quality, compliance, and process efficiency across Convatec’s external manufacturing network. You’ll work closely with external partners, internal teams, and cross-functional departments to ensure quality excellence, drive process improvement, and support regulatory compliance throughout the product lifecycle.

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Key Responsibilities:

1. Process Improvement & Methodologies

• Drive continuous improvement initiatives using Lean, Six Sigma, and Kepner-Tregoe (KT) methodologies.

• Identify and implement efficiency, quality, and compliance enhancements across product and process lifecycles.

• Lead process improvement projects focusing on New Product Development (NPD) and Cost of Quality (CoQ) optimization.

2. External Manufacturing Support

• Collaborate with third-party manufacturing partners to ensure compliance with quality agreements and project deliverables.

• Participate in supplier site audits and visits to ensure quality assurance for lifecycle management and new product introduction projects.

3. Design Control & Risk Management

• Lead and facilitate risk management activities such as pFMEA and hazard analysis across all product stages.

• Ensure risk mitigation and traceability throughout product development and post-market phases.

4. Product & Process Validation

• Develop and execute IQ/OQ/PQ validation protocols for new and existing products.

• Support test method validation for in-process checks and NPD processes, ensuring critical-to-quality attributes are effectively controlled.

5. Quality Engineering Leadership

• Lead quality engineers (QEs) to deliver multiple projects and workstreams.

• Perform statistical analysis, sampling plans, and capability studies to ensure product quality and compliance.

6. Cross-Functional Collaboration

• Work closely with R&D, Regulatory, Supply Chain, and Manufacturing teams.

• Ensure quality standards are embedded across all phases of product design, development, and lifecycle management.

7. Non-Conformance & CAPA Management

• Lead investigations for non-conformances, complaints, and deviations using structured root cause analysis tools.

• Develop and implement Corrective and Preventive Actions (CAPA) to prevent recurrence.

8. Change Control & Post-Market Surveillance

• Manage product and process change control activities to maintain compliance.

• Support post-launch monitoring using data-driven methods such as PSURs and performance trend analysis.

9. Auditing & Supplier Quality

• Conduct and support internal and supplier audits to ensure compliance with ISO 13485, 21 CFR Part 820, and other applicable standards.

• Oversee supplier performance evaluation and SCAR resolution processes.

10. Quality System & Compliance

• Maintain and enhance quality system documentation aligned with regulatory and corporate requirements.

• Promote a culture of quality, compliance, and continuous improvement within the organization.

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Required Skills & Competencies:

• Strong expertise in Design, Manufacturing, and Third-Party Control processes.

• Excellent understanding of GMP (Parts 201 & 211), ISO 13485, ISO 9001, MDSAP, and 21 CFR 820/803.

• Proficient in TrackWise, SAP, PowerPoint, and statistical tools like MINITAB.

• Experienced in CAPA management, NC handling, and validation processes.

• Skilled in leading audits and acting as a subject matter expert (SME) during regulatory inspections.

• Demonstrated ability to lead multiple projects, coordinate cross-functional teams, and meet critical deadlines.

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Qualifications:

• Bachelor’s degree or equivalent in Science, Engineering, or related discipline.

• Six Sigma Green Belt certification preferred.

• Strong knowledge of quality engineering tools, data analysis, and regulatory compliance in medical device manufacturing.

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Travel Requirements:

• Occasional travel up to 20%, both domestic and international, including overnight stays.

Working Conditions:

• Based in the UK with a remote working structure.

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About Convatec:

Convatec is a global healthcare leader providing innovative medical solutions for patients with chronic conditions. The company’s core mission, “Forever Caring,” reflects its unwavering commitment to improving lives through safe, effective, and high-quality healthcare products.

For more information, visit: www.convatecgroup.com