Senior Quality Engineer - External Manufacturing

Rhian_Convatec; City Of London; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading medical technology company is seeking a Senior Quality Engineer in London to ensure compliance and maintain high-quality standards across external manufacturers. This role involves collaboration with various teams, driving continuous improvement initiatives, and managing quality systems. Candidates should have a degree in a related field and significant experience in quality engineering or the medical device industry.

Qualifications

• Minimum 5+ years in a similar role, preferably within the medical device industry.
• Competent auditor with experience in hosting or acting as SME during external regulatory audits.
• Experience in implementing/reviewing pFMEA.

Responsibilities

• Drive continuous improvement using Lean and Six Sigma methodologies.
• Collaborate with external manufacturing partners to ensure compliance.
• Lead risk management activities throughout the product lifecycle.
• Support post-launch reviews and monitor product performance.

Skills

Proficient in design, manufacturing and third-party control processes

Understanding of complaint handling systems

Knowledge of TrackWise, PowerPoint and SAP

Strong interpersonal skills

Ability to lead multiple projects

Education

Degree in science, engineering, or related discipline

Six Sigma Green Belt qualification

Tools

MINITAB

Job description

Overview

About Convatec

Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit convatecgroup.com.

About the role

A senior member of the External Manufacturing Quality Engineering team performs a vital role in maintaining the highest levels of quality and compliance. This role will collaborate across organisational boundaries to support new production commercialisation, life cycle management of existing base business at external manufacturers and lead continuous improvement activities at external manufacturers to assure continued product Quality and Regulatory compliance as well as driving reduction of quality related issues.

This role ensures the application of appropriate controls and processes and reviews the enforcement of Good Manufacturing Practice (GMP) standards within external manufacturers. It supports quality initiatives and evaluates engineering elements, instigating improvements where needed through problem solving and other quality system elements. The role is focused on driving towards right first time and will lead external manufactured projects.

The role also supports the Quality Manager, External Manufacturing and associated project teams/business units by providing oversight and guidance in External Manufacturing operations, ensuring continuous GxP compliance and adherence to procedural requirements.

Your key duties and responsibilities

Process Improvement & Methodologies

• Active drivers of the use of structured problem-solving tools such as Lean, Six Sigma, and Kepner-Tregoe (KT) to drive continuous improvement and process development.
• Identify and implement opportunities for efficiency, quality, and compliance enhancements across product and process lifecycles.
• Lead and drive toward new product development (NPD) with a Process improvement and Cost of Quality focus.

Third-Party Manufacturing Support

• Collaborate with external manufacturing partners and T&I to ensure compliance with Quality Agreements and delivery of NPD projects.
• Participate in supplier site visits and audits to support project execution and quality assurance for LCM and NPD projects.

Design Control & Risk Management

• Lead and facilitate risk management activities (e.g., pFMEA, hazard analysis) throughout the product lifecycle, from development through post-market.

Product & Process Validation

• Contribute to the development and execution of validation protocols (IQ/OQ/PQ) for new and existing products and processes.
• Support test method validation for in-process checks and NPD development methods to ensure critical-to-quality (CTQ) attributes are defined and controlled.

Quality Engineering Support

• Lead QEs to deliver projects and various workstreams.
• Lead and perform statistical analysis, sampling plans, and capability studies to support product development and manufacturing.

Cross-Functional Collaboration

• Work closely with R&D, Manufacturing, Regulatory, procurement, and Supply Chain teams to ensure quality is embedded in all phases of product development and lifecycle management.
• Lead cross-functional teams in implementing process improvements and resolving quality issues.

Non-Conformance & CAPA Management

• Investigate product and process non-conformances, customer complaints, and deviations using root cause analysis tools.
• Develop and implement effective corrective and preventive actions (CAPAs) to prevent recurrence.

Change Control & Post-Market Surveillance

• Lead product and process change control activities, ensuring compliance with regulatory and internal requirements.
• Support post-launch reviews and monitor product performance in the market using data-driven approaches such as PSURs.

Auditing & Supplier Quality

• Support internal and supplier audits to assess compliance with ISO 13485, 21 CFR Part 820, and other applicable standards.
• Support supplier quality management activities including onboarding, performance evaluation, and SCAR resolution.

Quality System & Compliance

• Maintain and improve quality system documentation and processes to ensure regulatory compliance and alignment with site and corporate KPIs.
• Promote a culture of quality and compliance across the organization.

Skills

• Proficient in design, manufacturing and third-party control processes and procedures.
• Understand complaint handling systems in conjunction with 21 CFR 820 and 803 as well as ISO 13485, MDSAP knowledge, ISO 9001, GMP Parts 201 and 211.
• Knowledge and experience of TrackWise, PowerPoint and SAP; MINITAB preferred.
• Knowledge and experience in leading and managing changes internally and externally.
• Strong SAP and validation procedures knowledge.
• Strong interpersonal skills with cross-functional project deployment experience.
• Practical working knowledge of change control and all aspects of the process and computer systems validation lifecycle (preferred).
• Demonstrated ability to lead multiple projects and motivate cross-functional teams while meeting deadlines.

Experience

• Minimum 5+ years in a similar role, preferably within the medical device industry but not essential.
• Strong knowledge and experience of CAPA and NC.
• Competent auditor with experience in hosting or acting as SME during external regulatory audits.
• Experience in implementing/reviewing pFMEA.

Qualifications/Education

• Degree or equivalent in science, engineering, or related discipline.
• Six Sigma Green Belt qualification and/or demonstrated ability in quality engineering tools and techniques (quality core tools) and data interpretation.
• Regulatory and compliance knowledge of validation.
• Knowledge and experience of working with a Quality Management System within Medical Device manufacturing.

Travel Requirements

• The position may involve occasional travel up to 20%, both domestically and overseas. Most trips will include overnight travel.

Working Conditions

• This role may be based in the UK with a remote working structure.

Ready to join us?

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

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Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposition characteristics or any other basis prohibited by law.

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