About Convatec
Pioneering trusted medical solutions to improve the lives we touch: 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. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. 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 http://www.convatecgroup.com
Pioneering trusted medical solutions to improve the lives we touch: 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 around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
Position Overview:
The Quality Improvement Engineer plays a key role in supporting the Quality Improvement Team and serves as a critical business partner by providing both strategic and tactical support to the organization. This role focuses on optimizing processes that directly impact product and process quality, with a strong emphasis on data analytics, metrics, and key performance indicators (KPIs). The engineer will contribute to continuous improvement initiatives and drive data-based decision-making across the organization.
Key Responsibilities:
Apply structured problem-solving methodologies (e.g., Lean, Six Sigma, Kepner-Tregoe) to drive continuous improvement initiatives in a dynamic environment.
Lead and support cross-functional projects aimed at optimizing quality system processes, ensuring compliance with global regulatory requirements.
Collaborate with internal stakeholders and global partners to implement best practices and standardized solutions.
Develop, revise, and maintain controlled documents such as SOPs, Work Instructions, and training materials to reflect process improvements and regulatory updates.
Manage and publish metrics and KPIs according to defined schedules, ensuring data integrity, traceability, and compliance with standards such as ISO 13485.
Utilize data analytics tools (e.g., Power BI, Excel, R, Minitab) to support decision-making, reporting, and performance monitoring.
Support internal and external audits by ensuring readiness and compliance of owned processes.
Drive the transition from manual or paper-based systems to digital/eSystem solutions, including automation of data collection and reporting.
Evaluate existing processes, define project scopes, estimate resources, and lead implementation of approved improvement initiatives.
Initiate and manage change control records for local or global process changes, ensuring proper documentation and regulatory alignment.
Responsible for publications of metrics, KPIs to an agreed schedule as defined by direct Management.
Ensure that data analytics, metrics, and KPIs are properly proceduralized, standardized, and compliant with applicable regulations and international standards (e.g., ISO 13485), as defined in Management Review requirements.
Utilize manual, semi-automated, and fully automated tools (e.g., Power BI, Minitab, Excel, R) to compile, verify, and publish performance data according to established schedules.
Lead or support quality system optimization initiatives, including:
Development of data analysis and reporting solutions (manual to fully automated).
Transition of paper-based processes to electronic systems (eSystems).
Evaluation of existing processes, definition of project scope, resource estimation, and execution of approved improvements.
Drafting or updating Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure compliance with regulatory requirements.
Management of change control records for both site-specific and global process changes.
Skills & Experience:
Knowledge of key regulatory standards (QSR 820, ISO 13485, MDR, ISO 9001, GMP Parts 210/211) and ability to support compliant systems.
Experience supporting process and system changes through project coordination.
Understanding of documentation control, change management, and their impact in regulated environments.
Familiarity with quality system elements: Non-conformance, CAPA, Change Control, Documentation, and Management Review.
Ability to collaborate across functions and with stakeholders to improve processes.
Strong organizational skills with the ability to prioritize and work independently.
Analytical mindset to assess complex issues and propose practical solutions.
Risk and issue identification with timely escalation when needed.
Stakeholder-focused, with the ability to incorporate feedback effectively.
Solid communication and presentation skills and strong team player.
Qualifications/Education:
Bachelor’s degree in Engineering, Life Sciences, or a related technical field (required).
Minimum 2 years of experience in the medical device or healthcare industry, with a focus on Quality Management System (QMS) improvement.
Proven knowledge of regulatory requirements applicable to medical device manufacturing (e.g., QSR 820, ISO 13485, MDD/MDR, ISO 9001, GMP Parts 210 & 211).
Training or certification in auditing practices (preferred).
Training or certification in Power BI or data analytics tools (preferred).
Working Conditions
This is a remote position, but office presence will be required or allowed for certain meetings, events, or to meet certain business needs.
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
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#LI-Remote
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.
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 predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!