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
About the role:
Responsible for the local Quality Engineering function of the Ostomy and Wound Care plants.
Measure and monitor performance against agreed KPIs.
Determine and develop methodologies to achieve specific objectives and business goals (e.g. KPI).
Follow and enforce the corresponding policies and procedures, implementing solutions aligned to the needs of the business and its products.
Work in a multifunctional and multinational environment with the ability to influence others without being their direct authority.
Effectively use engineering knowledge and tools combined with quality systems and regulations to support continuous improvement programs, change control, and complaint handling.
Share information through reports and/or direct communication, following up on identified opportunities.
Actively participate and push for continuous improvement of the plant's quality system.
Key Duties and Responsibilities:
Manage the Quality Engineering organization in Haina (Ostomy and Wound Care Plant)
Direct and plan the tasks of quality engineers to meet change control requirements and validations of existing, transferred, and new products and processes, as well as test methods.
Review and approve Validation Packages ensuring compliance with procedures and regulations.
Identify, develop, and implement continuous improvement projects for products and processes.
Responsible for managing the life cycle of products based on risk management.
Responsible for the Validation Master Plan.
Defend validation and risk systems during internal and external audits.
Carry out, together with your team and if required, CAPA (Corrective and Preventive Actions).
Provide support to the plant during internal and external audit processes.
Skills and Experience:
Knowledge And Understanding Of Validations And Qualifications Principles.
Six Sigma Certification (Green Belt or Black Belt), preferred.
Knowledge of Project Management, preferred.
Knowledge and experience, of at least 2 years of change control principles and associated processes.
Knowledge of complaint handling, CAPA and associated processes.
Ability to use statistical techniques to identify robust processes and improve existing processes, preferred.
Qualification and Education:
Degree, preferably in Engineering
Fluent English
At least 3 years of minimum experience in a leadership role, preferably in the Medical Device or Healthcare industry.
At least 5 years working in the medical device industry and regulatory requirements including QSR, ISO 13485
Travel Requirements - approximately 10% of your travel time is required to other plants, customers and or suppliers.
What you'll
g
et:
- Competitive salary + bonus
- Training & development
- Collaborative, supportive culture
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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.
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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 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.
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