Principal Quality Engineer

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 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit

Position Overview:

Provides oversight for the development and maintenance of quality programs, systems, processes and operational procedures that ensure compliance with policies and regulatory standards. Responsible for supervising quality associates, conducting and overseeing quality assurance and quality control, and collecting, analyzing, and interpreting records results. Prepares reports and/or necessary documentation (e.g. Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

Key Responsibilities:

· Provides oversight for the development and maintenance of quality programs, systems, processes and operational procedures that ensure compliance with policies and regulatory standards.

· Responsible for supervising and mentoring the quality associates, conducting and overseeing quality assurance and quality control, and collecting, analyzing, and interpreting records results.

· Develop, enhance, and revise operational procedures and work instructions to support and ensure systems within area of responsibility are in compliance.

· Ensure that all nonconformance product is in compliance with applicable operational procedures and regulatory requirements.

· Support the development of Quality, Operations and Quality Operations strategies both locally and globally.

· Responsible of technical support in business-related quality issues within quality system (e.g Corrective and Preventative Actions, Nonconformance reports, customer complaints, etc) as well as the nonconformance appropriate disposition

· Maintains effective working relationships with internal and external customers to establish quality standards prior to initial production, and to resolve technical and business-related quality issues within quality system (e.g Corrective and Preventative Actions, Nonconformance reports, customer

complaints, etc) .

· Ensure the Device History Records are in compliance with the internal operational procedures. Lead the audit process for finished goods and feedback to areas on the results of the audits.

· Support and collaborate with stakeholders and cross functional team to resolve quality related issues to meet shared objectives and responsibilities. · Actively participate in continuous improvement efforts for existing products, processes, and services. · Select, evaluate, coordinate, and develop employees under supervision to achieve company objectives within the most effective plan.

Skills & Experience:

· 5-7 years of experience in medical device manufacturing or pharmaceutical companies.

· Standards knowledge such as ISO 13485: 2003/CFR 820.

· Experience working in clean and/or controlled rooms.

· Knowledge of complaint handling, NC, CAPA and/or associated processes.

· Ability to train and conduct Quality System audits.

· Problem solving-Corrective and Preventative Actions, and statistical techniques.

· Analytical and Mathematical Skills.

· Critical thinking and attention to details.

Qualifications/Education:

· Bachelor’s degree in industrial engineering or related careers.

· Preferred, Lean Six Sigma Green Belt Certification

· Preferred, Certifications in Quality Management Systems (e.g. Lead Auditor 13485, EU MDR, MDSAP, etc)

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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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