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. Group revenues in 2022 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

About the role

Representing Quality Management, actively contributes to the development of New Products within the new product development process. Responsible for ensuring that Design Control requirements including development of Design and Development plans meet regulatory and applicable procedural requirements. Responsible for reviewing and approving design control document outputs. Works closely with Manufacturing QE’s to assure appropriate Validation Planning and a robust Design Transfer.

Key responsibilities

• Update and develop quality procedures, quality specifications as required in the project-change.

• Draw up and/or follow up on internal deviations, rationales, statements, and preventive actions. Supporting the quality system in the adequate handling, for instance, non-conformities activities, CAPA activities.

• Responsible for Updating Risk Management Plan, including Use/Design FMECA and Process FMECA within a new project/change.

• Takes responsibility for the measuring and monitoring of performance against agreed KPIs.

Requirements

• Bachelor’s degree in Industrial Engineer.

• Experience from Medical Device Industry or other regulated industry.

• Minimum 3 years of experience working in similar position. Demonstrated knowledge of Regulatory and GXP Compliance requirements such as QSR Part 820, MDD 93/42, GMP Parts 210 and 211, ISO 9001 / ISO 13485. Demonstrated knowledge and experience of Risk Management.

• Must be proficient with PC programs, i.e. Excel, Word, and PowerPoint.

• Fluent in oral and written English.

• Availability to work on-site.

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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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