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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

Participate in changes within the project portfolio in Sustaining Eng. Group, and hereby achieve:

• Compliance with internal and external requirements according to standards, customer, and authorities

• Ensure quality system is developed, maintained, and improved.

• Assure Process Validation and Change Control Request system is followed accordingly.

• Support as leader on quality issues or non-conformities raised from the project-change.

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.

• Responsible for identifying all affected documents on a change/project (DMR).

• Participate in design review and design examination.

• Review protocols and reports (documentation) regarding verification/validation processes, in applicable phases.

• Obligated to prevent the occurrence of risk ad of adverse impact on product quality, function, performance, usability, safety, and its intended use.

• Responsible for Sterilization Evaluation Report.

• Act as advance impact assessor in a CCR.

Requirements

• Bachelor’s degree in engineering or similar technical education (required)

• Min 3 years on expiring working in similar position (preferred)

• Experience from Medical Device Industry or other regulated industry (preferred)

• Experience with cross organizational projects (preferred)

• Knowledge of process validation (required)

• Fluent in oral and written English (required)

• Experience on measurement techniques, root cause investigation and statistics (required)

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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!