Project Quality Sr Engineer

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 10000 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. Convatecs revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit

Main responsibilities:

Supervise the activities of personnel under his/her responsibility.

Evaluate the necessary resources to perform the tasks on respective areas. Identify needs and perform training in the areas for personnel in charge. Develop the personnels skills under his/her responsibility.

Keep communication with other areas in relation to quality problems or improvements (production maintenance engineering logistics suppliers etc.). Promote ideas for continuously improvements of Quality with the end achieve the fulfillment across of the systems simplicity.

Follow up on NCs/PPMs trending as well as VPM

Assure quality monthly report

Review and approve quality specifications documents. Onlines etc.

Process Control related

Oversee and coordination on the investigation related to Process Failures Customer Complaints Other quality issues through his resources.

To make sure that NC process/activities are followed adequately and under applicable procedure.

Review objective evidence to complete investigations and therefore assure correct NC closure and effectiveness.

Issue and NC/CAPA when needed according to procedures established. Participate on Review Board meetings.

Make sure final dispositions are well documented and following the proper procedures.

Support the quality system by being focus on adequate handling of non-conformity activities corrective and preventive actions.

Support to define a classification of all Non-Conformities based upon the risk. Review update and develop procedures instructions quality specification as needed.

Follow up the QA roll as per NC procedure require (for instance Originator Owner Quality Reviewer Approver etc.) as needed.

Support at several areas where his/her experience and technical knowledge about the problem can be usefully (production microbiology systems etc). Lead and keep communication with other departments MX / DK in relation to any quality problem.

Overall participation in projects as main responsibility through the PQEs assuring that regulations or other applicable standards are met.

Support on the risk management system when is needed.

In cooperation with the Engineering department ensure resource and planning for revalidation activities is well handled.

Assure the Filling of validation documentation is following procedures and applicable regulations through the PQE in charge.

Support on review and approval in IQ OQ and PQ validations as well in PSE in all systems applied in collaboration with project leader

Support on review and approval in the management of software validations / test equipment and method validation.

Collaborate on validation of molds and molding machines providing the support as Quality Engineering when is needed.

To comply with the company quality policy.

Qualification & Education

Bachelors degree (Mechanical Electronic Industrial area or similar education) required

Min. 3 years experience on Engineering areas required

Verbal and written English required

Strong Experience on handling of QMS (Quality management system) required Strong Experience on Quality Control Charts (histogram pareto process capability calculations controls charts etc) required

Strong Experience on Quality Management Tools (brainstorms flow diagrams cause and effect diagrams etc.) required

Focus on continues improvement mindset required

Strong to capture describe and communicate ideas to the teamwork preferred Auditor skills preferred

Supervisor experience preferred

Training/Knowledge on MDSAP MDR FDA QSRs and GMPs ISO 13485 J-PAL/Ordinance No.169 EU and Canadian medical devices regulation or similar regulations preferred

Familiar with common computers software packages. MS Office Lotus Notes etc. required

What youll get:

Ready to join us

At Convatec were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.

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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.

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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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