CAPA Specialist

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 http://www.convatecgroup.com

Responsibilities:

Generate reports from the electronic system to identify reported NC/CAPA’s reported.

Carry out the periodic evaluation of non-conformity and CAPA files to ensure that they are complied with within the established time and complying with quality standards.

Conduct a preliminary investigation of the root cause and be part of the team that generates action plans to attack the identified causes.

Guide and coaching NC/CAPA Owners on the execution and creation of the Root Cause Analysis form

Review and approve research related to quality system improvements. Investigate assigned cases within established deadlines, including sample evaluations, documentation review, staff interviews, trend analysis, etc.

Assist in the electronic updating of non-conformities and CAPA.

Coordinate research support with the affected areas.

To offer training, advice, and support to users of the system.

Execute reports and trend analysis related to distribution center non-conformities, IS non-conformities and CAPAs according to needs monthly and distribute them and notify their supervisor of any adverse report to take immediate action. Participate in or lead NC/CAPA follow-up meetings.

Run monthly reports and trend analysis related to distribution centers and non-conformities according to needs and distribute them.

Participate in forums related to NC/CAPA/SS/HHE

Calculate, evaluate, and guarantee the result of the indicators of the quality management system.

Provide support in the preparation together with his/her supervisor and the other functional areas of Quality of the presentations of weekly and monthly indicator meetings and the semi-annual management review.

Acting as Quality Approver for NC/CAPA

Any other responsibilities assigned by your supervisor.

Demands for education, training and competence:

Bachelor’s degree (industrial area or similar)

1 year of experience in a similar position in medical devices.

1 year handling of systems experiences (NC’s, CAPA, etc).

Communication skills

Verbal and written English required.

Strong computer skills, including Excel, PowerPoint, and Word

Ability to work with electronic databases.

Knowledge of root cause analysis tools required

Familiar/Knowledge on MDSAP (FDA QSR's, J-PAL/Ordinance No.169, ANVISA, AUS, CANADA), required.

Familiar/Knowledge on GMP's and ISO 13485, or similar regulations required. Familiar/Knowledge of EU Medical Device Directive 93/42/ECC, EU Medical Device Regulation (2017/745).

Teamwork and integrity.

Proactive and disciplined.

Focused on results.

Written and verbal communication skills.

Knowledge of data analysis.

Drafting skills and regulatory documentation.

Strategic thinking.

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 [email protected].

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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