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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 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit our website.
At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Quality Systems Manager, and you’ll do the same.
About the role:
This function is responsible for the management and oversight of the Quality Systems. Responsible for developing, identifying, analyzing, and improving the quality system. This process will follow the ConvaTec Quality Management Systems, as well as applicable regulations and standards (e.g. 21 CFR Part 820, ISO13485, Japan MO-169, Brazil ANVISA).
The position requires empowerment and proactivity, time management skills, organization, and attention to detail. The role will have interaction and/or communication, when applicable, with employees, customers, suppliers, and third parties.
Your key duties and responsibilities:
- Supervise the Quality systems team and their support to both Advanced Wound Care plants.
- Assist and coach the teams in conducting investigations of trainings, document activities, complaints, non-conformities, and/or corrective preventive actions.
- Oversee the complaint system, assuring corresponding evaluations and/or investigations are completed in a timely manner, trends are analyzed, and applicable actions are executed (e.g. CAPAs, SS, HHE).
- Report progress of investigations for complaints, non-conformities, preventive/corrective actions, internal/external audits, stop shipments, HHEs, supplier quality, and any other applicable Quality System requirement.
- Oversee the CAPA system, assuring corresponding investigations, corrections, containment, and corrective/preventive actions are taken, as well as ensuring that their effectiveness is measured; this while also maintaining a system that complies with QMS requirements.
- Oversee the training and document management system, assuring corresponding activities, trainings, evaluations and/or investigations are completed in a timely manner, trends are analyzed, and applicable actions are executed.
- Execute/report/analyze trend analysis related to the quality management system.
- Participate in local and/or corporate meetings representing the site Quality System and communicating any actions/activities that are needed.
- Oversee/prepare corresponding reports and/or meetings (e.g. trend analysis, management reviews) to assure the Quality System is robust and complies with requirements, and, if applicable, raise corresponding actions to keep in compliance.
- Manage the Quality Audit Process. Oversee/prepare the schedule and coordination of both internal audits and external audits. Conduct audits and support auditors. Conduct audits according to the program and communicate their results. Report non-conformities found during audits. Prepare and submit audit reports.
- Lead external audits and certification programs.
- Support and participate in company projects.
- Identify, develop, and implement continuous improvement projects for products and processes.
- Carry out, together with your team and if required, CAPA (Corrective and Preventive Actions).
- Follow and enforce the corresponding policies and procedures, implementing solutions aligned to the needs of the business and its products.
Skills & Experience:
- Seven (7) to ten (10) years in the medical devices industry in leading positions.
- 1 year experience in management/principal positions (preferred).
- Experience in leading front or back rooms during external regulatory body audits.
- Experience leading external audits in sister plants (preferable).
- Experience with submitting local registrations (preferable).
- Experience leading investigations of audit findings (preferable).
- Experience in executing training programs (preferable).
- Experience with QMS regulated software.
- Knowledge of change control principles, quality systems, training, standards, and regulations of Medical Device Quality systems.
- Demonstrated proficiency in complaints, non-conformance, and CAPA management.
- Skill in root cause analysis, continuous improvement, and statistical tools.
- Strong motivation to achieve good results is essential. Self-directed leadership, requiring minimal supervision and proactive attitude.
Qualifications/Education:
- Bachelor’s degree in industrial engineering, business administration (desirable), or any other related field.
- Knowledge of the Quality Assurance standards for medical devices like ISO13485 and 21 CFR 820.
- Knowledge of root cause analysis tools.
Working Conditions:
- Site-based at Deeside Manufacturing site.
- Work on weekends may be required based on business needs.
Travel Requirements:
- You will be expected to travel an estimated 5% -10% of the time, mainly to different Convatec plants.
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge. This is work that’ll move you.
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!
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