Remediation CAPA 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 10,000 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. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

The role:

The Remediation CAPA Engineer supports the execution and remediation of the Nonconformance (NC) and Corrective and Preventive Action (CAPA) process under the direction of Quality Systems leadership. This role focuses on supporting compliance with applicable Quality System requirements, including FDA 21 CFR Part 820, ISO 13485:2016, MDSAP, and internal procedures, by assisting with the review, correction, and progression of NC and CAPA records.

The position supports remediation activities by preparing and updating NC/CAPA records, supporting data analysis, assisting with TrackWise system activities, and helping address overdue, high‑risk, or inspection‑critical records. The role works cross‑functionally and across sites to support timely, consistent, and compliant execution of NC/CAPA remediation actions

Key Responsibilities:

• Supports remediation and execution of Nonconformance (NC) and CAPA activities in accordance with established procedures and global regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485).
• Reviews NC and CAPA records for completeness, accuracy, and procedural compliance, and supports timely routing and progression of records.
• Provides hands‑on support to NC/CAPA Owners and Leads on record content, remediation expectations, and appropriate use of the NC/CAPA system.
• Prepares metrics, reports, and data summaries to support oversight by Quality Systems leadership and CAPA Review Boards.
• Supports cross‑functional teams with remediation of high‑priority, overdue, or inspection‑critical NC and CAPA records.
• Participates in NC/CAPA escalation and board meetings in a supporting role, including status updates and follow‑up of assigned actions.
• Assists with NC/CAPA TrackWise system activities, including data clean‑up, user support, and validation tasks (e.g., user acceptance testing), as assigned.

Skills & Experience:

• Comprehensive understanding in mechanism and key components in Quality Management System.
• Knowledge of regulations and standards in the quality management system for Medical Devices, e.g. ISO 13485.
• Effective at problem solving and data analysis (trending) while maintaining attention to detail.
• Knowledge of Statistical techniques and application of those
• Willingness to adhere to all principles of confidentiality.
• Comfortable working in a highly regulated, fast-paced environment.
• Effective and proactive communication, particularly in a remote-working situation.

Qualifications/Education:

• Bachelor’s Degree in Science, Engineering, or related discipline.
• Minimum 5 years supporting a Non-Conformance/CAPA process in the medical device or healthcare industry.
• Expert skill level utilizing TrackWise.
•  Knowledge of and the ability to translate and apply the requirements of ISO 13485:2016,
• 21 CFR Part 820, and the Medical Device Single Audit Program (MDSAP).
• Ability to deal with difficult situations with tact and professionalism.
• Ability to communicate effectively in both oral and written communications, and work with employees at all levels of the organization.
• Demonstrate problem solving and trouble shooting skills.
• Ability to work without close supervision and produce quality work.
• Strong computer skills: MS Office (Outlook, PowerPoint, Word, and Excel), Microsoft Teams, and Adobe Acrobat Pro.

Principal Contacts & Purpose of Contact

• Internal – Global Site NC/CAPA Leads, Site Quality Leads, Compliance, Quality Engineers, Manufacturing Engineers and personnel.
• External – None. 

Travel Requirements

• 30-50% domestic/international travel may be required; this may include overseas travel. Most trips will include overnight travel.

Languages

• Speaking: Yes English / Spanish

• Writing/Reading: Yes English / Spanish

Working Conditions

This is a hybrid position with office presence is required based on activities been executed. 

Ready to join us?

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re 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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