CAPA Engineer

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

Position Overview:

The CAPA Engineer role will be highly visible and will provide leadership in handling of nonconformances/CAPA’s/etc. The role supports key quality system activities such as internal audits, process and product audits, documentation review and the enforcement of Good Manufacturing Practice (GMP) standards. The job holder will demonstrate the highest Quality standards, be able to impart knowledge and increase best practice across site/s, expert in Root Cause Analysis/bounding and will embrace/drive Convatec core mission, values and priorities.

• Supports site/s oversight of the Non-Conformance (NC) and Corrective Action/Preventive Action (CAPA) system.

• Ensures compliance to FDA 21 CFR Part 820, ISO 13485:2016, Medical Device Single Audit Program, and other applicable global Quality System Regulations.

• Leading player within site/s NC/CAPA process including monitoring process performance and implementing continuous process improvement.

• Strategic driver for a world class Nonconformance/CAPA process

Key Responsibilities:

This individual MUST be fluent in both English and Spanish

• Demonstrate methodical problem-solving skills in a fast-paced continuous improvement culture

• Use and promote the benefits of structured and standardized Lean / Six Sigma / KT methodology for process improvement and development

• Work with internal team members cross-functionally and external partners around the globe while maintaining professionalism at all times

• Support internal and external audits

• Experience with medical device manufacturing environment (process lines, testing, inspection) is preferred. A solid understanding of bounding combined with a sound technical aptitude. Nonconformance and CAPA Process:

• Provides continuous and rigorous assessment of site/s NC/CAPA activities and documentation to assure compliance with NC/CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of NC/CAPA records.

• Ensures that NC/CAPA records are routed, reviewed, approved, and implemented in accordance with established procedures.

• Provides guidance, support, and mentors NC/CAPA Owners, NC/CAPA Leads and CAPA Board Members regarding the NC/CAPA process, NC/CAPA best practices, NC/CAPA record content, and NC/CAPA software tools.

• Support NC/CAPA Leads, CAPA Board Members and Executive Management and CAPA Board Members with metrics and reporting on critical aspects regarding the status of the NC/CAPA process.

• Works cross-functionally with a sense of urgency to ensure timely, compliant, and effective NC/CAPA records.

• Participates in Corporate NC/CAPA Board meetings.

• Supports the development and implementation of Quality System NC/CAPA procedures, NC/CAPA software, and NC/CAPA training programs.

• Supports internal and external audits and inspections for NC/CAPA records and processes and other roles as needed.

• Performs other related duties as assigned.

• For TrackWise NC/CAPA Module: Identify and assist with the implementation of updates to the NC/CAPA TrackWise module; including participating in validation efforts e.g., user acceptance testing.

• Develops and reports quality assurance KPI’s as required. Collates quality data and presents for management review.

Required Skills & Experience:

This individual MUST be fluent in both English and Spanish

• Comprehensive understanding in mechanism and key components in Quality Management System

Prior experience working in medical device or pharmaceutical industry

• Bachelor’s Degree in Science, Engineering, or related discipline.

• Knowledge of regulations and standards in the quality management system for Medical Devices, e.g., ISO 13485

• 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 • Minimum 3 years supporting a global Non-Conformance/CAPA process in the medical device or healthcare industry.

• Intermediate to 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.

• Proficient computer skills: MS Office (Outlook, PowerPoint, Word, and Excel), Microsoft Teams, and Adobe Acrobat Pro

• Ability to communicate with diverse teams and functions to foster efficient processes, continuous improvement, and integration across the organization

Other beneficial but not essential:

• Six Sigma Certified Green Belt

• Project Management Experience

• ASQ Certified Quality Auditor Qualifications/Education:

Our progress will give you countless opportunities to move forward too. Seek out new challenges, and you'll find them. Stretch your thinking, and you'll find new ways to make an impact. And if you embrace the opportunity to drive your own growth, you could go further, and achieve more, than ever before.

This is a big step forward.

This is work that'll move you.

#LI-LM1

#LI-Remote

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!