Job Description

About Us
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a FTSE 250 global medical products and technologies company, focussed on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence and critical care, and infusion care.
Group revenues in 2021 were over $2 billion. With around 10,000 colleagues, we provide our products and services in over 100 countries, united by a promise to be forever caring. Our products provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. To learn more about Convatec, please visit http://www.convatecgroup.com

Change is everywhere at Convatec. It\xe2\x80\x99s transforming our business, and helping us improve millions of lives. And we\xe2\x80\x99re nowhere near finished. Across every part of our business, we\xe2\x80\x99re pushing for better.
Join us on our journey to #ForeverCaring as a CAPA Engineer, and you\xe2\x80\x99ll do the same.

Job Summary

• 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

In the CAPA Engineer role you will be highly visible and will provide leadership in handling of nonconformance\'s/CAPA\xe2\x80\x99s/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.

Key Duties and Responsibilities

General Expectations:

• 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 Event/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\xe2\x80\x99s as required. Collates quality data and presents for management review.

Principal Contacts

• Internal \xe2\x80\x93 Global and Site NC/CAPA Leads, Site Quality Leads, Compliance, Information Management, and Executive Management
• External \xe2\x80\x93 External Auditors and Inspectors, Regulatory Agencies, and Notified Bodies
• Operations (Manufacturing)
• Engineering \xe2\x80\x93 Site and Quality
• Regulatory Assurance
• Supply Chain
• Technical including GDC Deeside
• Research and Development
• Advanced Operations
• Supplier Quality
• Global compliance

Travel Requirements

• A small amount of travel will be involved with this role, 20% maximum.
• This may include overseas travel. Most trips will include overnight travel.

Language Skills Required

• English - Fluent/Native speaker

About You

• 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
• 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

• Bachelor\xe2\x80\x99s Degree in Science, Engineering, or related discipline.
• 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 organisation.

Other beneficial but not essential

• Six Sigma Certified Green Belt
• Project Management Experience
• ASQ Certified Quality Auditor

Working Conditions

Provide brief overview of the typical working conditions for this position.

Examples:

• The position may involve time within a clean room manufacturing facility which produces medical device and wound care products. Use of proper safety glasses and safety shoes is required.
• Working in an Office environment with some Hybrid Office rules on occasion. Predominantly required onsite however, there may be requirements to work remotely on occasion.

Special Factors

Flexibility and Agility to adapt to pressure and time constrained situations

Our transformation will change your career. For good. You\xe2\x80\x99ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you\xe2\x80\x99ll be supported to bring them to life. There\xe2\x80\x99ll be
challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet.

This is stepping outside of your comfort zone.
This is work that\xe2\x80\x99ll move you.

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\xe2\x80\x99re unsure, please contact us at .

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!

Convatec