Quality Operations Engineer

Quality Operations Engineer

Placering
Osted
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

Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring

The role:
As a Quality Operations Engineer, you will be part of Quality Operations with responsibility for supporting, driving and optimizing improvements in production in close collaboration with process engineers and the production team. Coordinating and leading investigations of Root Cause analyses, Gaps analyses, collect data and trend to improve our product and processes. We can offer you a central role in an exciting company with great growth, where you will have a great influence on the projects and processes of which you will be a part.
You will report to the Quality Operation Manager and become part of a good quality team, which consists of 4 dedicated Quality specialists and 1 Quality

Supervisor with different professional backgrounds. There are also 16 quality assistants working across 5 shifts in production. We have an informal tone on a daily basis and we value highly to have fun.
Your primary place of work is in Osted, south of Roskilde. We offer flexibility to be able to work from home, but your primary workplace will be in Osted to support production.

Your primary area of responsibility will be

• Identify potential improvements and implement concrete solutions.
  • Coordinate quality/production and projects in collaboration with Value stream team.
  • Support several areas where experience and technical knowledge of the problem can be useful (production, systems, process, components, etc.).
  • Coordinate and lead Root Cause investigations with involved team members (maintenance, production, engineering, etc.)
  • Trend analyses, process KPIs (PPMs, NCs, etc.) and prepare actions from them.
  • Prepare and update documentation in collaboration with the Value stream.
  • Effectiveness check and verify implemented solutions.
  • Together with colleagues in the production team, ensure a high level of product quality and production efficiency.

#LI-Onsite

#LI-AN1

This is work that’ll move you.

Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll 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.

Minimum 2 years of experience from medico, pharma or food industry, alternatively other industries with quality/regulatory requirements and associated documentation.

You are educated as ex. Engineer, Process Technologist, Pharmacist, Laboratory Technician or similar.

Qualifications/Education
You have practical experience from production/process optimization and ideally experience with several of the following:
• GMP
• Training
• Hygiene
• Non-conforming product handling
• CAPA / Root cause investigation
• Clean room
• General QA experience
• Manufacturing organizational understanding
• Audit (internal/External)

You must have a "can do" attitude and be ready to challenge the status quo around the company.
You are comfortable with being challenged on ideas and solutions by stakeholders and would here based on analytical skills and data be able to get your solutions safely through process and possible implementation.
You understand that important factors for success are collaboration - and at the same time deliver high quality and timely solutions and deliveries. You are well structured and know when to execute and delegate and how to set the right priorities.

You have good communication skills in Danish and English, both written and oral.

You thrive in an informal culture with great degrees of freedom, a great degree of independence with the opportunity to put your own stamp on your daily work and tasks.

You have strong communication skills and can provide constructive feedback as well as guidance and support to all kinds of levels in the organization.

You are solution-oriented, flexible and have a pragmatic approach and the ability to create and maintain an overview, and at the same time have several tasks going on at the same time.
You must be comfortable using ISO standards, FDA, Eudralex vol. 4, etc. and could use these as a reference work/guidance to ensure decisions are made based on facts and requirements to the company.
It is important that you want to create results through positive and often cross functional collaboration, where you as a team player contribute to ongoing improvements.

You are systematic with a high quality mindset and attention to detail.

To succeed in the role
We expect you to be able to work independently and prepare concrete solutions and improvements.