Senior Manager, Quality Engineering

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

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 as Senior Manager, Quality Engineering, and you won’t either.

 

Do you have what it takes to lead a Quality Engineering team consisting of Validation Engineers, Quality Compliance Engineers, and Product Quality Engineers for our Infusion Care Business Unit? Are you experienced in ensuring risk management, validation approach, and procedure for statistical methods are in compliance with Quality Assurance and Regulatory Affairs?

Do you want to join a world leading company specializing in treatment of chronic diseases such as Diabetes and Parkinson’s Disease? Then you might be our new Senior Manager, Quality Engineering.

About the role

As our Senior Manager, Quality Engineering, you will be responsible for ensuring simplification of procedures and processes, driving efficient and operational systems and procedures and alignment with our manufacturing site in Reynosa, Mexico, and contributing to quality awareness within the wider organization by supporting the global quality team with creation, consolidation and simplification of strategies and company quality programs /projects.

You will report to the Senior Director, Quality, and be part of our Global Quality organization with a strong professional foundation. The primary workplace is in Osted, Denmark and this is an onsite position.

Key responsibilities

This position will serve as deputy for all members of the Product Quality Engineering and the Quality Engineering teams. It encompasses management of Quality Engineers, coordinating involvement in validations, advanced operations projects and life cycle management. This position requires strong communication / collaboration / leadership skills, and English language is a must-have.

Additional responsibilities include:

• Identifying, hiring, training, and maintaining qualified personnel in the quality engineering team to support quality goals and objectives.
• Ensuring adequate communication/information form the Quality Engineering group to Quality Assurance and Regulatory Affairs department regarding projects, thereby ensuring coordination of tasks.
• Review and approval of documentation regarding risk management, verification and /or validation within a project concerning process facilities.
• Ensuring the input from relevant groups are accounted for in the Risk
• Management system and ensuring Product Risk Review is held according to plan.
• Participating in notified Body and customer audits and ensuring timely handling of Non-conformances within own area.
• Acting as Quality Approver for Non-conformances and CAPAs.

Travel Requirements

The position will involve travel up to 25% of the time, and most trips will include overnight travel.

Education/Qualifications

• A master’s or bachelor’s degree in engineering, chemistry, biology, pharmacy or similar.
• Minimum of 5-7 years’ experience with Quality Assurance from the medical device or pharmaceutical  Industry.
• Experienced within Risk Management Quality Compliance and Validations.
• Minimum of 5-7 years’ experience in standards and regulations within the medical device or pharmaceutical industry (ISO 13485, ISO 17971 and ISO 11607).
• Fluent English, verbal and written (required)
• Demonstrated record of building high performance teams.
• Demonstrated record of working successfully within a matrix environment.

Working Conditions:

This is an onsite position, based in our Osted, Denmark site.

Language Skills Required:

Speaking:                          Yes                       English

Writing/Reading:            Yes                       English

 

About us

We offer you a position in a dynamic and global company with great benefits and fle