Principal Specialist - Design Control and Risk Management

Join Our Team at Coloplast!

Are you passionate about ensuring the highest standards of quality in medical devices? Do you thrive in a collaborative environment where your expertise can make a real difference? At Coloplast, we are dedicated to improving the lives of people with intimate health needs, and we are looking for a Principal Design Control Specialist to join our team.
 

About the Role:

As the Principal Specialist for Design Control and Risk Management, you will be responsible for the continuous support and development of our global quality processes across multiple business areas, including Ostomy Care, Chronic Care, Wound & Skin Care, Continence Care, Consumer Business, and Interventional Urology.

As a Principal Design Control Specialist, you will play a pivotal role in maintaining compliance with global quality standards, particularly ISO 14971 and EN 13435. You will work closely with cross-functional teams to develop and enhance our quality processes within Design Control and Risk Management, ensuring they meet both regulatory requirements and the organizational needs. Your decision-making authority will empower you to implement effective processes that drive quality and innovation.

“Being the global process owner of Risk Management and Design Control means you will combine your specialist knowledge across the company. No two days are the same as you collaborate with various stakeholders to keep us aligned with current regulations and guidelines,”  - Malene Schack Jørgensen, Head of Stability, Packaging, and Design Control.

Key Responsibilities:

• Process Ownership: Serve as the owner of the Design Control and Risk Management processes, providing expert advice and support across all areas of Coloplast.

• Champion Compliance: Ensure our global quality processes align with ISO 14971 and other relevant standards, safeguarding product quality and patient safety.
• Communication: Communicate process changes and updates effectively across the organization.
• Drive Continuous Improvement: Collaborate with teams to support and evolve our quality processes, fostering a culture of excellence and innovation and product lifecycle management within our organization.
• Documentation: Contribute to the preparation of key documents, including rationale for test methods, product descriptions, and change controls.
• Empower Others: Develop comprehensive training materials and provide engaging training sessions across functions, sharing your knowledge and insights.
• Collaborate Across Functions: Work hand-in-hand with R&D, Lifecycle Management, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing etc. to drive successful outcomes within design control and risk management.

What We’re Looking For:

Educational background:

•  A Master’s degree in Engineering, Life Sciences, or a related field.

Experience: 

• 10+ Experience in the medical device or pharmaceutical industry with a focus on Quality Management Systems, design processes, and risk management.
• 5+ years working specifically with design control within the medical device industry, with a strong understanding of ISO 14971, and regulatory standards.
• Comprehensive knowledge of relevant external requirements (e.g., FDA, MDD/MDR, ISO). Experience with audits and inspections.

Skills: 

• Exceptional analytical and problem-solving abilities, along with excellent communication and interpersonal skills. Proven ability in stakeholder management, process optimization, and cross-cultural communication. Fluency communicate in English, as is our cooperate language.
• A team player with a collaborative mindset and the ability to work effectively across diverse teams, embodying our "one company" philosophy.

The Team:

As part of our Global Quality, Regulatory Affairs, and Sustainability department, you will work alongside a dedicated team of five Design Control Specialists. The Design Control Specialists are part of the Stability, Packaging, and Design Control department, which also includes specialists within stability, packaging and transportation.

Our project-based approach means you will engage with colleagues across different functions, guiding and supporting them in the design control process for each project, both in the R&D organization and in Lifecycle Management.

Why Coloplast?

At Coloplast, we believe in a culture of collaboration, respect, and innovation. We offer a supportive environment where your contributions are valued, and you have the opportunity to grow your career. Join us in making a meaningful impact on the lives of individuals around the world.

At Coloplast, we aim high, empower our employees, embrace inclusivity, and strive for simplicity in everything we do.

Ready to Make a Difference?

If you’re excited about the opportunity to contribute to our mission and meet the qualifications outlined above, we encourage you to apply today! Together, we can shape the future of healthcare.

Interested? 

If you would like to know more about the position, please call Malene Schack Jørgensen, Head of Stability, Packaging and Design Control at +45 4911 3064. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate is found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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