Senior Manager, QA, Supplier Quality Management (SQM)

About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.

On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.

Want to know more about our mission and vision? Click on the link: Link of YouTube video

Our people

At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.

If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.

Description

The QA team has a significant role in securing reliable and compliant products during production, storage and shipping of products. This is done by cooperating, supporting, facilitating, training and communicating towards obtaining the best results with partners in Supply Chain, Operations, Warehousing and supporting functions at the site in DK as well as the US and Polish production sites.

The position is located in Denmark and reports to Director, QA Engineering and Operations. QA Engineering and Operations is a department with 25 employees divided into 5 teams.

Key Responsibilities for the team

You take responsibility for a team of 3 employees, that ensure compliance to regulatory requirements for Supplier Quality Management in corporation with the Sourcing and Supplier teams in Manufacturing.You and the team owns the global QA SQM process to approve and monitor suppliers in close corporation with Sourcing. The team is newly established and you can expect to help with building relations cross-functionally and with your understanding of how QA processes supports and impact the business. Stakeholders also include Operations, R&D and Management along with our production sites in Finland, Switzerland, US and Poland.

Your Responsibilites

• Partner with Sourcing organization to ensure continuous compliance to ISO 13485:2016 requirements and other relevant regulations and ensure efficient QA processes.
• Drive writing and maintaining Quality Agreements with Contract Manufacturers, Suppliers and Distributors.
• Be part of Supplier audit team and perform Supplier Audits as lead auditor.
• Drive global QA SQM activities.
• Collaborating closely with Operations management to ensure timely and compliant product deliveries.
• Use a lean process view to constantly improve quality processes to become efficient, lean and in compliance with regulations.
• Drive Supplier Quality Management team meetings.
• Participating in quality training activities.
• Keep updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.
• Providing guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.

Contribute, grow and develop

Radiometer is a growing organization always developing through LEAN management tools and values. It makes it fun and meaningful to be part of an organization where your thoughts and ideas are embraced by management and can make a true impact. Developing on a personal and professional level is of a high importance for everyone in Radiometer and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher.

Application deadlineApplication deadline is Monday 7 October 2019. Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents. We look forward to receiving your application.For further information, please contact Peter Høgh, at [email protected]

Qualifications

We believe that a background as engineer, pharmacist or similar will be a valuable asset in the job as well as:

• Minimum 5 years’ experience with Supplier Quality Management within Medical Devices or Pharma.
• Experience and practical knowledge about quality assurance for medical device products and components
• Broad process knowledge (production as well as R&D experience) preferred.
• Experience with performing Quality Agreements and Supplier Audits
• Experience with component classification and Supplier approval
• Knowledge of regulatory demands and standards: MDD/MDR, IVD/IVDR, ISO 13485, MDSAP, FDA legislation
• Work Experience from other Medical Devices or IVD companies in a similar role
• Lead Auditor in 13485:2016

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

Organization: Radiometer
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule: Full-time

Kilde: Jobnet.dk