Are you passionate about (re)designing processes and creating process flows, and do you have experience within the Life Science industry, and especially within supplier management and audits? Then you might be the person we are looking for to us on our compliance journey at our production site in Roskilde, Denmark.
As our new Senior QMS Quality Engineer you will be part of the Quality Management Systems (QMS) department with reference to the QMS Manager. The QMS department is part of the Roskilde site's QA organization, consisting of four departments – QMS, Technical Quality (TQ), Quality Control (QC) and In-process Control (IPC) – counting a total of 40 employees.
The Roskilde QA Organization has the responsibility for testing, design control and release of non-regulated and as well as regulated products (class 2a and class 1 IVDR products).
The QA team at our production site in Roskilde is part of a large global QA organization within the Laboratory Plastics Essentials Division of Thermo Fisher Scientific. So, you will participate in daily international meetings and conversations.
What will you do?
Your main responsibility will be supplier and audit management. A global team is responsible for the supplier audit program, and for our site in Roskilde, you will be responsible for, but not limited to:
• Lead, manage and implement standard work for supplier quality management activities in cooperation with sourcing and purchasing, and the global audit team
• Draft, review and approve Quality Agreements
• Approval, contracting and monitoring of quality performance of suppliers and third-party vendors (Contract Manufacturing Organizations)
• Internal audit program and performing internal audits and follow-up
• External audit program – participate and follow up on customer audits, and inspections from notified bodies and authorities (FDA)
Furthermore, your will be overall responsible for the general oversight of quality processes for the site as well as supporting the QMS Manager with Quality Management Review, Review Boards and KPIs. We are in the middle of an exciting process, optimizing quality processes for the Roskilde site, and harmonizing processes across sites.
You will participate in cross-functional improvement projects relating to our quality strategy and compliance program e.g. tasks:
• Provide general quality support to the organization (suppliers, complaints, audit findings, CAPA, NC, audit etc.)
• Optimize and write SOP's and implement processes on site including training
• Facilitate improvements within Quality and provide training in QMS and GMP to the site
• Promote continuous improvement within the department and provide support to other departments in improvement activities
Who we are looking for:
We are looking for proactive and driven team-player with a strong business acumen and a pragmatic approach to solving problems, and who thrives working in a global matrix organization with a dynamic environment.
Furthermore, we expect that you
• Have completed an education within health and natural sciences (Bsc, MSc)
• Have experience within Life Science, Medical Devices, In-vitro Diagnostics
• Have documented experience within supplier management and QMS processes
• Have an analytical mind-set and a great ability to learn new professional fields and business processes
• Have a great ability to structured and goal-oriented manner
• Are good at mapping flows and describing processes
• Has good communication skills, both in Danish and English
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon
With Thermo Fisher Scientic, it's not just a career. It's a chance to realise your best – professionally and personally.
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