Technical Quality Manager
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Roskilde
Title: Technical Quality Manager
Do you have a passion for technical troubleshooting, product and process design? Do you have experience with leading a team and driving continuous improvements in the Life Science Industry? If yes, then this position as Manager of Technical Quality may just be meant for you.
About QA
The Technical Quality (TQ) department is part or the QA/QC functional area consisting of 4 departments - Quality Management Systems (QMS), Technical Quality (TQ), Quality Control (QC) and In-process Control (IPC) – counting a total of 40 employees. QA 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) according to ISO13485 and 21CFR Part 820.
As manager of TQ you are reporting to the Site QA Head. QA in Nunc is part of a large global QA organization in the Laboratory Plastics Essentials (LPE) division of Thermo Fisher.
About the job
Your main responsibilities are to lead your team and ensure technical quality support to the Site including, but not limited to
Technical support to the site includes co-operation within QA and other departments, with the Engineering, Manufacturing and Maintenance areas in particular. In our matrix organization you will also report to and benefit from professional and technical support from a Global Sr. Design Engineer who is responsible for supporting all sites within LPE.
Your Education and personal Qualifications
Education within technical sciences (BSc, MSc). You have experience within Life Science, Medical Devices, and/or In-vitro Diagnostics. Experience with plastics and plastic molding processes is an extra plus. You have documented experience with leadership.
We expect the following personal skills:
Do you have a passion for technical troubleshooting, product and process design? Do you have experience with leading a team and driving continuous improvements in the Life Science Industry? If yes, then this position as Manager of Technical Quality may just be meant for you.
About QA
The Technical Quality (TQ) department is part or the QA/QC functional area consisting of 4 departments - Quality Management Systems (QMS), Technical Quality (TQ), Quality Control (QC) and In-process Control (IPC) – counting a total of 40 employees. QA 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) according to ISO13485 and 21CFR Part 820.
As manager of TQ you are reporting to the Site QA Head. QA in Nunc is part of a large global QA organization in the Laboratory Plastics Essentials (LPE) division of Thermo Fisher.
About the job
Your main responsibilities are to lead your team and ensure technical quality support to the Site including, but not limited to
- Providing direction and work structure according to strategy, goals and procedures (SOPs)
- Empowering employees by delegating responsibilities and providing feedback
- Coaching and mentoring incl. competency development planning
- Fostering a team spirit and work culture according to company values
- Transparent communication though team meeting, one-on-one meetings as well as external customer facing meetings
- Technical trouble shooting of non-conformities, complaints, audit findings etc.
- Review and approval of Change Orders and planned deviations
- Approval of technical specifications and drawings
- Approval of equipment qualification, process, software and sterility validation
- Approval of risk assessments and review of technical file/Device History File
- Participate in New Product Development projects as well as continuous improvement projects
Technical support to the site includes co-operation within QA and other departments, with the Engineering, Manufacturing and Maintenance areas in particular. In our matrix organization you will also report to and benefit from professional and technical support from a Global Sr. Design Engineer who is responsible for supporting all sites within LPE.
Your Education and personal Qualifications
Education within technical sciences (BSc, MSc). You have experience within Life Science, Medical Devices, and/or In-vitro Diagnostics. Experience with plastics and plastic molding processes is an extra plus. You have documented experience with leadership.
We expect the following personal skills:
- Self-directed, persistent and goal oriented
- Good organization skills to plan staff workload and prioritization of assignments
- Ability to motivate and retain trained and empowered employees
- Good business understanding and a pragmatic approach to problem solving
- Project management skills
- Strong analytical and problem-solving skills
- Data analysis and interpretation including proficiency in excel and statistical tools
- Ability and familiarity to navigate in a big global organization
- Good presentation and communication skills, verbal and written in both Danish and English
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Roskilde.
Jobbet er oprettet på vores service den 29.12.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Afdelingsleder
- Roskilde
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6. november 2024 | 11 |
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