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Business Project Manager
Eingestellt von Brainbridge
Gesuchte Skills: Engineering, Support
Projektbeschreibung
Location: Beerse
Job type: Project Management and Business Consulting
Description:
Quality and compliance lead for device and device component suppliers of combination products, ensuring quality standards are achieved and oversee proactive quality improvement implementations.
This oversight includes ensuring compliance with relevant regulatory health authority requirements and providing leadership for increasing supplier reliability and quality through applying process excellence tools and continuous improvement methodologies. Lead effective collaboration between R&D, Operations, Procurement, Regulatory Affairs and other disciplines. Functions and activities include quality assurance review and approval functions, compliance audit activities, proactive quality improvement plans for suppliers of combination product devices and device components.
Essential Functions:
• Support quality and compliance activities related to suppliers for combination product devices and device components.
• Manage quality activities with suppliers including quality agreements, deviations, investigations, change control, and risk assessments.
• Report on supplier performance and issues via metrics and reports.
• Assess current quality systems and recommending improvements in order to enhance quality, to promote continuous improvement and to promote pro-active quality culture.
• Frequent interaction with Procurement, R&D, Quality Assurance functions, internal JSC sites and other stakeholders.
Surveillance on the quality and compliance status for all suppliers sourcing combination product devices or components to the Supply Chain for the manufacture of combination products, including supplier qualification and monitoring, escalations, deviations and complaints handling
Manage improvement projects related device or device component suppliers
Technical skills:
• A minimum of 3 years' experience at a medical device or pharmaceutical manufacturing company is required.
• A minimum of a Bachelor's Degree is required in Engineering, Life Science, or related discipline (Master's degree is preferred).
• FDA 21 CFR Part 820 and/or ISO 13485 knowledge is required
• Project Management experience required
• Strong communication, teamwork, problem solving and decision-making skills are required.
Personal skills:
1. Coordination and execution of ESIQ SQ activities related to supplier projects
2. Performing of supplier assessments
3. Setting up communication with suppliers related to required documentation, assessments,…
4. Implementation of Quality Agreements between the company and suppliers
5. Participation in new supplier related improvement projects
Job type: Project Management and Business Consulting
Description:
Quality and compliance lead for device and device component suppliers of combination products, ensuring quality standards are achieved and oversee proactive quality improvement implementations.
This oversight includes ensuring compliance with relevant regulatory health authority requirements and providing leadership for increasing supplier reliability and quality through applying process excellence tools and continuous improvement methodologies. Lead effective collaboration between R&D, Operations, Procurement, Regulatory Affairs and other disciplines. Functions and activities include quality assurance review and approval functions, compliance audit activities, proactive quality improvement plans for suppliers of combination product devices and device components.
Essential Functions:
• Support quality and compliance activities related to suppliers for combination product devices and device components.
• Manage quality activities with suppliers including quality agreements, deviations, investigations, change control, and risk assessments.
• Report on supplier performance and issues via metrics and reports.
• Assess current quality systems and recommending improvements in order to enhance quality, to promote continuous improvement and to promote pro-active quality culture.
• Frequent interaction with Procurement, R&D, Quality Assurance functions, internal JSC sites and other stakeholders.
Surveillance on the quality and compliance status for all suppliers sourcing combination product devices or components to the Supply Chain for the manufacture of combination products, including supplier qualification and monitoring, escalations, deviations and complaints handling
Manage improvement projects related device or device component suppliers
Technical skills:
• A minimum of 3 years' experience at a medical device or pharmaceutical manufacturing company is required.
• A minimum of a Bachelor's Degree is required in Engineering, Life Science, or related discipline (Master's degree is preferred).
• FDA 21 CFR Part 820 and/or ISO 13485 knowledge is required
• Project Management experience required
• Strong communication, teamwork, problem solving and decision-making skills are required.
Personal skills:
1. Coordination and execution of ESIQ SQ activities related to supplier projects
2. Performing of supplier assessments
3. Setting up communication with suppliers related to required documentation, assessments,…
4. Implementation of Quality Agreements between the company and suppliers
5. Participation in new supplier related improvement projects
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges