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Technical Quality Engineer
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support, Engineer
Projektbeschreibung
TECHNICAL QUALITY ENGINEER
Our client, a top 20 medical device manufacturer, is currently undertaking a QA improvement drive for their Surgical Tools Division. They are looking for a Regulatory Affairs specialist to support them in resolving outstanding remediation items for their technical regulatory submission files. This position will lead large scope projects, of significant strategic importance to the business.
The scope of the Technical Quality Engineer is to develop quality standards for the organization's raw materials, in-process products, and finished products and design new, complex, or innovative measures, tests, sampling methods, and other procedures that ensure that these standards are met.
Role:
- Perform more complex quality analyses and inspections, for example data analysis, benchmark testing, localisation, and destructive/non-destructive analysis.
- Manage non conformities (related to incoming inspection, in process or final control), lead the Material Review Board for the final disposition, follow-up on related actions and manage the records.
- Manage the quality release through the DHR review and approval.
- Evaluate quality data and reports to identify and address recurring problems either with the quality of the product or the reliability of testing procedures. Support the Implementation of the organisation's manufacturing processes, systems, and technology and recommend changes that will improve the quality of the organisation's finished products.
- May include: assistance to Quality Manager on: educate, train, and monitor the performance of quality assurance inspectors and other staff to ensure that they understand and comply with established quality procedures and standards.
- Manages quality related issues: is technically competent to evaluate design control/product validation activities and data to ensure that design control/validation activities and data are appropriately implemented and utilised to support desired objections and conclusions.
- Provides audit methodology. Participate in internal or external audits
- May include: Coach and mentor less experienced engineers; check the quality of their work and help them resolve problems.
- Closely co-operates/interacts with the vendors and suppliers to optimize the flows and controls.
Requirements:
- Expertise in measuring techniques.
- Demonstrated ability to learn key products and process knowledge quickly.
- Strong understanding of Analytical Skills and Statistic methods.
- Quality management systems and methodologies.
- Understanding of rules and regulatory frames.
- Motivation and commitment to results.
- Driver of change, propose actively initiatives and innovative solutions
- Experience in medical device operations which enables first-hand knowledge of manufacturing, QC/QA, and regulatory and interface with R&D, Purchasing.
- Medical Device experience preferred
Our client, a top 20 medical device manufacturer, is currently undertaking a QA improvement drive for their Surgical Tools Division. They are looking for a Regulatory Affairs specialist to support them in resolving outstanding remediation items for their technical regulatory submission files. This position will lead large scope projects, of significant strategic importance to the business.
The scope of the Technical Quality Engineer is to develop quality standards for the organization's raw materials, in-process products, and finished products and design new, complex, or innovative measures, tests, sampling methods, and other procedures that ensure that these standards are met.
Role:
- Perform more complex quality analyses and inspections, for example data analysis, benchmark testing, localisation, and destructive/non-destructive analysis.
- Manage non conformities (related to incoming inspection, in process or final control), lead the Material Review Board for the final disposition, follow-up on related actions and manage the records.
- Manage the quality release through the DHR review and approval.
- Evaluate quality data and reports to identify and address recurring problems either with the quality of the product or the reliability of testing procedures. Support the Implementation of the organisation's manufacturing processes, systems, and technology and recommend changes that will improve the quality of the organisation's finished products.
- May include: assistance to Quality Manager on: educate, train, and monitor the performance of quality assurance inspectors and other staff to ensure that they understand and comply with established quality procedures and standards.
- Manages quality related issues: is technically competent to evaluate design control/product validation activities and data to ensure that design control/validation activities and data are appropriately implemented and utilised to support desired objections and conclusions.
- Provides audit methodology. Participate in internal or external audits
- May include: Coach and mentor less experienced engineers; check the quality of their work and help them resolve problems.
- Closely co-operates/interacts with the vendors and suppliers to optimize the flows and controls.
Requirements:
- Expertise in measuring techniques.
- Demonstrated ability to learn key products and process knowledge quickly.
- Strong understanding of Analytical Skills and Statistic methods.
- Quality management systems and methodologies.
- Understanding of rules and regulatory frames.
- Motivation and commitment to results.
- Driver of change, propose actively initiatives and innovative solutions
- Experience in medical device operations which enables first-hand knowledge of manufacturing, QC/QA, and regulatory and interface with R&D, Purchasing.
- Medical Device experience preferred
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges