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Quality Engineer
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineering, Support, Plm, Engineer
Projektbeschreibung
Quality Engineer
You are an outstanding Quality Engineer with experience in the area of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
Project:
By May 26th 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR)
Overview:
This role supports manufacturing operations in the areas of process development, tool design, machine programming & layout, machinery & equipment, continuous improvement and other duties associated with engineering support of production.
Duties & Responsibilities:
- Support process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
- Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- Ensure the development of a comprehensive risk management plan for the product and process
- Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
- Assists in the development of manufacturing and inspection procedures.
- Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Support Base Business and Production Improvement Initiatives
- Additional duties as assigned.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Requirements:
- Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
- 4-6 years of experience in quality engineering is required.
- Experience with ISO 9000, ISO 13485 and GMP
- Experience in Design and Process validation
- Quality Tools Knowledge
- Previous experience working in a regulated industry, such as Medical Device is preferred.
- Six Sigma or Lean Sigma certification or 4 years of experience preferred.
- Experience with packaging, Laser, and CNC processes and equipment, preferred
- Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
- Strong knowledge and skills in PLM system, Agile PLM, SAP, Windchill, Adaptive will enhance candidacy
- Must be highly organized, creative, articulate and analytical
- Fluent in English
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.
You are an outstanding Quality Engineer with experience in the area of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
Project:
By May 26th 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR)
Overview:
This role supports manufacturing operations in the areas of process development, tool design, machine programming & layout, machinery & equipment, continuous improvement and other duties associated with engineering support of production.
Duties & Responsibilities:
- Support process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
- Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- Ensure the development of a comprehensive risk management plan for the product and process
- Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
- Assists in the development of manufacturing and inspection procedures.
- Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Support Base Business and Production Improvement Initiatives
- Additional duties as assigned.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Requirements:
- Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
- 4-6 years of experience in quality engineering is required.
- Experience with ISO 9000, ISO 13485 and GMP
- Experience in Design and Process validation
- Quality Tools Knowledge
- Previous experience working in a regulated industry, such as Medical Device is preferred.
- Six Sigma or Lean Sigma certification or 4 years of experience preferred.
- Experience with packaging, Laser, and CNC processes and equipment, preferred
- Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
- Strong knowledge and skills in PLM system, Agile PLM, SAP, Windchill, Adaptive will enhance candidacy
- Must be highly organized, creative, articulate and analytical
- Fluent in English
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges