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Design Quality Engineer
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Design, Engineering, Engineer
Projektbeschreibung
For our client in OBERDORF (SWITZERLAND) we are looking for a DESIGN QUALITY ENGINEER for a 1 YEAR contract.
LOCATION: OBERDORF, Switzerland
DURATION: 07/01/2019 to 31/12/2019
WORKLOAD: 100%
PROJECT DESCRIPTION:
. By May 26th 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR)
. Manage the Key MDR program from concept through execution.
. Ensure full alignment at all sector and enterprise level to Global Plan strategy.
. Liaise with all key stakeholders when formulating and communicating the Project Plans.
. Ensure continually deployment of the MDR Plan through consistent excellence in project management.
POSITION DUTIES & RESPONSIBILITIES:
* Design Quality team member focused on life cycle management activities.
. Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement.
. Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies.
. Conduct and lead design verification and validation activities.
. Conduct and lead design/process failure mode effects and analysis.
. Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
. Provide leadership in the understanding of medical device regulations to other disciplines.
. Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
. Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
. Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.
. Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
. Additional duties as assigned.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
. A minimum of a BACHELOR'S DEGREE in ENGINEERING or RELATED technical or scientific discipline with a minimum of 7+ YEARS OF EXPERIENCE in related field is required.
. Proven exceptional written and oral presentation skills
. Working knowledge of DESIGN CONTROLS, GMPS, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required.
. Previous QUALITY ENGINEERING experience is preferred.
. Experience in an MEDICAL DEVICE regulated environment
. Strong knowledge and skills in MS OFFICE
. Excellent problem solving, decision-making, and root cause analysis skills are required.
. Interpersonal skills that foster conflict resolution are required.
. Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred.
. Ability to multi-task independently with minimal supervision
Working knowledge of material science and mechanical product knowledge is preferred.
. Development and manufacturing experience is preferred.
. Fluency in ENGLISH is required, good knowledge of GERMAN would be a strong asset.
LOCATION: OBERDORF, Switzerland
DURATION: 07/01/2019 to 31/12/2019
WORKLOAD: 100%
PROJECT DESCRIPTION:
. By May 26th 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR)
. Manage the Key MDR program from concept through execution.
. Ensure full alignment at all sector and enterprise level to Global Plan strategy.
. Liaise with all key stakeholders when formulating and communicating the Project Plans.
. Ensure continually deployment of the MDR Plan through consistent excellence in project management.
POSITION DUTIES & RESPONSIBILITIES:
* Design Quality team member focused on life cycle management activities.
. Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement.
. Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies.
. Conduct and lead design verification and validation activities.
. Conduct and lead design/process failure mode effects and analysis.
. Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
. Provide leadership in the understanding of medical device regulations to other disciplines.
. Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
. Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
. Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.
. Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
. Additional duties as assigned.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
. A minimum of a BACHELOR'S DEGREE in ENGINEERING or RELATED technical or scientific discipline with a minimum of 7+ YEARS OF EXPERIENCE in related field is required.
. Proven exceptional written and oral presentation skills
. Working knowledge of DESIGN CONTROLS, GMPS, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required.
. Previous QUALITY ENGINEERING experience is preferred.
. Experience in an MEDICAL DEVICE regulated environment
. Strong knowledge and skills in MS OFFICE
. Excellent problem solving, decision-making, and root cause analysis skills are required.
. Interpersonal skills that foster conflict resolution are required.
. Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred.
. Ability to multi-task independently with minimal supervision
Working knowledge of material science and mechanical product knowledge is preferred.
. Development and manufacturing experience is preferred.
. Fluency in ENGLISH is required, good knowledge of GERMAN would be a strong asset.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik