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Design Quality Engineer
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Design, Engineering, Engineer
Projektbeschreibung
Design Quality Engineer
You are an expert in Design Controls with working experience in a Medical Device regulated environment? 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!
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.
Your Profile:
- A minimum of a Bachelor's degree in Engineering or related technical or scientific discipline with a minimum of 5 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.
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 expert in Design Controls with working experience in a Medical Device regulated environment? 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!
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.
Your Profile:
- A minimum of a Bachelor's degree in Engineering or related technical or scientific discipline with a minimum of 5 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.
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:
Medien/Design, Ingenieurwesen/Technik