Design Quality Engineer


Premium Job From Michael Bailey Associates

Recruiter

Michael Bailey Associates

Listed on

7th January 2020

Location

Switzerland

Salary/Rate

Negotiable

Salary Notes

Negotiable

Type

Contract

Start Date

03/02/2020

This job has now expired please search on the home page to find live IT Jobs.

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

OTHER REQUIREMENTS:

* 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.Michael Bailey International is acting as an Employment Business in relation to this vacancy.

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