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Senior New Product Introduction Quality Engineer

Posted on Oct 9, 2019 by Sentinel IT LLP

Not Specified, Switzerland
Research
Immediate Start
€575 - €625 Daily
Contract/Project

Senior New Product Introduction Quality Engineer

Leading global pharma client, require a Quality Engineer for new product introduction in their medical devices division. This is a long-term contract based in Neuchatel.

Supporting the New Product Introduction (NPI) Quality Group for the Access and Advances Energy (A&AE) Platform, the qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multi-discipline team, must be self-motivated, and have excellent written and verbal communication skills.

The Mitek NPI teams are international teams based in Raynham, MA which require strong team work and communication skills from all team members.

Working in Neuchatel supporting the Mitek NPI team, this individual's major responsibilities will be as follows (but not limited to):

NPI team member focuses on risk management for the Mitek A&AE platform
Direct contributor on international NPI team to develop product in Mitek Design Control system and transfer the product to manufacturing
Support and lead design control activities for NPI projects
Champion supplier risk management activities for the A&AE NPI team
Establish and review NPI related protocols, reports, procedures, specifications and systems to provide QSR/ISO compliance consistent with the development of medical device products
Conduct and lead process validation activities
Conduct and lead process/design failure mode effects and analysis
Develop inspection methodology and acceptance criteria for inspection sample plans
Apply statistical methods to evaluate test data and processes. Perform test method validation and Gage R&R studies for new inspection techniques and test equipment
Conduct internal audits of the quality system to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements
Perform product/process specific supplier assessments to support NPI project teams
Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Nonconforming Materials, Risk Management, etc.
Provides leadership in the understanding of medical device regulations to other disciplines. This candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
Support Base Business and Production Improvement Initiatives

Qualifications

A minimum BS degree in an engineering or technical discipline is preferred with 5 years of related experience in required. A Master's degree is a plus
Fluent in English and French is required
Knowledge and application of FDA QSR, ISO 13485:2003, and ISO 14971:2007 is preferred
Strong quality engineering skills with a proven track record in design verification/validation process verification/validation, and design/process failure modes and effects analyses is strongly preferred
Blueprint literacy including GD&T preferred
Previous experience in a medical device or a healthcare discipline is highly preferred
Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations
Knowledge of MiniTab is a plus
This candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals
Proficiency with the Microsoft Office Suite is preferred
This position will require up to 20% international travel

Please apply now for more information!


Reference: 770265255

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