Quality Engineers, Validation Consultant (ENG&FR - a must)
Posted on Oct 4, 2019 by Harvey Nash IT Recruitment Switzerland
For our client in Neuchâtel we are looking for Quality Engineers, Validation Consultant for 14-month contract.
Job title: Quality Engineers, Validation Consultant
Duration: 01/11/2019 to 31/12/2020
Responsibilities for Senior New Product Introduction Quality Engineer:
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 DePuy 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
. 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.
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management for internal guidelines.
For further details please contact: