Job Summary

Quality/V&V Engineer

  • Location:
    Mansfield, Massachusetts
  • Job reference:
    US_EN_3_983629_326927
  • Category:
    Quality Assurance
  • Contract Type:
    Contract/Temporary

A Quality/V&V Engineer job in Mansfield, MA is available through Modis. You must have experience in medical device product development / process and product validation to be considered for this position. In this role, you will be responsible for supporting design changes and improvements on a range of Neurosurgical Medical Devices.

Quality/V&V Engineer job responsibilities include:
• Support improvements of existing products as part of the design change process, support supply chain concerns as well as design related aspects of product and process transfers between manufacturing sites.
• Execute base business design change projects to ensure the highest levels of product quality to the end customer.
• Lead and/or support design changes and improvements to Medical devices in close collaboration with R&D and external partners
Lead and/or support risk analysis activities.
• Apply statistical methods and process/design excellence tools to establish validation and test plans as well as evaluate test data and processes.


QUALIFICATIONS:
• Bachelor’s degree (or equivalent) in Engineering or related technical/scientific field.
• Four or more year's of related experience
• Knowledge of Quality Engineering/Scientific methods and techniques.

• Experience managing projects and demonstrating leadership abilities.


If you are interested in this Quality/V&V Engineer job in Mansfield, MA then please click APPLY NOW. If you have questions about the position or would like more information please contact Gina Jackson at Gina.Jackson@modis.com.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

The Senior Life Cycle Management (LCM) Quality Engineer will work within the Quality organization to support design changes and improvements on our range of Neurosurgical Medical Devices.

Working within the LCM Design Quality team, you should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills. The position will support improvements of existing products as part of the design change process, support supply chain concerns as well as design related aspects of product and process transfers between manufacturing sites. This position will have responsibility for executing base business design change projects to ensure the highest levels of product quality to the end customer. Being able to independently plan and conduct projects and/or assignments with technical responsibilities or strategic inputs with moderately detailed instructions from Leaders and Stakeholders is a must-have.



Lead and/or support design changes and improvements to Medical devices in close collaboration with R&D and external partners
Lead and/or support risk analysis activities. Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode effects analysis).
Apply statistical methods and process/design excellence tools to establish validation and test plans as well as evaluate test data and processes.
Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control
Conducts, and supports the development of test methods, process validation / verification, and product validation / verification.
Support transfer to manufacturing activities both in product development and base business
Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions.
Develop inspection methodology and acceptance criteria for sampling plans
Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
Support supply chain issue resolution / product investigations for our base business products
Fulfill design change control requirements in accordance with company procedures, FDA and ISO guidelines
Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
Demonstrate project management and leadership abilities

Job requirements

Bachelor’s degree (or equivalent) in Engineering or related technical/scientific field with a minimum of 4 years of related experience.
Experience in medical device product development / process and product validation
Knowledge of Quality Engineering/Scientific methods and techniques.
Experience managing projects and demonstrating leadership abilities.
Strong analytical and statistical skills
Six Sigma certification preferred
Knowledge of Standards and regulations: ISO 9000, ISO 13485, ISO 14971, and CFR 820 is preferred


Apply Below!

Note: Required fields marked with an asterisk (*).

*
Greeting



*
*
*
*
*
*
Primary Number
*
*
Preferences
[Ctrl (Cmd Mac) + Click] to select multiple industries
Upload your resume
*
Terms of Use
*

Or

Upload your resume using

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
EEO is the Law (poster) | EEO is the Law (poster supplement) | Reaffirmation of Affirmative Action Policy Statement