Senior Quality Engineer

The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient / user safety, customer satisfaction, and organizational success.

RESPONSIBILITIES

Lead and / or support on-time completion of Design Control deliverables

Support the establishment of objective, measurable, and verifiable product requirements

Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities

Lead Risk Management activities from product concept through commercialization

Support test method development and lead test method validation activities

Support manufacturing process development & qualification for new product and design changes

Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications

Support biocompatibility and sterilization qualifications

Support audits and quality system improvement activities

Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.

Comply with Client, U.S. FDA, EUMDR and other requirements, as applicable.

Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Basic Qualifications :

Bachelors degree in Engineering or Technical Field.

Minimum of 5 years of experience in R&D, Process / Manufacturing Engineering, and / or Quality with at least 2 years supporting product development.

Experience in medical devices and associated regulations / standards.

Experience in test method development and validation

Experience in preparing risk assessments, FMEA and other risk documents.

Preferred Qualifications :

Advanced Degree in Engineering / Technical Field

Experience in active implantable medical devices.

Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).

Working knowledge of statistics and its application to verification and validation?

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority / Gender / Disability / Religion / LGBTQI / Age / Veterans.

If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on nirajk@mindlance.com

Regards

Niraj kumar