Quality Engineer- Medical Device

The Quality Engineer is responsible for overseeing the continual improvement of medical devices and the design and manufacturing of new devices. This role involves developing QA procedures, assessing regulatory standards, leading design control projects, and ensuring product quality through various analyses and audits.

Client Details

The client is in the business of life science, specifically focused on the manufacturing of medical devices and disposables. They collaborate with medical personnel and are involved in ensuring quality and regulatory compliance within the medical device industry.

Description

• Develop, document, and implement QA procedures.

• Interpret and assess conformity to regulatory standards.

• Provide analytical investigations and develop root cause for non-conformances.

• Lead and participate in design control projects for new and changing medical devices.

• Design and specify gauging and test equipment for quality assurance.

• Write protocols, analyze data, and generate summary reports for verifications and validations.

Profile

A successful candidate for the Quality Engineer position:

• Has a BS or MS in Engineering or with 5-7 years of experience in the manufacture of medical devices.

• Exhibits strong verbal and written communication skills, is organized, and has excellent record-keeping and follow-up skills.

• Is a team player with strong communication, interpersonal, and presentation skills, and demonstrates the ability to work independently and take initiative.

Job Offer

Here's what's on offer for the candidate:

• The opportunity to work as a Quality Engineer, contributing to the continual improvement of medical devices and the design and manufacturing of new devices.

• The chance to work under the guidance/direction of the Director of QA/RA.

• The opportunity to collaborate in a team environment with the Quality Department and J-Pac Medical personnel.

• Experience in a role that involves a variety of responsibilities, including developing QA procedures, ensuring regulatory compliance, conducting investigations, designing test equipment, and participating in design control projects.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Salary : $95,000 - $115,000