Quality Engineer Specialist - Medical Device - Needham MA - JN-112021-4529953

Job Description
Summary
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About Our Client

Our client is a globally recognized surigcal equipment manufacturer. Breaking into the United States, their Needham location is the HQ for all things Sinus. Work with complex faux-tissue emulators to help heal sinus surgery.

Job Description

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.

Description

The Quality Engineer Specialist will...

Assist with the management of Quality Management System (QMS) with Quality Manager
Assist with establishing and maintaining quality policies and procedures and records management (e.g. Quality Policy Manual, document control, change control, quality records, corrective & preventive actions etc).
Assist in ensuring compliance with policies and procedures
Maintain customer complaint system to ensure complaints are investigated and resolved in a timely manner
Assist in providing quality system performance reports to management
Assist in conducting meetings to review status of key QMS indicators and performance, issues periodic reports to management

The Successful Applicant

The Quality Engineer Specialist should have...

Bachelor's Degree in a life science area or engineering degree
1-3 years Quality experience in the Medical Device industry (21 CFR 820/ISO 13485) OR relevant internship experience
Ability to operate independently in a small company where day-to-day activities and priorities can shift rapidly
Must have analytical experience