Job Description
Job Description
Overview
Come join us and grow your career with CTG! CTG has worked with this international, Fortune 500 end-client for over 15 years! Apply with CTG for this exciting opportunity!
CTG's premier client has a contract assignment for a Quality Engineer II.
Type : Contract
Job Title : Quality Engineer II
Location : Kennebunk, ME
candidates must be able to commute and work onsite in Kennebunk, ME
Pay Rate : up to $44.70 per hour
Work Hours : M-F, 8am – 4 : 30pm
Education : Associate or Bachelor’s degree in life sciences, engineering, or a related field.
A successful candidate in this position will possess strong soft skills as well as :
- Attention to detail
- Excellent written and verbal communication skills
- Ability to work independently and manage multiple priorities
- Strong problem-solving and analytical skills
Description :
The Quality Engineer II will be responsible for the development, maintenance, and management of Medical Device Files (MDFs) in compliance with ISO 13485 standards. This includes performing change controls, creating and updating quality management procedures, managing records, and supporting internal audits to ensure compliance with the Quality Management System.
Key Responsibilities :
Develop, review, maintain, and update medical device files in accordance with ISO 13485 standards.Collaborate across functions (development, operations, engineering, and quality) to ensure all necessary documentation is gathered and properly recorded.Address non-compliance issues identified during the creation of MDFs and work toward resolutions.Initiate change controls and document change requests to update quality management procedures and processes.Lead or support continuous improvement initiatives for quality management system processes.Conduct internal audits to ensure adherence to the Quality Management System.Other duties as required.Requirements :
3 years of experience in a manufacturing environment, preferably with medical devices.Proficiency in Microsoft Office and Excel, with the ability to create detailed reports and manage data.Ability to follow written procedures and maintain high levels of accuracy in documentation and record-keeping.Detail-oriented with a focus on quality and accuracy.Strong communication and interpersonal skills, with the ability to work cross-functionally with diverse teams.Ability to work autonomously, managing multiple priorities and tasks effectively.Experience working with ISO 13485 and other related regulations and standards.Proven experience in the creation and management of Medical Device Files.Internal auditing experience is preferred.Project management skills are preferred.Additional Information :
No third-party resumes will be accepted.Drug testing and / or other employment-related inquiries may be conducted.CTG will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third-party vendors).CTG is an Equal Employment Opportunity employer.CTG is an E-Verify Company.To be considered for this opportunity, please apply directly through our website by clicking the link below or email your Word version resume and salary expectations to Laura Dominguez at Laura.Dominguez@ctg.com .
Salary : $45
