What are the responsibilities and job description for the Quality Engineer II position at DivIHN Integration Inc?
Job Description
Job Description
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists :
Neha at 224 507 1279
Muskan at 224 369 4238
Title : Quality Engineer II
Location : Kennebunk, ME
Duration : 9 Months
Job Description : Must haves :
- Proficiency in Microsoft Office and Excel
- Ability to follow written procedures
- Detail oriented
- Ability to work autonomously
- This position is responsible for the development, maintenance, and management of Medical Device Files (MDFs) in accordance with ISO 13485 standards. This position will also be responsible for performing change controls, creating, and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System.
Description of work :
Developing, reviewing, maintaining, and updating medical device files in accordance with ISO 13485.
Coordinating across functions (development, operations, engineering, and quality) to ensure that all necessary documentation is collected and properly recorded.
Drive resolution on any non-compliance issues identified during creation of MDFs.
Initiates change controls and document change requests to update procedures and processes.
Supports or leads continuous improvement initiatives for quality management system processes.
Other duties as required.
Minimum Qualifications :
Associate or bachelor's degree in life sciences, engineering, or a related field. 3 years of experience in manufacturing environment is preferred.
Skills / Experience :
Comprehensive knowledge of ISO 13485 and other relevant regulations and standards.
Previous experience in the creation and management of Medical Device Files.
Strong attention to detail and high levels of accuracy.
Excellent documentation and record-keeping abilities.
Strong communication and interpersonal skills.
Ability to work cross-functionally and lead teams.
Proficient in the use of document management systems.
Experience as Internal auditor is preferred.
Project management skills preferred.
About us :
DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
