Job Description

Job Summary

Perform Document Control and Quality Assurance activities related to document management and compliance audit activities. This is a hands-on onsite role supporting quality systems, controlled documentation, engineering change processes, and RMA activities.

Key Responsibilities

Coordinate document control activities including distribution, auditing, tracking, and reporting of controlled documents.
Manage archival activities for controlled documents and validation files.
Implement and administer the electronic document management system.
Manage the ECR/ECO process and facilitate weekly review meetings.
Support Quality Management System audits and compliance activities.
Review specification changes from customers and agencies.
Coordinate RMA activities and maintain reporting metrics.

Education & Experience

High School Diploma or equivalent.
Bachelor’s degree in a technical field preferred.
1-3 years of manufacturing experience.
Experience with engineering/manufacturing documentation and documentation practices.
Knowledge of ISO 13485, ISO 9001, FDA 21 CFR Part 820, and AS9100 is a plus.

Must-Have Requirements

High School Diploma or equivalent.
1-3 years of experience in a manufacturing environment.
Experience working with engineering and manufacturing documentation.
Knowledge of document control procedures and good documentation practices.
Strong Microsoft Excel and Microsoft Office proficiency.
Excellent organizational skills and attention to detail.
Ability to manage multiple priorities and work independently.
Strong written and verbal communication skills.

Preferred Qualifications

Bachelor's Degree in a technical field.
Experience with electronic document management systems (EDMS).
Knowledge of ISO 13485, ISO 9001, FDA 21 CFR Part 820, and/or AS9100 standards.
Experience managing Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
Experience supporting quality audits and compliance activities.
Background in electronics, aerospace, medical device, or other regulated manufacturing environments.
Veterans are encouraged to apply.

Skills & Abilities

· Strong attention to detail and organizational skills.

· Ability to manage multiple priorities in a fast-paced environment.

· Strong communication and collaboration skills.

· Microsoft Excel and Office proficiency.

Sincerus Solutions

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