Job Description

Location:

Anasco, Puerto Rico

Salary:

Depends on experience

Role Purpose:

Perform Device History Record (DHR) reviews and audits upon completion to ensure compliance with company and regulatory guidelines. Manage documentation and quality records to meet operational and quality system standards.

Essential Duties and Responsibilities:

Review DHR and work order documentation for accuracy and completeness to determine product release readiness. Perform product releases in ERP systems (e.g., JDE) and generate reports to track release status. Communicate release information to the appropriate deviation or quality teams. Scan, verify, and upload documents into Product Data Management systems (e.g., Work Orders, Protocols, Reports). Distribute controlled documents and procedures to relevant personnel. Maintain change control records and documentation tracking. Process Labeling Enterprise Change Request (ECR) packages in accordance with company procedures. Support and train employees in the use of electronic documentation systems (e.g., PLM, TeamCenter, JDE).

Marginal Duties:

Perform occasional administrative tasks such as photocopying, document delivery, or other related support as needed.

Qualifications:

Education:

High School Diploma or equivalent required.

Experience:

Minimum 4 years of related experience in

Quality functions or DHR auditing

within the

medical device industry

.

Required Skills and Competencies:

Excellent computer skills, including proficiency with MS Office Suite. Experience with

ERP systems

(e.g., JDE) and

electronic documentation systems

(PLM, TeamCenter). Strong written and verbal communication skills in English. Broad knowledge of documentation systems and labeling processes. Strong attention to detail and accuracy. Ability to work independently and within a team environment. Knowledge of

GMP

,

GDP

,

EHS

, and

Quality System

regulations applicable to medical device manufacturing. Ability to manage multiple documentation processes under tight deadlines.

Environmental, Health & Safety (EHS) Responsibilities:

Adhere to all Environmental, Health, and Safety (EHS) regulations and company procedures. Ensure proper handling, storage, and disposal of waste according to local and federal laws. Take appropriate measures to prevent workplace injuries and environmental pollution.

Additional Information:

Full-time position based in

Anasco, Puerto Rico

. Salary is

commensurate with experience and qualifications

.
Job Types: Full-time, Contract

Pay: $20.00 - $21.00 per hour

Expected hours: 40 per week

Work Location: In person