Job Description

Job description

Job Title: Quality Specialist - Change Control System

Salary: $60K-$70K

Location: Pompano

Job Overview:

We are seeking a highly organized and detail-oriented Quality Specialist to manage the Change Control System. This role involves overseeing the documentation, review, and approval of change requests, analyzing risk assessments, and ensuring compliance with regulatory standards. You will work closely with cross-functional teams to implement changes, update documents, and coordinate training when necessary.

Key Responsibilities:

• Manage the change control process, ensuring all change requests are documented, reviewed, and approved.
• Analyze risk assessments for proposed changes and identify potential impacts.
• Coordinate updates to documents and training as needed.
• Maintain accurate records throughout the change control process.
• Collaborate with teams across the organization to ensure smooth change implementation.
• Support FDA inspections and external audits by providing required documentation.
• Continuously review and improve the change control process to maintain quality standards.
• Ensure compliance with regulatory standards and internal policies.

Qualifications:

• Bachelor’s degree in a relevant field or equivalent work experience.
• Minimum of 3 years of experience in change control, document management, or training program management in a regulated environment, preferably within the medical device industry.
• Strong organizational skills, attention to detail, and the ability to multitask.
• Proficient in Microsoft Word, Excel, and Outlook.
• Experience in analyzing risk assessments and ensuring regulatory compliance.

Job Types: Full-time, Permanent

Pay: $60,000.00 - $70,000.00 per year

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