Quality Assurance Associate

MUST have !SO 13485 experience!

Hybrid model, 2-3 days onsite/week!

Description:

• To manage daily activities related to the warehousing system including release of the products
• To be in frequent contact with the 3PL warehouse for any quality activities
• Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD) and ISO standards. Will provide GMP and ISO 13485 compliance support

as necessary.

• Monitor and track quality system deliverables to completion including NC/CAPA actions, internal audit findings, supplier audits, and actions from management

reviews and data reviews.

• Assist with change control program management, maintain change control log, track activities, maintain documents, and prepare closures. Track quality reports

to completion.

• Manage supplier documentation for production, release, and development activities.
• Maintain and organize QA files for complaints, supplier management, and product release.
• Publish monthly quality report and KPI trends
• Revise SOPs/INSs, prepare flow charts and other quality documentation.
• Identify compliance weaknesses and ensure the implementation of workable solutions.
• Other related duties may also be required as part of this role.

Additional Skills & Qualifications:

AA or equivalent with a minimum 2 years of experience in quality (document control, audit, CAPA)

• Knowledge of FDA regulatory requirements, MUST have ISO 13485 experience
• Ability to work independently.
• Ability to work in an ambiguous, face paced environment.
• Excellent communication skills (interpersonal, written, verbal, listening).
• Excellent time management skills (timelines, schedules, task prioritization).
• Broad knowledge of medical terminology and industry.
• Attention to detail and accuracy.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.