Quality Assurance Assistant

BASIC FUNCTION

Under broad oversight and in compliance with Company policies and procedures, the Quality Assurance Assistant shall support the creation, implementation, and maintenance of policies procedures and documentation required to sustain and continuously improve the company’s Quality Management System.

MAJOR RESPONSIBILITIES

1. Assist with overall Quality Management System responsibilities to stay compliant with internal and external policies and procedures.

2. Assisting with Employee training and documentation requirements.

3. Support Internal / External document control and revision management.

4. Maintain company Contact Materials List and associated safety data sheets – add/update as required.

5. Support Supplier management activities including updating supplier documentation files, supplier score cards and Nonconformance and Corrective Actions.

6. Perform some technical and procedure writing to update documents including SOP and Work Instructions.

7. Completion of miscellaneous Customer quality related requests including providing compliance evidence for regulatory requirements and special projects.

8. Assisting with documenting and follow up from internal and external quality audits.

9. Perform basic contract and purchase order review.

10. Navigate and utilize internal systems to perform daily tasks including Visual Manufacturing and Visual Quality.

11. Will support other QMS duties as assigned.

JOB REQUIREMENTS

Education:

High School diploma or equivalent. College degree or Trade School certificate a plus.

Experience & Expertise:

• Minimum of three (3) years experience working in a similar Quality related position.

• Experience working in a highly regulated manufacturing industry a must. Prior exposure to ISO 13485 Device industry/working in compliance to ISO 13485 a plus.

• Understanding of good manufacturing and documentation practices.

• Strong personal and organizational skills.

• Proven record of success working in a fast-paced, high pressure, deadline-driven work environment.

• Proficiency with various software programs; including MS Office Suite (Word, Excel, PowerPoint).

Physical Demands:

• Required to stand for long periods of time.

• May involve some repetitive motions.

• Must be able to lift up to 25 pounds.

• May also engage in frequent bending, stooping, squatting, pushing and pulling.

Job Type: Full-time

Pay: $17.00 - $22.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience:

• Manufacturing Quality Related: 3 years (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: In person