Quality Assurance Associate

Position: Quality Compliance Associate – MedTech

Location: North New Jersey. Onsite.

I am currently working with an innovative MedTech company specializing in regenerative medicine and tissue engineering to find a talented Quality Compliance Associate. This is a fantastic opportunity for someone with a strong background in quality management and regulatory compliance within the medical device industry.

Key Responsibilities:

• Manage non-conformities and CAPAs (Corrective Actions/Preventive Actions) along with change management forms.
• Oversee distributor and supplier qualifications to ensure consistent quality.
• Maintain and support the QMS to stay compliant with FDA, ISO 13485, and MDSAP standards.
• Evaluate the performance of the QMS and implement necessary improvements.
• Assist the R&D team with design control records.
• Supervise and manage internal audit processes.
• Coordinate and ensure quality functions across departments meet industry standards.
• Perform additional duties related to the QMS as needed.

Qualifications:

• Bachelor’s degree in Biology or a related field.
• At least 3 years of experience in the medical device or pharmaceutical industry.
• Strong organizational, communication, and interpersonal skills.
• Solid knowledge of FDA, ISO 13485, and other global quality standards.

Why Join This Company?

• Work with a forward-thinking MedTech company making strides in regenerative medicine and tissue engineering.
• A dynamic, fast-paced environment with excellent career growth potential.

If you are interested or know someone who might be, please contact me at

o.archer@x4lifesciences.com.