ISO 13485 QA Specialist II - QMS & Audits

Technipaq, Inc.; Crystal Lake (IL); On-site; USD 50,000 - 80,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid sick time

Paid vacation time

401(k) with company match

Paid holidays

Job summary

Technipaq, Inc. is seeking a Quality Specialist II to join the Quality team to support the health and compliance of the QMS in line with ISO 13485.

The role focuses on maintaining the QMS, including document and record control, change management, and training processes, with responsibilities for electronic QMS systems under the Quality Director. The position requires 2–4 years of QA administrative support in ISO manufacturing, with preferred Associate or bachelor's degree.

Qualifications

• 2–4 years' administrative support within a QA capacity in an ISO-certified manufacturing environment.
• Associate or bachelor's degree preferred.
• Must be at least 18 years old and pass pre-employment tests.

Responsibilities

• Maintain and support the Quality Management System (QMS) in alignment with ISO 13485.
• Support document and record control, change management, and training processes.
• Administer electronic systems for QMS management and maintenance.

Skills

Strong organizational skills

Communication skills

Education

Associate or bachelor's degree preferred

Tools

MS Office (Word, Excel)

Job description

Technipaq, Inc. is seeking a Quality Specialist II to join the Quality team to support the health and compliance of the QMS in line with ISO 13485.

The role focuses on maintaining the QMS, including document and record control, change management, and training processes, with responsibilities for electronic QMS systems under the Quality Director. The position requires 2–4 years of QA administrative support in ISO manufacturing, with preferred Associate or bachelor's degree.