QA Contractor (1.5 Days)

Pale Blue Dot® Recruitment; Munster; Hybrid; EUR 55,000 - 96,000; Part time

Job summary

Pale Blue Dot Recruitment is seeking an experienced Quality Assurance Contractor for an established medical device company. You will oversee the quality management system, ensure compliance with ISO 13485 and EU MDR, and respond promptly to customer quality enquiries.

The assignment starts January 2027 and is ongoing, with a hybrid schedule—one day onsite in Shannon and half a day remote, with potential to adjust by agreement.

Qualifications

• Experience overseeing a quality management system in the medical device industry.
• Practical knowledge of ISO 13485 and EU MDR.
• Experience with US FDA medical device quality system requirements is essential.

Responsibilities

• Review and maintain the existing quality management system in line with ISO 13485 and EU MDR.
• Identify gaps in the system and follow up on actions.
• Coordinate timely responses to customer quality enquiries.
• Support responses to FDA queries related to medical devices entering the US market.
• Collaborate with QA consultant and internal team on quality and regulatory matters.

Skills

Quality management system

ISO 13485

EU MDR

FDA experience

Written communication

Independent work

Job description

Pale Blue Dot® Recruitment is recruiting an experienced Quality Assurance Contractor for an established medical device company with mature product lines. You’ll oversee the company’s existing quality management system, support compliance with ISO 13485 and EU MDR, and make sure customer quality enquiries are answered promptly.

The assignment is expected to start in January 2027 and continue on an ongoing basis. The working days are flexible. The anticipated split is one day onsite in Shannon and half a day remotely, with scope to reverse that arrangement by agreement.

Responsibilities

Review and maintain the existing medical device quality management system in line with applicable ISO 13485 and EU MDR requirements.

Identify any gaps in the system and follow up on agreed actions.

Coordinate timely responses to customer quality enquiries.

Support responses to FDA queries or concerns relating to medical devices entering the US market.

Work with the company’s existing QA consultant and internal team on quality and regulatory matters.

Job requirements

Experience managing or overseeing a quality management system in the medical device industry.

Practical knowledge of ISO 13485 and the EU Medical Device Regulation (MDR).

Experience with US FDA medical device quality system requirements is essential, along with the ability to support responses to FDA queries.

Strong written communication and the ability to work independently within a part-time schedule.

The role may suit an experienced QA professional looking to reduce their hours, return to quality after a career break, or add a regular assignment to their consulting work.