Quality Systems Lead — Medical Devices (Remote)

Mira; Warszawa; On-site; PLN 167,400 - 234,360; Full time

Benefits offered by this job

Flexible remote work

Competitive salary

Job summary

Mira is seeking a Quality Systems Specialist to maintain the QMS, conduct product compliance reviews, and train staff on SOPs. You will collaborate with R&D and regulatory teams to ensure global regulatory compliance in a fast-paced, startup environment.

Remote role based in Poland, with responsibilities including document control, CAPA, audits, and continuous improvement to support FDA, Health Canada, TGA, and MDSAP compliance across product lifecycles.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related field.

Responsibilities

• Maintain the QMS and support regulatory compliance activities.
• Conduct product compliance reviews and support audits (FDA, Health Canada, TGA, MDSAP).
• Train personnel on SOPs and quality procedures.

Skills

Regulatory knowledge

Quality Systems

Auditing

Documentation control

CAPA management

Data analysis

Cross-functional collaboration

Regulatory standards (FDA, CMDR, TGA)

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Tools

QMS software

Document control systems

Job description

Mira is seeking a Quality Systems Specialist to maintain the QMS, conduct product compliance reviews, and train staff on SOPs. You will collaborate with R&D and regulatory teams to ensure global regulatory compliance in a fast-paced, startup environment.

Remote role based in Poland, with responsibilities including document control, CAPA, audits, and continuous improvement to support FDA, Health Canada, TGA, and MDSAP compliance across product lifecycles.