Medical Device Design Quality Engineer - Onsite

Stark Pharma Solutions Inc; Warszawa; On-site; PLN 327,000 - 462,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking a Design Quality Engineer to support product development, validation, and lifecycle management within a medical device setting. You will ensure design control compliance, maintain the DHF, and collaborate with suppliers to deliver compliant products.

The role requires 3+ years in quality engineering for medical devices, strong regulatory knowledge, and hands-on risk management.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 3+ years of Quality Engineering experience in medical devices.
• Strong knowledge of Design Controls and regulations (FDA 21 CFR Part 820, ISO 13485).
• Experience supporting Product Validation activities.
• Experience with external suppliers and technical document reviews.
• Ability to read engineering drawings, specifications and control plans.
• Hands-on risk management (FMEA, risk assessments).
• Experience maintaining DHF documentation and traceability matrices.

Responsibilities

• Support product validation activities, including review/approval of protocols and reports.
• Collaborate with suppliers and contract manufacturers on documentation and validation packages.
• Ensure changes comply with quality systems and regulatory standards.
• Participate in risk management activities and mitigation planning.
• Develop and maintain DHF documentation for regulatory compliance.
• Create and manage traceability matrices linking design inputs/outputs.
• Support design reviews and proper design control execution.
• Partner with R&D, Manufacturing, Regulatory Affairs and Quality teams.
• Assist with change control and documentation approvals.
• Provide support during audits and inspections.

Skills

Quality engineering

Design controls

Regulatory knowledge

Cross-functional collaboration

Technical writing

Risk management

FMEA

Education

Bachelor's degree in Engineering

Job description

Stark Pharma Solutions Inc is seeking a Design Quality Engineer to support product development, validation, and lifecycle management within a medical device setting. You will ensure design control compliance, maintain the DHF, and collaborate with suppliers to deliver compliant products.

The role requires 3+ years in quality engineering for medical devices, strong regulatory knowledge, and hands-on risk management.