Remote Quality Engineer — Medical Device Compliance

Pharmavise Corporation; Poland; Remote; PLN 90,000 - 150,000; Full time

Job summary

Pharmavise Corporation is seeking a Quality Engineer to ensure compliance across the product lifecycle for medical devices. This remote role collaborates with R&D, Manufacturing and Regulatory to uphold product safety and regulatory standards.

The ideal candidate has a strong technical background, meticulous attention to detail, and experience with CAPA, risk management, and audit support, contributing to continuous quality improvements worldwide.

Qualifications

• Bachelor’s degree in Engineering or related scientific discipline is required.
• Experience in a regulated medical device environment (FDA QSR, ISO 13485, ISO 14971) is preferred.
• Hands-on experience with process validation, CAPA, risk management, nonconformance investigations, and audit support.
• Knowledge of statistical analysis tools and data-driven quality decisions.
• Strong communication, documentation, and cross-functional collaboration skills.
• Lean Six Sigma certification or similar is a plus.

Responsibilities

• Support design control activities ensuring inputs, outputs, verification, and validation meet requirements.
• Participate in risk management activities (ISO 14971) including FMEA and hazard analysis.
• Review and maintain DHF, technical docs, and change control records.
• Collaborate with R&D, Manufacturing, Regulatory to ensure compliant design transfer into production.
• Support and lead IQ/OQ/PQ validation activities and validation master plans.
• Conduct root cause investigations using 5 Whys, Fishbone, and similar methods.
• Drive CAPA to timely closure and verify effectiveness.
• Monitor production processes and quality metrics for trends and improvements.
• Support equipment qualification, calibration, and validation maintenance.
• Participate in supplier qualification, performance monitoring, and audits.
• Review incoming inspection results, PPAP docs, and supplier process records.
• Maintain and improve QMS per 21 CFR Part 820, ISO 13485, MDSAP, EU MDR.
• Prepare for internal/ external audits and manage documentation.

Skills

Statistical analysis

Quality systems

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering

Tools

SPC

Minitab

MasterControl

TrackWise

Veeva

Job description

Pharmavise Corporation is seeking a Quality Engineer to ensure compliance across the product lifecycle for medical devices. This remote role collaborates with R&D, Manufacturing and Regulatory to uphold product safety and regulatory standards.

The ideal candidate has a strong technical background, meticulous attention to detail, and experience with CAPA, risk management, and audit support, contributing to continuous quality improvements worldwide.