Senior Device Quality Director - Hybrid

GSK plc; Pennsylvania; Ibrido; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

GSK plc is seeking a quality engineer to lead medical device quality activities across design, manufacturing and regulatory teams. You will ensure product safety, reliability and compliance while influencing patient outcomes with data-driven decisions.

The role is hybrid with regular onsite collaboration in the United States and some remote flexibility; 5+ years' experience in medical device quality engineering or regulated manufacturing is required.

Competenze

• Bachelor's degree in a relevant engineering field required.
• Minimum of 5 years' experience in medical device quality engineering or regulated manufacturing.
• Knowledge of ISO 13485 and FDA 21 CFR 820 expected.
• Hands-on root cause analysis and CAPA execution demonstrated.
• Ability to read drawings, specs and test data; strong cross-functional communication.

Mansioni

• Provide quality oversight of device design control activities for new products.
• Lead design transfer and manufacturing scale-up for robust processes.
• Ensure compliance with ISO 13485, FDA 21 CFR 820 and global requirements.
• Oversee risk management files (ISO 14971) and D&D files (ISO 13485).
• Drive QMS improvements and investigate quality events with RCA/CAPA.
• Review quality documents, protocols and test reports; support audits.

Conoscenze

Quality engineering

Medical devices

Root cause analysis

CAPA

Cross-functional collaboration

Documentation

Regulatory compliance

Formazione

Bachelor's degree in biomedical, mechanical, electrical engineering or related field

Descrizione del lavoro

GSK plc is seeking a quality engineer to lead medical device quality activities across design, manufacturing and regulatory teams. You will ensure product safety, reliability and compliance while influencing patient outcomes with data-driven decisions.

The role is hybrid with regular onsite collaboration in the United States and some remote flexibility; 5+ years' experience in medical device quality engineering or regulated manufacturing is required.