Supplier corrective actions and continuous improvement
Mitigate supply risk
The Source Quality Engineer is responsible for ensuring the quality, compliance, and continuity of materials, components, and outsourced manufacturing/processes that support medical device products
Job Summary
The Source Quality Engineer is responsible for ensuring the quality, compliance, and continuity of materials, components, and outsourced manufacturing/processes that support medical device products.
This role leads to supplier qualification and performance management activities, drives supplier corrective actions and continuous improvement, and partners cross-functionally to mitigate supply risk and support product launches and lifecycle changes in a regulated environment and according to internal procedures.
You will be responsible for providing quality engineering leadership in the management of select contract manufacturing and supplier sites engaged in the production and delivery of Johnson and Johnson products and services.
Matching Summary
The Source Quality Engineer is responsible for ensuring the quality, compliance, and continuity of materials, components, and outsourced manufacturing/processes that support medical device products.
Skills & Requirements
Must-have
Supplier qualification and performance management
Supplier corrective actions and continuous improvement
Mitigate supply risk
Support product launches and lifecycle changes
Supplier auditing and compliance assessment
Investigate product and processing complaints
Nice-to-have
Drive reliability and foster culture of quality
Technologically savvy
Persistence and tenacity
Key Requirements
2 to 4 years' experience in a highly regulated industry
Strong knowledge of GMP/GDP, FDA/ISO regulations
Demonstrated experience managing supplier nonconformance, CAPA, and change control
Direct experience performing supplier audits
Demonstrated problem-solving skills with root-cause analysis