Senior QA Engineer - Process Risk, PFMEA & ISO Compliance

Lancesoft; Mannford (OK); On-site; USD 85,000 - 110,000; Full time

Job summary

Lancesoft is seeking a Quality Engineer on-site in Oklahoma to support manufacturing process risk identification, evaluation and mitigation for day-to-day operations and new product introductions. You will lead or contribute to PFMEA, control plans and training while coordinating test protocols and reports.

The role requires BS in engineering or equivalent, knowledge of ISO 13485/14971, and PPAP close experience.

Qualifications

• BS in engineering or equivalent.
• Experience leading PFMEA and control plans.
• Knowledge of ISO 13485 and ISO 14971.
• PPAP close experience.
• Auditing of supplier/quality systems.
• Ability to train others.
• Ability to create and review test protocols/reports.
• Knowledge of Quality Engineering Body of Knowledge.
• Experience with Minitab or equivalent.

Responsibilities

• Supports process risk identification, evaluation and mitigation in daily operations.
• Manages multiple projects with deadlines.
• Integrates business and manufacturing priorities to solve complex problems.
• Acts as a key contributor in a complex environment and works independently.

Skills

CQE

CSSBB

PFMEA

Control plans

Training abilities

Risk management

Quality systems

Minitab

Education

B.S. in Engineering

Tools

Minitab

Statistics

Job description

Lancesoft is seeking a Quality Engineer on-site in Oklahoma to support manufacturing process risk identification, evaluation and mitigation for day-to-day operations and new product introductions. You will lead or contribute to PFMEA, control plans and training while coordinating test protocols and reports.

The role requires BS in engineering or equivalent, knowledge of ISO 13485/14971, and PPAP close experience.