Quality Assurance Engineer – PFMEA, ISO 13485 & Risk

Planet Pharma; Warwick (OK); On-site; USD 44,000 - 55,000; Full time

Job summary

Planet Pharma is seeking a Quality Engineer to support manufacturing process risk identification, evaluation and mitigation for daily operations, NPI, and continuous improvement of the quality management system. The role handles multiple projects and programs, meeting tight deadlines and working independently with minimal guidance.

The ideal candidate will have PFMEA/Control plans experience, ISO knowledge, and strong problem solving and training abilities to contribute to supplier audits, test

Qualifications

• Bachelor of Science in an engineering degree or equivalent.
• Experience in PFMEA and Control plans.
• Knowledge of process risk management activities.

Responsibilities

• Supports manufacturing process risk identification, evaluation and mitigation for day-to-day operations, new product introduction and continuous improvement of the quality management system.
• Handles multiple projects/programs while meeting key deadlines and works independently with minimal guidance.

Skills

PFMEA & Control Plans

Quality System Auditing

Training delivery

Test protocols & reports

Process risk mgmt

Quality Eng. knowledge (QBK)

Minitab

MS Word

MS Excel

Problem solving

Interpersonal skills

Education

B.S. in Engineering or equivalent

Tools

Minitab

MS Word

MS Excel

Job description

Planet Pharma is seeking a Quality Engineer to support manufacturing process risk identification, evaluation and mitigation for daily operations, NPI, and continuous improvement of the quality management system. The role handles multiple projects and programs, meeting tight deadlines and working independently with minimal guidance.

The ideal candidate will have PFMEA/Control plans experience, ISO knowledge, and strong problem solving and training abilities to contribute to supplier audits, test