Spec 3, Quality Assurance

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

• 12CRF820
• CQE, CSSBB
• Experience leading / creating PFMEA and Control plans, applying knowledge of product, process, and observations from operators
• ISO 13485
• ISO 14971
• PPAP close
• Supplier / Quality System Auditing

• Ability to create and provide training
• Ability to create, review and coordinate test protocols and reports
• Bachelor of Science in an engineering degree or equivalent
• Demonstrates knowledge of process risk management activities and quality management systems
• Has knowledge and skills within the Quality Engineering Body of Knowledge.
• Minitab or equivalent
• MS Word and Excel
• Problem solving ability
• Strong interpersonal skills

Supports manufacturing process risk identification, evaluation and mitigation for day-to-day operations, new product introduction and continuous improvement of the quality management system.

This position handles multiple projects/programs while keeping to key deadlines. Integrates knowledge of business and functional priorities to address complex problems and non-standard situations. Acts as a key contributor in a complex environment and works independently with minimal guidance.

Pay Range: 32-40/hr *based on experience