Quality Assurance Spec 3

Lancesoft

Mannford (OK)

On-site

USD 85,000 - 110,000

Full time

10 days ago

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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

On site 5 days a week 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 equival

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.

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