Quality Assurance specialist 3 - Urgent Need (Req Exp in Medical Device or Regulated Industry)

Millenniumsoft; Mannford (OK); Sur place; USD 51 000 - 73 000; Plein temps

Résumé du poste

Millenniumsoft in Mannford, Oklahoma seeks a Quality Assurance professional for an 11‑month, on‑site assignment at $45/hr. The role focuses on ensuring quality across product and process workflows.

You will lead PFMEA and control plan activities, perform supplier and quality system audits, and develop/test protocols and reports. A BS in engineering is required, with ISO knowledge and strong problem-solving and communication skills.

Qualifications

• BS in engineering or equivalent.
• Experience with PFMEA and Control Plans.
• Knowledge of ISO 13485 and ISO 14971.
• PPAP/PPAP close experience favored.
• Auditing of suppliers and quality systems required.

Responsabilités

• Supports manufacturing process risk identification, evaluation and mitigation for day-to-day operations, new product introduction and continuous improvement of the quality management system.
• Acts as a key contributor in a complex environment and works independently with minimal guidance.
• Coordinates test protocols and reports and provides training when needed.

Connaissances

Problem solving ability

Strong interpersonal skills

Ability to create training

Experience leading / creating PFMEA &

Formation

Bachelor of Science in Engineering or equivalent

CQE

CSSBB

Outils

Minitab

MS Word

MS Excel

PFMEA

Control plans

Description du poste

• 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

Job Title - Spec 3, Quality Assurance

Job Location - Mannford, Oklahoma

Duration: 11 Months

Job Description

Pay rate: $45/hr 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 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.