Spec 3, Quality Assurance - Onsite (Req Exp in Medical Device Manufacturing)

Millenniumsoft; Mannford (OK); Sur place; USD 51 000 - 73 000; Temps partiel

Résumé du poste

Millenniumsoft in Mannford, Oklahoma seeks a Quality Assurance Specialist for a 11-month on-site engagement at $45/hr. You will lead PFMEA and control plans, apply process and product knowledge, and coordinate test protocols and reports.

Requirements include ISO 13485/14971 familiarity, PPAP close, and supplier/quality system auditing. The role emphasizes training delivery, risk management, and QA process knowledge within a collaborative team.

Qualifications

• Experience leading or creating PFMEA and control plans.
• Knowledge of ISO 13485 and ISO 14971.
• PPAP close experience.
• Auditing suppliers and quality systems.
• Ability to create and provide training.
• Create, review and coordinate test protocols and reports.
• BS in engineering or equivalent.
• Knowledge of process risk management and quality management systems.
• Knowledge of the Quality Engineering Body of Knowledge.
• Minitab familiarity.
• MS Word and Excel proficiency.
• Strong problem solving abilities.
• Strong interpersonal skills.

Responsabilités

• Supports manufacturing process risk identification, evaluation and mitigation daily.
• Works on new product introduction and quality system improvement projects.
• Manages multiple projects and meets key deadlines while working independently.

Connaissances

PFMEA

Control plans

ISO 13485

ISO 14971

PPAP

Auditing (Supplier/Quality System)

Training delivery

Test protocols & reports

Process risk management

Quality management systems

Quality Engineering Body of Knowledge

Problem solving

Interpersonal skills

Formation

Bachelor of Science in Engineering

Outils

Minitab

MS Word

Excel

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 -

PR:$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.