Quality Engineer - Validation & Compliance (Med Devices)

Actalent; Knoxville (TN); Sur place; USD 69 000 - 96 000; Plein temps

Résumé du poste

Actalent is seeking a Quality Engineer to support global quality teams in a medical device manufacturing setting. You will develop and validate procedures, ensure FDA/ISO compliance, and drive continuous improvement across design, development, and production.

Responsibilities include leading validation activities, managing IQ/OQ, creating risk assessments, performing CAPA, and training staff while reporting to the Quality Manager. A strong statistical background is essential.

Qualifications

• Quality system integrity and regulatory compliance focus.
• Regulatory compliance within medical device manufacturing and quality management systems.
• Advanced statistical analysis using quality engineering tools (SPC, DOE, ANOVA, X-bar).
• Lean Six Sigma-based process improvement and project justification.
• Design Control principles for medical devices and validation documentation.
• Strong report writing and presentation skills.

Responsabilités

• Lead validation activities for product processing, packaging, and utilities; write protocols and secure approvals.
• Collaborate across Quality Control, Quality Assurance, Operations, Engineering, R&D to plan validation activities and document results.
• Maintain cleaning validation matrix and evaluate products for appropriate cleaning validation.
• Manage IQ/OQ for equipment qualification and maintain validation master plan.
• Ensure FDA/ISO regulatory compliance and communicate project status to Quality Management.
• Apply statistical analysis to resolve complex technical issues and improve product quality.
• Conduct FMEA and CAPA activities and drive continuous improvement.

Connaissances

Quality systems

Regulatory compliance

Statistical analysis

Lean Six Sigma

Medical devices

Project management

Design Control

Communication skills

Documentation

Training

Internal auditing

Formation

Bachelor's degree in Engineering, Chemistry, Physics, Biology

Outils

Minitab

Description du poste

Actalent is seeking a Quality Engineer to support global quality teams in a medical device manufacturing setting. You will develop and validate procedures, ensure FDA/ISO compliance, and drive continuous improvement across design, development, and production.

Responsibilities include leading validation activities, managing IQ/OQ, creating risk assessments, performing CAPA, and training staff while reporting to the Quality Manager. A strong statistical background is essential.