Quality Engineer II

Freudenberg • Baldwin Park, CA

6d

About The Position

Supports new product development and product maintenance through the application of Quality engineering skills for medical devices. Supports plant activities in process validation, process capability issues and customer issues, initiates corrective and preventive action, with an eye to increased capability, reduced inspection time/effort, customer satisfaction and supports Quality System implementation. Manage and implement manufacturing inspection, sampling and statistical process control methods and procedures to assure the quality of manufactured products. Assures compliance to in-house and external specifications and standards, such as GMPs, GDPs, ANSI and ISO regulations. Leads investigation of root cause and determination of corrective and preventive actions relating to NCMRs and CAPAs. Responsible for corrective action effectiveness verification. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.

Requirements

• Bachelor's degree in engineering or related field.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA)
• 2 - 5 years' experience in quality engineering.
• Demonstrated knowledge in Quality System Requirements/Good Manufacturing Practices.
• Demonstrated competency in basic statistics, data analysis.
• Demonstrated competency in risk management/hazard analysis, continuous process improvement.
• Understanding of continuous improvement methodologies including lean, six sigma, and validation.

Nice To Haves

• 3 - 5 years engineering experience in the medical device industry.
• Knowledge of injection molding process.
• Project management experience
• Regulatory Assurance Certification (RAC).
• Lean/Six Sigma certification.

Responsibilities

• Supports new product development and product maintenance through the application of Quality engineering skills for medical devices.
• Supports plant activities in process validation, process capability issues and customer issues.
• Initiates corrective and preventive action, with an eye to increased capability, reduced inspection time/effort, customer satisfaction.
• Supports Quality System implementation.
• Manages and implements manufacturing inspection, sampling and statistical process control methods and procedures to assure the quality of manufactured products.
• Assures compliance to in-house and external specifications and standards, such as GMPs, GDPs, ANSI and ISO regulations.
• Leads investigation of root cause and determination of corrective and preventive actions relating to NCMRs and CAPAs.
• Responsible for corrective action effectiveness verification.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees