Quality Engineer II

Freudenberg Group • Baldwin Park, CA

23h

About The Position

The Quality Engineer II at Freudenberg supports new product development and product maintenance for medical devices by applying Quality engineering skills. This role involves supporting plant activities related to process validation, process capability, and customer issues, initiating corrective and preventive actions to enhance capability, reduce inspection efforts, and improve customer satisfaction, while also supporting Quality System implementation. The engineer will manage and implement manufacturing inspection, sampling, and statistical process control methods to ensure product quality and assure compliance with internal and external specifications and standards like GMPs, GDPs, ANSI, and ISO regulations. Key responsibilities include leading root cause investigations and determining corrective and preventive actions for NCMRs and CAPAs, and verifying their effectiveness. The position requires working on complex issues that demand in-depth evaluation of variable factors and exercising judgment in selecting appropriate methods and techniques. Freudenberg is a global technology group with 51,000 employees, committed to making the world cleaner, healthier, and more comfortable, and offers a networked and diverse environment for individual growth.

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 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.

Benefits

• Equal opportunity employer that is committed to diversity and inclusion.
• Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

What This Job Offers

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