Working at Freudenberg: We will wow your world!

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.

Qualifications:

• Bachelor's degree in engineering or related field.

• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA)

• 2 - 5 years' experience in quality engineering.  

• 3 - 5 years engineering experience in the medical device industry preferred.

• Knowledge of injection molding process.

• 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.

Preferred:

• Project management experience

• Regulatory Assurance Certification (RAC).

• Lean/Six Sigma certification.

The Freudenberg Group is an 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.

Freudenberg Medical LLC