Working at Freudenberg: We will wow your world!

Responsibilities:

• Verify company’s adherence to the established Quality System and GMP/ISO standards.

• Completion of risk management and risk analysis including FMEA.

• Work with Customers to revise design verification and design validation plans for products based on performance specifications and risk analysis.

• Supports technical and statistical investigations concerning optimization and compliance to specification.

• Owner of measuring process capability, process controls, and process validation / efforts.

• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.

• Conducting NCMR Investigations, Calibration Out of Tolerance (OOT) Investigations and Complaint Investigations related to manufacturing Process.

• Works closely with Management positions on completing and documenting Monthly Quality Data Review, providing data analysis and escalation recommendations.

• Leading Build at Risk (BAR) Authorizations & Closures.

• Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.

• Creation and maintenance of Quality Plans and Reports.

• Executing and authoring IQ, OQ, and PQ Qualifications and Inspection and Test Method Qualifications.

• Conducting Advanced Statistical Data Analyses using Minitab.

• Authoring Master Validation Plans and Reports.

• Supports activities during preparation and execution of audits (External / Internal), functioning as SME backup for specific Quality activities.

• Creating and Communicating details and information of events related to quality to upper management.

Qualifications:

• Bachelor’s degree (required) in engineering (preferred) or similar.

• 4-6 years of experience in related positions.

• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).

• Knowledge of statistical, data analysis.

• Knowledge in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.

• Experience with control of nonconforming material, corrective and preventive actions.

• Experience working on FDA, GMP, and ISO 13485 regulations.

• Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.

• Project management experience, participating or leading multi-departmental project teams.

• Advanced command of English language (required).

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 srl.