Working at Freudenberg: We will wow your world!

Responsibilities:

• Lead and maintain the Quality Management System in compliance with ISO 13485 requirements.

• Plan and oversee internal, external, and regulatory audits.

• Manage CAPA (Corrective and Preventive Actions), deviations, and non-conformances.

• Oversee process validations (IQ, OQ, PQ).

• Develop relationship with customer quality management.

• Lead / oversee customer / external audit(s).

• Collaboratively create development plans and goals, coach individuals in achieving them.

• Ensure quality performance metrics are implemented, monitored and addressed. 

• Understand and follow all the HSE policies and procedures and ensure the Quality Department be align with these policies and procedures.

• Ensure Quality department’s participation in the Growtth (Lean) program.

• Conduct management review meetings and ensure closures of management review items.

• Oversee CAPA Review Board (CRB) and ensure appropriate actions are taken to resolve QNs in a timely manner.

• Responsible for implementing new or revised global quality systems requirements.

• Participate in strategic planning activities to ensure that quality related requirements are included in strategic goals and objectives.

• Provide quality solutions to support business activities and other assigned task to support the business.

Qualifications:

• Bachelor’s degree in engineering, Biomedical Engineering, Industrial Engineering, Chemistry, or related field.

• Minimum of 8 years of experience in quality management within the medical device industry, preferably in Contract Manufacturing. Molding experience is a Plus.

• 5+ years' experience in demonstrated ability to manage, coach and mentor employees.

• Effective and competent management, leadership, and organizational skills required and valued as part of the leadership team.

• Proven experience implementing and maintaining compliance with ISO 13485.

• Advanced English proficiency (required for international operations).

• Experience in a metric driven culture.

• Previous experience participating in or leading a Quality audit or section of an audit.

• Electronic Quality Management System.

• Able to review and analyze data and documentation.

• Good reasoning abilities and sound judgment.

• Trustworthy, discrete and a high degree of personal integrity to maintain sensitive and confidential information.

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.