The Freudenberg Group, a global technology group with 48,000 employees in some 60 countries, develops leading-edge technologies, and excellent products, solutions and services for more than 30 market segments. Freudenberg & Co. Kommanditgesellschaft, with its Headquarter in Weinheim, is the strategic parent company of the broadly diversified Group. Freudenberg Medical is a leading global manufacturer of components for medical devices, complex catheter systems for minimally-invasive surgery and total solutions for the biotech, healthcare and pharmaceutical industries.

 

Director of Quality
FDA, ISO 13485 and Medical Device Experience

Your tasks

  • Lead and assist in the development of direct reports to achieve desired results. 
  • Communicate department goals and objectives, ensuring resources are distributed appropriately
  • Maintain regular two way dialogue with direct reports on work and results
  • Collaboratively create development plans and coach individuals in achieving them.
  • Ensure Quality department’s participation in the Growtth (Lean) program.
  • Ensure systems and specific product procedures are in place to release product meeting defined requirements
  • Responsible for leading the development and management of an effective and compliant quality system by working closely with various cross-functional members.
  • Ensure quality performance metrics are implemented, monitored and addressed. 
  • Report to management on the performance of the Quality Management System.

Customer / Regulatory interaction

  • Act as the primary contact for customers regarding quality related issues / activities.
  • Lead / oversee customer / external audit(s)
  • Develop relationship with customer quality / regulatory management
  • Address customer concerns to support strategic approach to the regulations

Compliance

  • Serve as site Management Representative 
  • Coordinate and conduct management review meetings and ensure closures of management review items.
  • Ensure continuing suitability, adequacy, and effectiveness of Freudenberg Medical Quality Management System
  • 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
  • Report and resolve customer recalls and field complaints.

Business Support

  • 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.
  • Promote the awareness of quality throughout the business.

Our expectations

  • Bachelor’s degree in Engineering Discipline such as Mechanical, Quality or related technical field.
  • 15 years of Manufacturing, Product Development, Regulatory  and/or Quality experience
  • 10 years minimum of medical device experience
  • 5 years minimum quality experience
  • 5 years minimum experience in demonstrated ability to manage, coach and mentor employees
  • Knowledge of product regulatory requirements.
  • Experience in a metric driven culture.
  • ISO Quality Systems requirements, FDA GMP, and QSR.
  • Electronic Quality Management System (SAP preferred).
  • Able to review and analyze data and documentation.
  • Effective and competent management, leadership, and organizational skills required
  • Good reasoning abilities and sound judgment
  • Ability to communicate effectively (written & spoken) as required for job related communication throughout the organization.
  • Trustworthy, discrete and a high degree of personal integrity to maintain sensitive and confidential information.
  • Accurate and attentive to detail.
  • Excellent communication and public relations abilities.
  • Ability to assist and support others.
  • Ability to read and interpret documents.
  • Flexibility to work any shift.
  • Ability to travel as needed (30%).

Freudenberg Medical is a global leader in medical contract manufacturing; we offer the following services for medical device, pharmaceutical and IVD clients worldwide − product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms.

Location: Carpinteria, CA

We are currently hiring for a Director of Quality who:

  • Responsible for the overall leadership, management and direction of releasing product, quality system, regulatory compliance, and quality department activities for the Carpentaria facility including InHealth Technologies medical device products.
  • Driven and takes a strong “business partner” approach with strong leadership and management experience to mentor and foster development of the quality team.
  • Hands-on in a dynamic production environment where everyone is challenged by rolling up their sleeves to develop and implement solutions for our customer.
  • Self-motivated and thrives in a fast –paced, cutting-edge, “lean” systems environment, where priorities can often change on a daily basis.

It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match.

Do you have any questions?

Freudenberg Medical
Rachel Peterson ∙ Human Resources ∙ 92 Blackburn Center ∙ 01931 Gloucester, MA ∙ www.freudenbergmedical.com
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