Working at Freudenberg: We will wow your world!

Responsibilities:

• Approve and release changes in documents according to document control
• procedure.
• Collect and maintain files of the latest revision level documentation necessary to define product configuration and control manufacturing processes.
• Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution.
• Maintain a computer database of all filed documentation that ensures fast retrieval of documents.
• Perform clerical typing duties to generate documents as necessary.
• Perform duties as defined in document control policies and procedures.
• Maintain complete, legible, and accurate records.
• Audit DHR’s and release product based on the Quality Control results and
• manufacturing records.
• Working with managers or supervisors to identify and meet personnel training
• needs.
• Establish training and entry-level requirements for key training positions and implement programs to select and develop training personnel. Deliver introduction of quality system training.
• Evaluating regulatory initiatives in training and recognizing the changing educational and experience background of employees. Plans should be developed that address such factors, and the plans adjusted as requirements change.
• Track training needs to avoid expire training records. Monitor the effectiveness of training.
• Maintain control and traceability related to tooling inside shop and outside vendors.
• Monitor and control action plans implementation related to equipment investigation reports.
• Assists the Quality Systems area in the planning, organizing, directing and monitoring of Internal Audit operations, including taking corrective actions to address performance problems.
• Assists with the identification and evaluation of the organization’s risk areas and provides major input to the development of the Annual Audit Plan.
• Manages the performance of audit procedures, including identifying and defining issues, developing criteria, reviewing and analyzing evidence, and documenting processes and procedures.

Qualifications:

• Minimum of 3-5 years' experience in the Quality Assurance department of a medical device company required.
• High school diploma or equivalent.
• Technical degree in quality control or similar.
• Student in Engineering career or related field.
• Internal Auditor Certificate (ISO 13485 or similar) desirable.
• Knowledge of federal and international medical device regulations is required.
• Knowledge of Good Manufacturing Practices (GMP’s).
• High-level computer knowledge (Excel, Word, E-mail, Change Control, Power Point)
• Demonstrated ability to communicate verbally and in writing at a level commensurate with regulatory and technical

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.