Working at Freudenberg: We will wow your world! Responsibilities:Ensure all customer requirements are identified and clearly documented in Freudenberg Medical manufacturing documentation. This documentation includes CHR's, Work Instructions, Visual Standards, Purchasing Specifications, FMEA's etc.Document manufacturing procedures, CHR's, purchasing specifications, visual standards etc. Review and approve all updates to same.Investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using the Freudenberg Medical CAPA system.Assess all product and manufacturing related changes, deviations and reworks, for their impact on validations, product quality and the customer.Review, control and disposition non-conforming product in accordance with the Freudenberg Medical NCR system.Make product dispositions as and when required. Update documentation such as specifications and visual standards to better define the quality characteristic being dispositioned.Prepare process data such as yield, output rates, No. of NCR's etc. and use this data to identify opportunities for improvement. Implement improvements on an ongoing basis.Perform internal audits as per agreed schedule and assist with preparations for external audits.Write validation protocols, reports and test reports as required.Perform First Article Inspections as required.Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrences, near misses/illness, good catches and environmental incidents in a timely manner.Take on other duties which the Company may assign you from time to time. These 'other duties' will be agreed with Management prior to any assignment.Qualifications:Degree / Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry.A minimum of 3 years experience in a similar role.Excellent attention to detail.Ability to use problem-solving tools (A3, PDCA, 5 Why's, Fishbone etc.)Good communication skills both verbal and written.A positive attitude in dealing with people.Experience working with Data Analysis Software (i.e. MiniTab) an advantage.Understanding of lean principles. Lean green belt an advantage.Ability to learn and adapt to various situations.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.
About UsWelcome to Freudenberg
Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
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