Evaluate and ensure manufacturing engineering operations can have a steady and robust supply of all components required to maintain daily production. This includes planning and implementing any work necessary to address supplier changes to efficiently implement and sustain supply.to produce products and develop processes to ensure quality, cost, and efficiency requirements. This also would include projects required to implement regulatory changes and/or development of alternate critical suppliers to ensure continuous supply. Lead and manage key process items to bring reduce overall product/component cost and improve efficiency of manufacturing operations. Job Details/ Responsibilities Ensure suppliers are assessed and highest risks are identified and addressed to ensure the most robust component supply possible. Develop strong relationships with TAS suppliers and support any changes in an efficient and collaborative manner. Ensure new suppliers are robust and financially viable for projected long term growth including support in product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc. Lead the conversion of small-scale processes into commercially viable large-scale operations. Lead DO - Es, TM - Vs and software validation as necessary Support Quality system items such as CAPAs, NC - Rs, CQ - Ps, TM - Vs, etc. Recommend modifications/improvement where advisable to minimize cost. Provide primary direction for Quality System implementation, maintenance, training, and facilitation for compliance to quality system requirements for manufacturing and engineering staff. Job Responsibilities (continued) Working Conditions/ Physical Requirements QUALITY REQUIREMENTS: Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives. Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality. Responsible to ensure facility, processes and documentation always remain in a state of audit readiness. EH&S REQUIREMENTS: Take care of your own health and safety and that of others who maybe affected by your actions. Work co-operatively to highlight issues affecting Environmental Health and Safety Knowledge, Skills and Abilities (KSA) Excellent written and verbal communication Understanding of quality system (ISO 13485, 21 CFR 820) regulations Strong leadership skills Ability to interact with all levels within organization. Ability to delegate and motivate subordinate staff. Analytical skills for compiling and analyzing data. Computer and software skills Understanding of supply chain activities Problem solver able to think analytically. Qualifications/ Background Experiences 4 - year engineering degree or equivalent experience 7 years of experience in a technical role in the medical device industry Project management experience in the medical device industry Experience and understanding of quality system regulations (e.g. 21 CFR 820, ISO 13485). 5 years of medical device manufacturing Statistical and process controls experience, including experience with Design of Experiments, qualifications, and validations.