Provide Quality Engineering support to PCBA manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Quality Engineering support to product development teams, helping to ensure development of highest quality new products. Develop, establish, and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Supervise Quality Engineering & Quality Technician team and oversee the quality activities in the area. Create a strong team culture around high expectations & high performance. Key partner in forming and evaluating the production area strategy for the PCBA production unit. Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. Working in partnership with Process Development group this person will support the introduction of new products & processes. Leads process improvement efforts by performing appropriate analysis methods to enhance sustaining product design and new product development. Lead on Preventive Quality initiatives in the value stream. Coordinates and conducts technical investigation and documentation of non-conforming events and trends, and develop technical investigation plans using Engineering Essentials. Leads investigations on customer internal & external complaints. Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes. Develop and/or review Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies, Design of Experiment (DOE), production control plans on sustaining and new products. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Provide clear communication to stakeholders at key technical updates Higher Level Degree/Level 8 qualification in Engineering/Quality/Science with a minimum 5 years' experience in a Medical Device environment or related industry. Demonstrate strong leadership skills, communication skills and promote quality at source. Develop plans and execute on time to these plans. Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets. Experience/training in problem solving and process improvement methodologies (Engineering Essentials).
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