5 Core Tools of Quality - Medical Device Manufacturing

Job Description: You will be responsible for implementing Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effects Analysis (FMEA), Measurement Systems Analysis (MSA), and Statistical Process Control (SPC) methodologies to ensure the highest quality standards are met in the production process. Key Responsibilities: - Implement Advanced Product Quality Planning (APQP) processes to ensure proper planning and risk assessment throughout the product development lifecycle. - Conduct Production Part Approval Process (PPAP) activities to ensure that all parts meet the required quality standards before production. - Perform Failure Mode and Effects Analysis (FMEA) to identify and address potential failure modes in the production process. - Conduct Measurement Systems Analysis (MSA) to ensure that measurement systems are capable of providing accurate and reliable data. - Implement Statistical Process Control (SPC) techniques to monitor and control the production process to maintain quality standards. Qualifications Required: - Bachelor's degree in Engineering or related field. - Strong understanding of Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effects Analysis (FMEA), Measurement Systems Analysis (MSA), and Statistical Process Control (SPC) methodologies. - Excellent analytical and problem-solving skills. - Ability to work effectively in a team environment and communicate with cross-functional teams. ,