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A Senior Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs. Lead on-time completion of Quality Assurance (QA) engineering deliverables. Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems. Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems. Develop and lead training for QA systems. Influence and guide other team members with product review and analysis for QA activities. Maintain databases and record storage for QA systems. Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals. Lead meetings and communications for QA system information, concerns, and updates. Lead and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics. Track and proactively identify concerns manufacturing related complaints in alignment with SJM goals. Plan ahead for various data storage needs and communicate plans clearly to prevent potential system issues. Seeks out information independently and able mentor/lead other members of the organization on QA practices. Lead Global CAPA team with training, CAPA oversight, and CAPA deliverables. Proficient as lead representative for presenting QA System to internal and external auditors. Investigate and resolve system nonconformances and concerns (defined during internal and external audits). As appropriate, leads in the completion of risk assessment, as related to QA systems. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. Operates a motor vehicle for trips to various Company sites and outside vendor, field, and customer locations; and to commute to various airports for airline. Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees. Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred) 5+ years technical experience Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies Detailed knowledge of FDA, GMP, and ISO 13485 Solid communication and interpersonal skills Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner Advanced computer skills, including statistical/data analysis and report writing skills Prior medical device experience preferred ASQ CQT, CQE, CQA certification preferred Six Sigma root cause analysis/problem solving training and experience preferred. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 10%, including internationally. Ability to maintain regular and predictable attendance.
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