Lead Quality Engineering activities for design, development, manufacturing and/or distribution of orthopedic implants and instruments to ensure a high level of process and product quality.
Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business.
Ensure compliance to regulation and standards. Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
Work closely with operations and the business functions to ensure quality performance of product and processes. Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
Lead and participate in the development and improvement of the manufacturing processes for existing and new products. Analysis and review of concession requests.
Review and approval of change management activities. Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary. Support execution and analysis of QATs.
Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation. Proficient in risk management practices and tools, having high expertise in process risk.
Develop and provide input for risk management by identifying opportunities and weaknesses. Proficiency in and makes continuous strides towards optimization of inspection methods and sampling.
Support First Article Inspections. Proficiency in statistical methods and application. Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
Assist in the development, responsible for review & approval of process and equipment validation/qualification. Support manufacturing transfers to other plants/facilities, leading quality activities.
Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
Coach and mentor others in quality topics and activities.
Bachelor of Science, Engineering or related subject with 2 or more years of experience in a quality discipline.
Previous experience in a regulated environment desirable.
CQE or equivalent course work / experience desirable
Proficient in understanding of Med Device manufacturing processes desirable