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Corrective and Preventative Action (CAPA) Engineer

Company: New World Medical
Location: Rancho Cucamonga
Posted on: September 15, 2020

Job Description:

New World Medical is a growing medical device company based in Rancho Cucamonga. We were founded with the mission of benefiting humanity. Our firm works to live up to this lofty goal by developing, manufacturing, and marketing cutting-edge medical devices intended to alleviate the suffering of glaucoma patients globally.Our mission is to preserve and enhance vision by delivering innovation to all of humanity through safe and effective medical devices. We commit to our company-wide core values:INTEGRITY - ACCOUNTABILITY - INNOVATIONThe CAPA Engineer is responsible for implementing and progressively improving the Corrective and Preventative Action, (CAPA) process and electronic system within the Quality Management System.The CAPA Engineer is responsible for leading and facilitating improvement efforts across the company utilizing the CAPA quality system process and will report directly to the Quality Systems Manager.ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:Lead CAPA projects.Employ risk analysis tools to determine appropriate internal and external corrections required.Develop and employ sound investigative techniques to fully understand and document problems.Utilize, lead, and facilitate formal Root Cause analysis/techniques.Determine, verify, implement, and measure effectiveness of corrective actions.Thoroughly document all aspects of the CAPA process to develop an audit ready CAPA record.Interface with cross-functional teams throughout CAPA process to ensure effective outcomes.Determine training needs for changes implemented through the CAPA process.Complete CAPAs in an efficient and effective manner in order to meet the company's metrics for the effectiveness of the CAPA process.Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.Accountable for leadership and oversight of the CAPA system, and associated deliverables.Provide guidance, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements.Lead and/or contribute to continuous improvement initiatives and projects.Provide subject matter expertise during audits and inspections.Represent CAPA QA in cross functional meetingsHigh proficiency leading meetings and communications for QA system information, concerns, and updates.Lead, develop, and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices.Other duties as assigned.KNOWLEDGE, SKILLS AND ABILITIES:Ability to work in a team and independentlyExcellent organizational and communications skills as well as attention to detailProblem Solving Skills and creativityAbility to interpret, understand and communicate regulatory requirements as applicable.Capable of training on quality system requirements, concepts, auditing methods and quality procedures, as requiredAbility to remain calm and receptive in fast paced situations.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.Proficient in Microsoft Word/Excel/Outlook/PowerPoint/Visio, including statistical/data analysis and report writing skills.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Multitasks, prioritizes and meets deadlines in timely manner.EDUCATION AND EXPERIENCE:Bachelor's Degree Preferably in Engineering, Technical Field, Life Science or closely related discipline or an equivalent combination of education and work experience.Minimum 6 years in Quality or related field experience.Previous CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies.Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.New World Medical, Inc. (NWM) is an Equal Opportunity Employer. NWM takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Keywords: New World Medical, Rancho Cucamonga , Corrective and Preventative Action (CAPA) Engineer, Engineering , Rancho Cucamonga, California

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