The Quality Systems Engineer will have the responsibilities to implement global quality system elements and global Electronic Quality Management System (eQMS) at ASP in compliance to all regulatory and standard requirements. The Quality Management Systems Control Department consists of the following quality systems elements: Corrective and Preventive Action (CAPA), Non-Conformance (NC), Issue Escalations, Field Action, Data Review Board (DRB), Quality System Management Review (QSMR), Quality Planning and Quality Metrics.

　　Responsibilities:

　　Under limited supervision, general direction, and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

　　Responsible for executing applicable quality system processes and procedures and ensuring quality performance metrics are met.

　　Supports team members to ensure investigations and actions are appropriately addressed and closed in a timely manner.

　　Monitors quality data to ensure appropriate review and escalation through quality management system.

　　Provides audit support audit readiness preparation and post audit activities.

　　Responsible for communicating business related issues or opportunities to next management level.

　　Participate in quality system continuous improvement & initiatives in a multi-functional environment.

　　Performs root cause analysis, develops corrective actions and documents results in the appropriate quality system.

　　Impacts quality of own work and the work of others on the team; works within guidelines and policies.

　　Receives a moderate level of guidance and direction.

　　Solves a range of straight forward problems; analyzes possible solutions using technical experience and judgment and precedents.

　　Our Needs:

　　Bachelor's degree in Engineering, Life Sciences, or Physical Sciences.

　　1-2 years’ experience preferred in Medical Device industry.

　　Knowledge of 21 CFR Part 820, ISO 13485, and MDD/IVDD.

　　Knowledge in quality systems within medical device, pharmaceutical, or other regulated industry.

　　Knowledge in quality management systems databases.

　　Experience in Microsoft Office (Word, Excel, and PowerPoint).

　　Demonstrated problem solving skill.

　　Critical thinker, detailed oriented, organized, and collaborative skills.

　　Excellent written and oral communication skills.

　　Fortive Corporation Overview

　　Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

　　We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

　　We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

　　At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

　　At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

　　At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

　　Fortive: For you, for us, for growth.

　　Ready to move your career forward? Find out more at careers.fortive.com (https://stgfortive.taleo.net/enterprise/careers.fortive.com) .

　　Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.

　　We Are an Equal Opportunity Employer

　　Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should ask to speak with a Human Resources representative to request an accommodation.

　　National: The salary range for this position is $79300 - $147300

　　This position is also eligible for bonus as part of the total compensation package.

　　Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.