Job Description

The Quality Assurance Engineer will support the development and maintenance of ASP products and the quality system. Responsibilities: + Provide expertise and experience with general manufacturing processes for Medical Device Capital Equipment or Medical Devices + Knowledgeable of nonconformance systems and of the requirements for first article inspection, incoming, in process inspections, and lot release testing, including sampling strategies and test methods + Provide expertise on FDA Quality Systems regulations, and ISO 13485 + Proficient in the understanding of regulatory requirements for medical devices and will demonstrate proficiency with statistical methods, sampling, design of experiments, process capability analysis, FMEA, and FTA hazard analysis + Experience using Six Sigma methodology, be able to perform process variability studies, risk analysis and test method variability, will review and approve validation and qualification protocols and support the execution of process / product qualifications & validations (IQ, OQ, PQ) + Provide support to develop and maintain documentation to support the validation process, specifications, manufacturing and test procedure and will participate and collaborate with supply chain, R&D engineering, operations engineering and manufacturing to identify potential areas of process variability, address root causes and implement improvements + Possess leadership skills and will have a strong electrical engineering or mechanical engineering background in Medical Device Capital Equipment or Medical Devices, will be responsible for resolving Manufacturing and Supplier related issues of ASP products and will devise and implement methods and procedures for inspecting, testing and evaluating production + Provide technical QA support to assigned inspection and manufacturing area(s) + Participate in process evaluations (e.g. FMEA's), develop and execute manufacturing process valuations, will determine appropriate sampling plans for subsequent routine production and will participate in the training of new and lower level quality engineers + Responsible for communicating business related issues or opportunities to next management level + Perform other duties assigned as needed Experience: + Experience with non-conformances. FMEAs, and CAPAs is required + Working knowledge of first article inspection, in-coming/ in-process inspections, lot release testing and sampling plans required + Experience in a FDA regulated environment preferred + Experience with Medical Devices highly desired ▪ Prior experience with FDA audits would be a plus + Experience working with cross functional teams such as Engineering, Operations, Supply Chain, Suppliers, New Product Development etc, is desired + Experience with reading and interpreting mechanical drawings preferred ▪ Ability to lead and/ or mentor others highly desired + Any quality related certifications or trainings would be a preference Qualifications: + Minimum of 6 years related experience OR a minimum of a MS degree with a minimum of 4 years related experience OR a PhD with a minimum of 2 years related experience is required. Preferred 8+ years of experience Internal Interactions: + Lead Core Teams + May directly or indirectly manage Analysts, Quality engineers, Interns or support personnel + May collaborate with R&D, PM, Supplier Quality and Operations on NPD/LCM projects. This may include protocol/report approval External Interactions: + May interface with contract laboratories on behalf of ASP + May interface during audits with regulatory agencies or customers Travel Expectations: + 10-20% Domestic **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 17,000 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. **About Advanced Sterilization Products** ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP's mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP's products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning. 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 application process, please contact us at [email protected]. **Bonus or Equity** This position is also eligible for bonus as part of the total compensation package. **Pay Range** The salary range for this position (in local currency) is 101,500.00 - 188,500.00 This position is also eligible for bonus as part of the total compensation package. The salary range for this position (in local currency) is 101,500.00 - 188,500.00 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 application process, please contact us at [email protected].

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Contract work, Local area,

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