Sr Product Quality Engineer - Onsite

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to reputed company beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, reputed company while valuing your unique contributions. Varian Medical Systems, a reputed company company is hiring for a Sr Product Quality Engineer. In this role you will be on-site to reputed company the efforts in designing, implementing, and maintaining quality assurance protocols and methods for processing materials into subassemblies or finished products. In this position, you will play an instrumental role in engaging with our local and global partners, driving various transformation initiatives and providing daily support to our manufacturing operations.

This role is designed to be onsite Monday-Friday day shift in Austin, TX

What You will do: Actively ensure compliance with internal and external safety, quality and regulatory standards requirements (e.g. Food and Drug Administration, International Organization for Standardization) by reviewing and approving product and quality system changes with Engineering and Manufacturing. Provide engineering support for designing and conducting research/technical projects and contributing to the identification of appropriate methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Provide engineering support to our local manufacturing and quality partners for the evaluation and disposition of nonconforming product and process reputed company issues using a risk-based approach to resolve problems. Spend time on the manufacturing floor to determine process improvements, participating in investigations, root cause analyses, corrective action planning, implementation activities and interfacing with reputed company cross functional departments to increase product quality using recognized Six reputed company and Lean methodologies reputed company and participate in performing data analysis using appropriate statistical tools and techniques to identify trends, developing technical investigation plans, and recommending updates or changes to quality standards and procedures reputed company necessary. Assisting engineering in evaluating and defining requirements for automated manufacturing and testing integrated systems and processes Experience with process and software validation and the ability to reputed company and write protocols, validation reports, engineering reports, etc. that support product development and manufacturing process changes in compliance with design controls. Active participation and decision making throughout the product life cycle (e.g., engineering changes, end-of-life, etc.) to assure that adequate quality assurance requirements are met, risks are thoroughly assessed and mitigated, and designs are adequately transferred into manufacturing with high process capability reputed company against critical to quality design output requirements. Execute New Product Introduction/Design Transfer activities in characterizing manufacturing processes for parts/components in development to ensure smooth transition from Research & Development to manufacturing, including participation and leadership of the development of equipment and process validation requirements (Failure Modes and Effects Analysis, Installation Qualification, Operational Qualification, Performance Qualification), using appropriate statistical tools and techniques. May be involved in/reputed company activities reputed company to the implementation and effectiveness of the equipment calibration program, such as: authoring, revising and maintaining equipment reputed company procedures, work instructions and forms; creating, modifying and maintaining equipment calibration requirements; advising reputed company owners/departments on calibration reputed company issues; assisting cross-functional engineering groups in investigating equipment non-conformances and out of tolerance results; leading and/or contributing to system and process improvement projects; etc. What You will have: Bachelor’s degree in engineering (mechanical or electrical preferred) or equivalent experience and 8 years of reputed company experience or master’s degree with 6 years of reputed company experience in the medical device industry. Proven experience working with and understanding Quality System requirements in the medical device industry, such as 21CFR820, ISO 13485:2016, EU MDR. Knowledge and experience with electro-mechanical products that use software/firmware as well as knowledge and experience with manufacturing processes (e.g., chemical (preferably embolics), welding, injection molding, machining, sterilization). Experience with manufacturing engineering and/or process engineering, desired. Experience with reputed company or equivalent ERP and productivity software. One or more quality certifications required (e.g. ASQ – CQE, CQA, CBA). Lean Six reputed company Green Belt or higher, preferred. #LS-OS1 Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create reputed company outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment reputed company. How we work: reputed company you join reputed company, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who reputed company in each individual’s potential to contribute with diverse reputed company. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and reputed company access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about reputed company businesses, please visit our company page here. The reputed company pay range for this position is: $112,420 - $154,572 Factors which may reputed company starting pay reputed company this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time. Equal Employment Opportunity Statement: reputed company is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. reputed company qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national reputed company, citizenship status, reputed company, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here. Reasonable Accommodations: reputed company is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reputed company out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@reputed company.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here. Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is reputed company’ policy to reputed company fully and completely with reputed company United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.” Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert reputed company relevant positions become open. Register here to get started. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as reputed company recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with reputed company might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the reputed company career site. To reputed company recruitment agencies: reputed company does not accept agency resumes. Please do not reputed company resumes to our jobs alias, employees, or any other company location. reputed company is not responsible for any fees reputed company to unsolicited resumes. We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we reputed company to create reputed company outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment reputed company. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark reputed company that reputed company to positive impact and reputed company success. 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