Quality Systems Specialist
TSI Incorporated, Shoreview, MN, United States
Who Are We? Do you want to help to make the world a better place? Join our team! At TSI our vision is to create a better world by helping to protect people, products and the environment. We are proud of the wide range of solutions we provide that solve our customer's problems around the world. From helping to ensure worker safety and understanding air quality to supporting complex highly technical industries such as pharmaceuticals manufacturing, semiconductor, and research customers, TSI employees are part of something special with a purpose. Quality Systems Specialist at TSI The Quality Systems Specialist will ensure TSI Quality Management System (QMS) is able to consistently provide products & services that meet customer and applicable statutory & regulatory requirements. This role will lead TSI's internal audit program and facilitate external audits. This position is responsible for effective management of TSI QMS processes per ISO 9001:2015, ISO 17025:2017, ISO/IEC 80079-34-2018, and BS/EN 15267-2:2009. What Will You Do? In order to grow and build a successful career with TSI, you will be responsible for: * Monitor applicable QMS & regulatory requirements and implement changes to internal processes & procedures as needed. * Maintain QMS documents to ensure the effective planning, operation, and control of its processes using SharePoint based E-QMS. * Facilitate third party (customers and regulatory agencies) quality audits to ensure compliance with established policies and procedures. * Participate in and manage the Internal Audit program. * Conduct vendor quality system audits. * Oversee and assist with internal Corrective Action process. * Act as an on-site quality representative for regulatory and compliance agencies. * Complete customer quality questionnaires and surveys. * Monitor customer complaint trends and coordinate investigation activities. * Lead and participate in process improvement activities. * Develop and conduct basic quality training for new employees. * Manage the QMS training program. * Perform other duties and special projects as requested. What Do You Need? Required * Bachelor's degree OR equivalent combination of education and experience required * Minimum of three years of experience working with Quality Management Systems. Desired * ASQ Certified Quality Auditor (CQA) * Principles, practices, techniques, and theories of internal control and auditing standards. * Corrective Action process * ISO 9001:2015 * ISO 17025:2017 * ATEX/IECEx requirements What Can We Give You? At TSI, our employees are our most valuable assets, and we care about their health and happiness. We offer a competitive benefits program to keep our employees and their family members protected and foster a healthy work-life balance. Additionally, we are committed to employee development and growth, and encourage and foster an environment of collaboration, and innovation. Our work has meaning and the products we design and build help protect people and the environment. Dress for your day: We want our employees to be comfortable at work and we know they are more productive when they're comfortable. The dress for your day policy allows employees' discretion to select appropriate dress for the business of each workday. Free Beverages/On-site Cafeterias: Enjoy complimentary coffee, tea and hot chocolate each day at work. We also have two large cafeteria's employees can eat lunch in, as well as an outside patio area that employees can enjoy during the summer months. Benefit Offerings: Competitive medical insurance plans, life insurance, short-term and long-term disability, 401K Employer Contribution, Flexible Spending Account, Education Assistance, and more. Legal authorization to work in the United States without the need for sponsorship. We require proof of eligibility to work in the United States. EOE/M/W/Vet/Disability TSI provides trusted measurement, application guidance, and data analytics solutions that enable our global custome s to make informed decisions. We are creating a better world by helping protect people, products and the environment, as well as by optimizing research and industrial processes. Nearest Major Market: Minneapolis Job Segment: Compliance, Air Quality, Law, Internal Audit, Semiconductor, Legal, Engineering, Finance, Science