The Regional CQV Delivery Lead assists CQV activities and teams across the US network. This role involves coordinating the implementation of Global CQV strategies, developing C&Q Plans, and providing oversight to ensure documentation compliance. The role also requires managing staffing, reporting on CQ progress, and collaborating with site teams for successful system handover.
The Senior Quality Systems Specialist plays a key role in operating and maintaining our Quality Management System to support the development of digital therapeutics in compliance with international and US medical device regulations. This role offers a high degree of autonomy and will work closely with the product development team to drive the completion of key software design control, risk management, and change control deliverables for new product development and current on-market products.
Responsible for initial interface on quality issues at customer plant locations, managing activities during product launch to minimize costs and quality issues. This role supports, monitors, and analyzes quality problems, develops corrective actions, and leads quality improvement projects using Lean and Six Sigma. Responsible for processing 0-km issues and warranty field returns.
The Heavy Maintenance Representative supervises and oversees Allegiant Air’s heavy maintenance, modification, aircraft induction work and repairs performed by outside maintenance vendors (MRO). The Heavy Maintenance Representative acts as a company representative directly overseeing work and interfacing with all respective parties to complete the scheduled work with the highest degree of quality, on time and on budget.
Ensure compliance with all applicable Federal, State and Municipal environmental rules and regulations as well as Clarios Corporate Environmental Standards through the implementation and maintenance of an Environmental Management System. Lead and maintain environmental compliance programs, ensuring alignment with facility, regional, corporate, and regulatory standards through audits, inspections, and accurate recordkeeping. Administer environmental management systems, including hazard analysis, spill prevention, hazardous waste handling, emissions, emergency planning, and employee training.
Provide technical expertise to guide on-farm fertility decisions and help deliver a world-class customer experience. Build relationships and provide technical service to Pivot Bio distribution partners and growers. Lead training events and deliver world-class fertility insights, with a focus on nitrogen management, to customers and the sales team.
Implement new technology, transition new business, and assist sales representatives in making technical related sales calls and presentations within the division. Research, identify and define market and product application opportunities for customers with the industry, and assist in developing and implementing marketing plans to capture identified sales opportunities. Conduct on-site audits to assess and solve customer problems or meet customer requirements.
The Principal Compliance Specialist, Product Stewardship will ensure Edwards devices meet the material compliance requirements of global human health and environmental regulations. This role is an integral part of Edwards Product Stewardship Group, with a growing focus on sustainability and environmental initiatives. The Principal Compliance Specialist will serve as a subject matter expert across global regulation requirements, facilitate company-wide data analysis, expand global regulatory intelligence, and lead in a cross-functional role.
The primary purpose is to provide leadership and direction to assure that the assigned locations’ management staff and employee populations are knowledgeable and compliant in the applicable areas of Environmental Health & Safety. This position will champion projects, and activities to achieve location priorities and company values. Frequent travel to assigned locations is expected (around 50%).
The Quality Manager supports manufacturing and advises on vendor onboarding, technical transfer and validation. This role acts as a GMP/GDP advisor to the manufacturing and supply team for activities in the US and provides operational Quality support through QMS oversight and record management.