IMA Group is a global leader in the development and production of automatic machines for the processing and packaging of pharmaceutical, cosmetics, food, tea and coffee products. We are constantly oriented towards innovation, thanks to significant investments in R&D and a constant dialogue with customers, the territory and local suppliers. We promote an environmentally friendly attitude towards achieving sustainable development. Our history is characterized by a constant growth, realized also with the continuous investment on the development of people and their skills.
We are over 7,000 employees, 59% in Italy and 41% in the rest of the world, present in more than 80 countries.
IMA Life North America is a company within the IMA Group that specialises in providing aseptic processing and freeze-drying solutions for the pharmaceutical and biotechnology industries. IMA Life North America is part of IMA Life, a business unit focusing on the pharmaceutical sector who delivers advanced technologies for filling, lyophilisation and isolation, ensuring maximum sterility and product integrity for customers around the globe.
We are seeking a proactive, analytical Quality Engineer to drive continuous improvement and systemic quality excellence within a complex manufacturing environment. This role goes beyond standard compliance; it requires a hands-on problem solver who leverages Lean methodologies and data-driven frameworks to eliminate root causes, streamline processes, and elevate our Quality Management System.
PRIMARY POSITION RESPONSIBILITIES:
1. Advanced Non-Conformance & CAPA Management: Lead the rapid disposition and closure of product and material non-conformances. Utilize standardized troubleshooting frameworks (DMAIC, Ishikawa, 5 Whys) to drive definitive root cause analysis and implement sustainable corrective actions that permanently reduce costs and defects.
2. QMS & ISO 9001 Leadership: Provide robust oversight of the ISO 9001 Quality Management System. Act as a primary driver for internal and external audit management, system maintenance, and the rigorous enforcement of quality standards.
3. Lean & Process Optimization: Champion Lean methodologies to eliminate waste, improve process velocity, and optimize inspection workflows. Utilize visual scoreboards and data reporting to track KPIs and drive continuous flow.
4. Inspection & Verification Execution: Conduct incoming, Work-in-Process (WIP), and final product inspections. Ensure strict adherence to mechanical specifications for small and large metal fabrications, machined parts, and ASME-coded pressure vessels.
5. Supplier Quality Integration: Conduct supplier assessments and source inspections (some travel required). Partner extensively with suppliers to resolve chronic performance issues, educating them on critical product requirements and advanced quality control.
6. Metrology & Standardization: Oversee calibration of equipment. Generate, maintain, and refine standardized work instructions for inspection and calibration processes.
7. Safety & Compliance: Actively promote a culture of health and safety for all personnel and equipment users, ensuring strict daily compliance with all company and regulatory safety standards.
IMA IS AN EQUAL OPPORTUNITY EMPLOYER.
Established in 1961, IMA is world leader in the design and manufacture of automatic machines for the processing and packaging of pharmaceuticals, cosmetics, food, tea and coffee products, among others.
IMA’s mission is to invest in technologies that will improve the quality of life on the planet, reduce food waste, increase access to more effective drugs and allow greater respect for the environment.
Its position of leadership is the result of significant investments in R&D, regular and constructive dialogue with the end-users in its sectors and the Group's ability to expand internationally, conquering new markets.
The Group, whose Chairman is Alberto Vacchi, has more than 6,900 employees, more than 2,600 of whom overseas, and is present in about 80 countries, supported by a sales network made up of 30 branches (Italy, France, Switzerland, the United Kingdom, Germany, Austria, Spain, Poland, Israel, Russia, the United States, India, China, Malaysia, Thailand and Brazil), representative offices in central-eastern Europe and more than 140 agencies.
The Group has 54 production plants in Italy, Germany, France, Switzerland, Spain, the UK, the USA, India, Malaysia, China and Argentina.
The IMA Group owns more than 1,700 patents and patent applications in the world; over 500 designers are committed to product innovation. IMA has launched many new machine models over the last years.
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