JOB REQUIREMENTS: We are looking for a strong problem solving and root cause analysis skills, attention to detail and communication skills. You will have experience working in a regulated manufacturing environment. You will be capable of independently driving the closure of issues and projects, using the support of the whole team. Understanding of ISO 13485 and 21 CFR Part 820 regulations and cGMP standards is an advantage. The Manufacturing & Quality Engineer plays a critical role in ensuring exceptional quality standards across supply chain and production processes. This role is focused on implementing advanced problem-solving methods, performing root cause analysis, and driving corrective and preventive actions (CAPAs) to resolve non-conformities effectively. This role has significant growth potential and provides the opportunity to work on a variety of interesting projects outside of the core responsibilities of the role. Key Responsibilities * Root Cause Analysis & Problem Solving * Perform thorough root cause analysis for quality-related issues using structured problem-solving tools * Develop and implement corrective and preventive action (CAPA) plans, ensuring resolution effectiveness. * Identify process inefficiencies and recommend improvements to mitigate recurrence of issues. * Continuous Improvement Initiatives * Collaborate with cross-functional teams to identify and implement process, product and systems improvements. * Gather, summarize and leverage data and trend analysis to identify areas for improvement * Quality Control * Monitor and document non-conformities in products, processes, or services. * Lead investigations for complaints, ensuring stakeholder resolution. * Innovate detection methods to proactively address new quality challenges. * Validation of Equipment/Processes * Assist in the validation of equipment and processes used in the production of medical devices, ensuring they meet regulatory and quality standards. * Liaise with suppliers * Act as the primary point of contact between the company and suppliers, fostering positive relationships and ensuring clear communication channels. * Collaborate with suppliers to address quality issues, implement corrective actions, and facilitate continuous improvement initiatives. * Supplier onsite inspection & audits * Support global engineering teams with conducting onsite inspections at supplier facilities to assess production processes, quality control measures, and compliance with regulatory requirements * Support Production team * Collaborate with the Production Manager to ensure seamless production processes, offering support and guidance where needed to resolve quality-related challenges. Skills and Qualifications * Experience with quality control tools, quality management systems, and equipment/process validation procedures * Experience in plastics manufacturing is desirable (Injection molding, blow molding, rotational molding etc...) * Excellent communication and interpersonal skills to collaborate with internal / external teams & suppliers. * Strong attention to detail and ability to identify subtle defects or discrepancies. * Problem-solving skills and a proactive approach to addressing issues. * Experience in medical device field and quality management standard such as ISO 13485 and/ or 21 CFR Part 820 is highly desirable. * Familiarity with quality management systems (QMS) software and experience in utilizing such software to record inspection records and non-conformities. Learn more about us and our mission! Daniels Health & Sharpsmart is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Daniels Health & Sharpsmart prohibit discrimination and harassment of any type and a To view the full job description please use the link below. https://www.aplitrak.com/?adid=YmJ ZW5lcmljLjc3NjAwLjg3NzBAZGFuaWVsc2hlYWx0aGNvbXAuYXBsaXRyYWsuY29t ***** APPLICATION INSTRUCTIONS: Apply In Person: 1340 Grandview PKWY Sturtevant, WI 53177 Apply Online: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjc3NjAwLjg3NzBAZGFuaWVsc2hlYWx0aGNvbXAuYXBsaXRyYWsuY29t