Manufacturing & Quality Engineer

Racine, WI

About the position

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.

Responsibilities

• 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.
• 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.
• 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.
• Assist in the validation of equipment and processes used in the production of medical devices, ensuring they meet regulatory and quality standards.
• 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.
• Support global engineering teams with conducting onsite inspections at supplier facilities to assess production processes, quality control measures, and compliance with regulatory requirements.
• Collaborate with the Production Manager to ensure seamless production processes, offering support and guidance where needed to resolve quality-related challenges.

Requirements

• Strong problem solving and root cause analysis skills.
• Attention to detail and excellent communication skills.
• Experience working in a regulated manufacturing environment.
• Understanding of ISO 13485 and 21 CFR Part 820 regulations and cGMP standards is an advantage.
• Experience with quality control tools, quality management systems, and equipment/process validation procedures.
• 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.

Nice-to-haves

• Experience in plastics manufacturing (Injection molding, blow molding, rotational molding etc…).
• Excellent communication and interpersonal skills to collaborate with internal/external teams & suppliers.