The Manufacturing Quality Engineer is a hands-on engineering professional responsible for ensuring that all products, including hardware and software, meet or exceed the quality expectations and requirements of both internal and external customers. They support the transfer of new product designs from Engineering to Manufacturing and support day-to-day manufacturing operations. Additionally, the Manufacturing Quality Engineer supports the adherence to quality standards for manufacturing.
Key Areas of Responsibility:
• Work collaboratively with cross-functional teams to develop robust, error-proofed, and efficient manufacturing processes.
• Conduct time studies to aid in tracking product labor cost, line balancing, and productivity.
• Lead pre-production build activity and oversee the design transition into full production.
• Facilitates the design and fabrication of basic tooling and fixtures to aid in manufacturing.
• Create clear and concise work instructions, test instructions, detailed reports, and other documentation as required.
• Assist in training Production Associates when requested.
• Support Manufacturing Operations and help ensure daily production targets and metrics are met.
• Assist in troubleshooting production, customer returns and calibrated equipment failures and help perform root cause analyses and corrective action.
• Initiate Engineering Change Requests (ECRs) and Engineering Change Notices (ECNs)
• Work with the Engineering and Manufacturing Operations groups on resolving supplier quality issues.
• Support the development of a safe, ergonomic, and environmentally sound workplace.
• Able to lead small teams in problem solving sessions or lean/kaizen events.
Knowledge, Skills & Abilities:
• BS or higher degree in Mechanical, Electrical, Industrial Engineering, or related technical discipline.
• Minimum 2-4 years of related experience.
• Experience with Microsoft Dynamics 365 or similar ERP systems preferred.
• Experience with Lean Manufacturing and use of Six Sigma tools and methodologies.
• Experience writing clear and concise work Instructions for the Production personnel to use to properly build products.
• Demonstrates a continuous improvement mindset with a proactive approach to problem solving and collaboration.
• Proficiency with Microsoft Office required; experience with Visio, AutoCAD, or SolidWorks is a plus.
• Demonstrated flexibility, self-direction, and self-discipline in planning and accomplishing objectives and in meeting deadlines with limited supervision.
• Must have excellent problem-solving skills and possess good analytical, verbal, and written communication skills.
• Ability to read and interpret mechanical drawings.
• Experience working in regulated industries such as medical devices, healthcare technology, or ISO-certified manufacturing environments preferred
