Quality Engineer

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Quality Full Time Hugo Benzing LLC, Wixom, MI, US

2 days ago Requisition

About the Role:

The Quality Engineer plays a critical role in ensuring that products and processes meet stringent quality standards and regulatory requirements, particularly within regulated industries such as medical devices. This position is responsible for developing, implementing, and maintaining quality systems that drive continuous improvement and compliance with ISO 13485 standards. The Quality Engineer will lead root-cause analysis efforts and corrective and preventive actions to resolve quality issues and prevent recurrence.

They will collaborate closely with suppliers and cross-functional teams to ensure that incoming materials and components meet quality expectations through first article inspections and ongoing supplier quality management. Ultimately, this role ensures that products are manufactured consistently to specification, enhancing customer satisfaction and minimizing risk to the organization.

Minimum Qualifications:

• Bachelor’s degree in Engineering, Quality Management, or a related technical field.
• Proven experience with Statistical Process Control (SPC) and Corrective and Preventive Actions (CAPA).
• Familiarity with ISO 13485 standards and quality system regulations.
• Experience conducting root-cause analysis and implementing effective quality solutions.
• Strong knowledge of supplier quality management and first article inspection processes.

Preferred Qualifications:

• Certification as a Quality Engineer (CQE) or equivalent.
• Experience with Geometric Dimensioning and Tolerancing (GD&T) in a manufacturing environment.
• Hands-on experience with control plan development and implementation.
• Background in medical device or highly regulated industries.
• Proficiency with quality management software and data analysis tools.

Responsibilities:

• Develop, implement, and maintain Statistical Process Control (SPC) methods to monitor and improve manufacturing processes.
• Lead Corrective and Preventive Actions (CAPA) investigations by performing root-cause analysis and driving resolution activities.
• Manage supplier quality by conducting audits, evaluating supplier performance, and coordinating first article inspections.
• Ensure compliance with ISO 13485 quality management system requirements and maintain documentation accordingly.
• Create and maintain control plans and geometric dimensioning and tolerancing (GD&T) documentation to support product quality and manufacturing consistency.

Skills:

The required skills such as Statistical Process Control and Corrective and Preventive Actions are applied daily to monitor production quality and address deviations proactively. Root-cause analytical skills enable the engineer to identify underlying issues and implement sustainable corrective measures. Supplier quality expertise ensures that all incoming materials meet stringent standards through first article inspections and ongoing supplier evaluations. Knowledge of ISO 13485 and quality systems guides the maintenance of compliant documentation and processes, ensuring regulatory adherence.

Additionally, skills in Geometric Dimensioning and Control Plan development support precise manufacturing and consistent product quality, fostering continuous improvement across operations.