Supplier Quality Engineer I

Midmark Corporation • Versailles, OH

4h

About The Position

An entry-level role responsible for assisting in the development and maintenance of quality engineering methodologies. Participates in supplier selection, audits, and quality improvement plans. Requires a basic understanding of medical device manufacturing and quality systems.

Requirements

• Bachelor's degree in engineering or related field, or equivalent work experience.
• Effective communication within the team and the ability to escalate issues when needed
• Basic understanding of FDA CFR 820 and ISO 13485
• Basic data collection and analysis skills to solve simple problems

Nice To Haves

• Six Sigma Green Belt certification preferred.

Responsibilities

• Conducts activities concerned with the quality assurance of a given commodity set by working closely with suppliers, manufacturing, purchasing, and supplier quality.
• Follows existing processes and learns about improvements.
• Collaborates with development team and more experienced engineers. Escalates significant issues or decisions to higher-level engineers.
• Assist in the review and approval of supplier corrective action plans and assist in the investigation of any supplier-related complaints.
• Implements solutions, identifies and raises project risks, and acts as a team contributor.
• Identifies potential risks, reports them, and collaborates with experienced engineers.
• Participates in new product development teams and component qualification process as needed to carry out approvals for given components.
• Conducts and documents regular visits/audits to assigned suppliers to review manufacturing processes, quality systems/controls, pre-launch readiness, root cause identification, corrective actions, and process improvement opportunities.
• Has a commodity focus that is largely distributed/off the shelf items and actively works with Global Sourcing in new supplier selection and qualification.
• Applies a foundational knowledge of engineering methods to perform assigned tasks within defined procedures. Learns and applies new engineering techniques through mentored experience.
• Participate in back room for MDSAP (or Equiv) audits.
• Assists with internal auditing as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees