Job Description

JOB SUMMARY:

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.

ESSENTIAL/PRIMARY DUTIES:

  • 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.

    • SECONDARY DUTIES:

  • Participate in back room for MDSAP (or Equiv) audits.
  • Assists with internal auditing as needed.

    • EDUCATION and/or EXPERIENCE:

    Bachelor's degree in engineering or related field, or equivalent work experience. Six Sigma Green Belt certification preferred.

    COMPETENCY and/or SKILL:

  • Effective communication within the team and the ability to escalate issues when needed
  • Basic understanding of FDA CFR and ISO
  • Basic data collection and analysis skills to solve simple problems

    • SUPERVISORY RESPONSIBILITIES:

  • May provide leadership, coaching, and/or mentoring to co-ops.

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