Supplier Quality Engineer I
About The Position
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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
