Supplier Quality Engineer II

Midmark Corporation • Versailles, OH

1d

About The Position

JOB SUMMARY: This role involves maintaining and improving quality engineering methodologies. This role requires more experience in supplier audits, quality improvement plans, and problem-solving. A deeper understanding of medical device manufacturing and quality systems is required. Can perform duties without supervision. 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. Analyzes processes and contributes to improvements. Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes. Assists in the review and approval of supplier corrective action plans and assists in the investigation of any supplier-related complaints. Identifies and communicates risks, participates in issue resolution, and mentors junior engineers. Assists in identifying/evaluating risks and contributes to risk mitigation. Participate 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 mixed between custom engineered components and distributed/off the shelf components and OEM products and actively works with Global Sourcing in new supplier selection and qualification. Applies advanced engineering methods and tools to solve engineering problems. Identifies and contributes to process improvements utilizing six sigma techniques. May assist six sigma training at suppliers. SECONDARY DUTIES: Assists in developing and maintaining supplier quality improvement programs and metrics. Participates in either back room or front room in support of MDSAP (or equiv.) audits. Assists in internal audits.

Requirements

• Bachelor’s degree in engineering or related field and 2+ years of relevant experience, or equivalent experience.
• Effective communication with both internal and external stakeholders
• Working knowledge of FDA CFR 820 and ISO 13485
• Advanced analytical skills, ability to define and analyze complex problems

Nice To Haves

• Six Sigma Black Belt certification will be required in the role.

Responsibilities

• Conducts activities concerned with the quality assurance of a given commodity set by working closely with suppliers, manufacturing, purchasing, and supplier quality.
• Analyzes processes and contributes to improvements.
• Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes.
• Assists in the review and approval of supplier corrective action plans and assists in the investigation of any supplier-related complaints.
• Identifies and communicates risks, participates in issue resolution, and mentors junior engineers.
• Assists in identifying/evaluating risks and contributes to risk mitigation.
• Participate 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 mixed between custom engineered components and distributed/off the shelf components and OEM products and actively works with Global Sourcing in new supplier selection and qualification.
• Applies advanced engineering methods and tools to solve engineering problems.
• Identifies and contributes to process improvements utilizing six sigma techniques.
• May assist six sigma training at suppliers.
• Assists in developing and maintaining supplier quality improvement programs and metrics.
• Participates in either back room or front room in support of MDSAP (or equiv.) audits.
• Assists in internal audits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level