Remote Supplier Quality Engineer - Elevate Medical Device

SpiTrex Orthopedics; Plymouth (IN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Vision and dental coverage

401(k) with company match

Job summary

SpiTrex CTE is hiring a Supplier Quality Engineer to lead the supplier quality management program, drive audits, and coordinate corrective actions. You will partner with Procurement and internal teams to ensure compliance with ISO13485, 21 CFR Part 820, and contractual requirements.

A background in medical device quality is preferred and a 3–5 year track record in quality is expected. The role can be performed remotely with potential occasional site visits.

Qualifications

• AS in Engineering field preferred or minimum 2 years in Quality Engineering role.
• Medical Device manufacturing experience is preferred.
• 3–5 years of experience in quality setting preferred.

Responsibilities

• Lead supplier quality management program in line with quality systems and regulatory requirements.
• Develop and maintain processes for supplier qualification, approval, monitoring, and ongoing performance management.
• Conduct supplier risk assessments and mitigate based on capability, quality history, and business risk.
• Lead supplier qualification, onboarding, evaluation, and approval with Procurement and stakeholders.
• Plan and conduct supplier quality audits and assessments for compliance with standards and contractual requirements.
• Review supplier audits and coordinate corrective actions with suppliers and internal teams.
• Manage supplier corrective action requests (SCARs) and verify effectiveness.
• Investigate supplier-related quality concerns and coordinate containment and corrective actions.
• Provide technical guidance for supplier-related nonconformances and quality issues.
• Assess impacts of supplier changes on product quality and manufacturing.
• Collaborate with Quality and Engineering on validation and inspections related to supplier changes.
• Develop supplier scorecards and metrics for quality, delivery, and responsiveness.
• Analyze trends to identify recurring issues and improvement opportunities.
• Support cross-functional investigations and CAPA activities.
• Prepare supplier quality reports and management reviews.

Skills

Supplier quality

Analytical skills

Engineering drawings

Quality risks

Project management

Cross-functional collaboration

Communication

Attention to detail

MS Office & QMS

Education

AS in Engineering or Quality Eng experience

Tools

Quality management systems

MS Office

Job description

SpiTrex CTE is hiring a Supplier Quality Engineer to lead the supplier quality management program, drive audits, and coordinate corrective actions. You will partner with Procurement and internal teams to ensure compliance with ISO13485, 21 CFR Part 820, and contractual requirements.

A background in medical device quality is preferred and a 3–5 year track record in quality is expected. The role can be performed remotely with potential occasional site visits.