Quality Specialist - Medical Device Manufacturer

With ISO 13485 certification and a global footprint spanning nearly 50 countries, the organization offers the opportunity to contribute to life-changing products that positively impact patients worldwide. As the company continues to expand, they are launching an innovative new product line and are seeking professionals who can support key quality, compliance, and continuous improvement initiatives.

Product Review & Release

• Review Device History Records (DHRs), manufacturing documentation, inspection data, and quality records to confirm products meet release requirements.
• Perform final quality review and disposition of production lots in accordance with established procedures and regulatory standards.
• Verify completion of all required manufacturing, testing, inspection, and labeling activities before product release.
• Identify and escalate quality concerns, deviations, or nonconformances that could affect product acceptance or release decisions.
• Support investigations and corrective actions related to product release issues.

Complaint Management & Investigation

• Review, document, and process customer complaints in compliance with established quality and regulatory procedures.
• Assess complaints for completeness, risk level, investigation needs, and potential regulatory reporting requirements.
• Participate in complaint investigations to determine root cause and recommend corrective actions when necessary.
• Analyze complaint trends and performance data to identify recurring issues and emerging quality concerns.
• Escalate significant quality events and potentially reportable issues to Quality and Regulatory teams.
• Maintain accurate, complete, and compliant complaint documentation and records.

Internal & Supplier Audits

• Conduct internal and supplier audits in accordance with approved audit schedules and procedures.
• Evaluate quality management system processes for compliance with ISO 13485, ISO 14971, FDA requirements, and internal standards.
• Document audit observations, findings, and opportunities for continuous improvement.
• Verify implementation and effectiveness of corrective actions resulting from audit findings.
• Support audit readiness initiatives, regulatory inspections, and ongoing compliance activities.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Opportunity to have an impact on people's livesBonus Eligible!

• Bachelor's Degree (Engineering-related preferred)
• 2+ years of manufacturing experience within quality
• Understanding of ISO 9001
• Experience with electro-mechanical processes is preferred
• Medical device experience
• Combination device experience is preferred
• Experience working with capital equipment
• Experience working with sterile products is preferred
• Understanding of ISO 14971 and UL 60601 is preferred
• CQE certification is preferred
• Six Sigma belt is preferred
• Sponsorship is not provided

Our client is a well-established medical device manufacturer specializing in advanced electro-mechanical technologies and products. As the company continues to expand, they are launching an innovative new product line and are seeking professionals who can support key quality, compliance, and continuous improvement initiatives. With ISO 13485 certification and a global footprint spanning nearly 50 countries, the organization offers the opportunity to contribute to life-changing products that positively impact patients worldwide.

• Base salary between $60k-$80k
• Health, dental, vision
• 401(k) matching
• 3 weeks PTO
• 4% annual bonus incentive