Senior Remote Orthopedic Supplier Quality Engineer

Zohorecruit; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

MB&A is a medical device quality, regulatory, and operations firm seeking a hands-on supplier quality engineer with real orthopedic experience. You will strengthen supplier qualification, monitoring, and controls within QMSR (21 CFR 820) and ISO 13485:2016 by reference.

The role evolves to include supplier audits and project leadership as the engagement grows. Responsibilities cover supplier selection, risk-based verification, quality agreements, SCARs, and trend analysis.

Qualifications

• Minimum 5 years of quality engineering in medical devices.
• Hands-on orthopedic implants and instruments experience.
• Supplier-facing duties: qualification, SCARs, supplier changes, incoming quality.
• Knowledge of QMSR & ISO 13485:2016, Chapter 7 purchasing/production controls.
• Ability to read engineering drawings, GD&T, material certs, FAI/FAIR packages.
• Strong written and verbal communication with leadership and suppliers.
• Willingness to travel up to 25% and work remotely.

Responsibilities

• Evaluate and select suppliers using documented criteria and risk-based controls.
• Monitor and re-evaluate suppliers; take action when requirements are not met.
• Maintain audit-ready supplier evaluation records and cleanup of approved list.
• Define purchasing information including specs, acceptance criteria, and QMS requirements.
• Draft and maintain quality agreements; ensure supplier-change notifications prior to implementation.
• Set appropriate verification level for purchased product based on risk.
• Review supplier process validations for machining, coatings, cleaning, passivation, sterilization.
• Ensure traceability records for implantable components and materials.
• Apply controls to outsourced processes and manage SCARs, root-cause, and CAPAs.
• Track supplier performance with scorecards and trend data for management reviews.
• Plan and perform supplier audits; participate in qualification, surveillance, and for-cause audits.
• Provide clear status updates to client leadership and flag risks early.

Skills

Quality engineering

Written communication

Verbal communication

Autonomy

Travel readiness

Reading drawings

Education

Bachelor's degree in engineering

Tools

QMSR & ISO 13485:2016

GD&T

F AI/FAIR packages

eQMS platforms

Job description

MB&A is a medical device quality, regulatory, and operations firm seeking a hands-on supplier quality engineer with real orthopedic experience. You will strengthen supplier qualification, monitoring, and controls within QMSR (21 CFR 820) and ISO 13485:2016 by reference.

The role evolves to include supplier audits and project leadership as the engagement grows. Responsibilities cover supplier selection, risk-based verification, quality agreements, SCARs, and trend analysis.