Senior Supplier Quality Engineer

TL;DR

Senior Supplier Quality Engineer: Ensuring supplier-provided materials, components, and services meet quality, reliability, and regulatory requirements for new product launches with an accent on risk-based supplier qualification, audits, and lifecycle performance management. Focus on driving CAPA, corrective actions, and continuous improvement across the supply base to support robust supplier readiness for NPD programs.

Location: Lafayette, CO (Onsite)

Salary: $99,200 - $148,800 (USD)

Company

hirify.global develops medical technologies and therapies to alleviate pain, restore health, and extend life.

What you will do

• Lead supplier quality initiatives for materials, components, and services to meet hirify.global quality, regulatory, and business requirements.
• Drive supplier qualification, selection, approval, and supplier development activities, including supplier certification programs.
• Monitor and evaluate supplier performance across the product lifecycle and resolve supplier quality issues with sustainable CAPA.
• Develop and execute risk-based supplier audit plans to ensure compliance with GMP, quality management systems, and global regulatory requirements.
• Serve as Supplier Quality Engineering lead for NPD programs supporting regional expansions, design changes, and supplier development.
• Define receiving inspection requirements and support verification/validation activities for supplier-provided components and materials.

Requirements

• Bachelor’s degree in Engineering or a technical field with at least 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.
• Experience supporting supplier qualification, supplier audits, supplier development, and supplier performance management in a regulated industry.
• Knowledge of quality management systems and regulatory requirements, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and GMP.
• Experience supporting NPD activities, including design controls, risk management, process validation, and control plan development.
• Proficiency with quality engineering tools and methodologies such as CAPA, root cause analysis, statistical techniques, and FMEA.
• Ability to conduct supplier assessments/audits and drive corrective actions.

Nice to have

• ASQ certification (CQE, CSQP) and/or Lean Six Sigma Green Belt or Black Belt certification.

Culture & Benefits

• Onsite work schedule: 4 days per week onsite.
• Eligible for a short-term incentive (hirify.global Incentive Plan, MIP).
• Health, dental, and vision insurance plus Health Savings Account and Healthcare Flexible Spending Account.
• 401(k) plan with employer contribution and match, paid time off, and paid holidays.
• Tuition assistance/reimbursement and global well-being program (Simple Steps).

Hiring process

• Application review followed by interviews to assess supplier quality and regulatory experience.
• Final steps include work authorization and onboarding requirements.