Job Description

About The Role

As the Senior Supplier Quality Engineer, you will be responsible for ensuring external suppliers consistently meet Osteal’s quality, regulatory, and operational expectations in support of combination product development and future commercial readiness.

A successful candidate is:

Strong technical quality professional who combines regulatory depth with practical supplier management experience.

Thrives in environments where collaboration, independent judgment, and decisive action are required.

Comfortable balancing technical rigor with business urgency and can effectively influence both internal teams and external manufacturing partners.

Brings a proactive mindset, strong communication skills, and the ability to drive accountability across complex supplier relationships.

Energized by building scalable quality systems in a growing organization and enjoy solving challenging quality and compliance issues that directly impact patient safety.

Responsibilities

Lead supplier qualification, onboarding, and lifecycle management activities for critical suppliers supporting Osteal’s orthopedic combination product portfolio, ensuring supplier controls are appropriately scaled based on risk, product criticality, and regulatory impact.
Drive supplier quality oversight across outsourced manufacturing operations, partnering closely with CMO/CDMOs and external manufacturing partners to ensure compliance with Osteal quality requirements, quality agreements, and applicable regulatory expectations.
Conduct supplier audits, qualification assessments, surveillance audits, GMP audits, and for-cause investigations to evaluate supplier compliance with ISO 13485, FDA QMSR, 21 CFR Part 4, 21 CFR Parts 210/211, and internal quality system requirements.
Serve as the primary quality liaison for supplier-related quality engineering matters, including nonconformances, investigations, deviation escalations, material review decisions, and supplier performance concerns.
Lead supplier corrective action (SCAR) activities, partnering with suppliers to drive robust root cause investigations, effective containment actions, and sustainable corrective/preventive actions.
Support cross-functional root cause investigations involving supplier-related product quality issues, complaint escalations, manufacturing deviations, and supply disruptions.
Review and assess supplier-initiated changes; including material, process, equipment, site, sterilization, packaging, analytical, and subcontractor changes, to determine quality, validation, and regulatory impact.
Ensure supplier quality agreements clearly define responsibilities related to change notification, deviation reporting, documentation requirements, complaint support, audit access, batch record expectations, and traceability obligations.
Develop and maintain supplier performance monitoring programs using quality metrics and risk indicators, including defect trends, audit outcomes, SCAR responsiveness, change control compliance, complaint linkage, and delivery quality performance.
Provide quality oversight of supplier validation and qualification activities where applicable, including sterilization validation, packaging validation, analytical method qualification, and manufacturing process controls.
Partner with Supply Chain and operations, Regulatory Affairs, Product Development, Manufacturing, and Quality leadership to proactively identify and mitigate supplier quality risks.
Support organizational inspection readiness by ensuring supplier oversight processes, documentation, and external quality controls align with FDA expectations and commercialization requirements.

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Quality, Pharmaceutical Sciences, Life Sciences, or related technical discipline
Minimum 8+ years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or related quality roles within regulated industries
Minimum 5+ years of experience in medical device, pharmaceutical, sterile manufacturing, or combination product environments
Demonstrated experience managing supplier quality in outsourced manufacturing models, including contract manufacturers and/or CDMOs
Hands-on experience conducting supplier audits and supplier qualification assessments
Strong working knowledge of ISO 13485, FDA QMSR, 21 CFR Part 4, 21 CFR Parts 210/211, supplier quality systems, CAPA/SCAR processes, supplier risk management, quality agreements, change control, and validation oversight
Preferred Qualifications
Direct combination product experience strongly preferred
Experience supporting orthopedic, musculoskeletal, implantable, sterile, or infection-related products
Experience working with CDMOs, sterile processing vendors, and pharmaceutical manufacturing partners
Knowledge of ISO 14971, ICH Q9, and ICH Q10
ASQ certification (CQE, CQA) or Lead Auditor certification preferred

Our Benefits

100% of Health Insurance paid by OstealTx for Employee & Dependents
Dental & Vision Insurance
Short & Long Term Disability Insurance paid 100% by OstealTx
401k (Regular & Roth)
Holiday Pay & PTO
Competitive compensation: Base ($115,000 - $130,000) + Bonus + Equity