Senior Supplier Quality Engineer

Job Description

Job Description

Osteal Therapeutics is a Dallas-based, privately held biotechnology company redefining the standard of care for life-altering orthopedic infections.

Osteal is hiring to launch NEXCHANGE™ KIT, a first-of-its-kind FDA Breakthrough Therapy for periprosthetic joint infection (PJI), a critical condition impacting 50,000 Americans annually. PJI currently lacks FDA-approved therapies and forces patients through grueling, months-long treatments with poor outcomes. Our disruptive technology transforms this journey by safely delivering high-concentration, broad-spectrum antibiotics directly to the infection site; reducing the treatment timeline from months to just seven days.

Powered by $137M in funding to date and a distinguished investor base that includes strategic partners Johnson & Johnson and Zimmer Biomet, we are advancing toward FDA approval and building the organization that will bring this therapy to patients in dire need.

We are looking for bold, relentless professionals who thrive in a “builder” environment. If you are driven by the opportunity to do work that genuinely matters — to be part of a cohesive and capable team striving to deliver the first on-label PJI treatment that promises to transform outcomes for tens of thousands of patients.

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
• Certified Lead Auditor for ISO 13485 or equivalent quality auditing certification

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

Osteal Therapeutics is an Equal Opportunity Employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to protected characteristics such as race, color, religion, sex, national origin, age, disability, or veteran status.