Senior Supplier Quality Engineer

Osteal Therapeutics•Dallas, TX

2d•$120,000 - $130,000•Onsite

About The Position

Osteal Therapeutics is a Dallas-based, privately held biotechnology company redefining the standard of care for life-altering orthopedic infections. At the heart of our pipeline is NEXCHANGE™ KIT, a first-of-its-kind FDA-designated Breakthrough Therapy for periprosthetic joint infection (PJI) — a devastating condition that strikes 50,000 Americans each year. Once diagnosed, PJI patients face a dramatically diminished quality of life, the threat of amputation, and a five-year survival rate worse than that of melanoma. Today, they must navigate a grueling, month-long treatment journey with no FDA-approved therapy and uncertain outcomes. NEXCHANGE KIT fundamentally changes the patient journey by reducing the treatment time from months to seven days. It replaces uncertainty with a defined protocol, enabled by the safe delivery of broad-spectrum antibiotics directly to the site of infection at sustained concentrations up to 1,000 times higher than standard systemic therapies. With NEXCHANGE KIT, Osteal is not simply launching a product. We are creating an entirely new therapeutic category. 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 — there has never been a better moment to join Osteal Therapeutics. 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.

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

Nice To Haves

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
Experience supporting clinical-stage to commercial-stage product transitions preferred

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.