Quality Specialist

Quality Specialist

CONTEXT & INITIATIVE DESCRIPTION

Our innovative Global Medical Device Client is seeking a Quality Specialist to support their Biological Safety team . This position is responsible for reviewing, revising, and strengthening cleaning validation programs for surgical instruments used in spine medical devices. The Quality Specialist will leverage strong technical expertise in cleaning validation, ISO 19227, and FDA/MDR regulations to ensure robust and compliant processes during manufacturing and vendor transfers. In performing these responsibilities, this role will work closely with business leaders, quality, regulatory, and vendor partners to assess current programs, revise acceptance criteria, and implement consistent monitoring processes that meet global regulatory expectations without invalidating existing biological safety work.

DUTIES / EXPECTATIONS OF THIS ROLE .

• Review current cleaning validation program and provide expertise in ISO 19227 and FDA/MDR expectations .
• Authorize and revise procedures, protocols, and reports; justify adjustments to acceptance criteria using risk-based, science-driven rationale.
• Conduct risk assessments and determine appropriate validation endpoints (TOC, NVR, particulates, endotoxin).
• Develop and implement monitoring programs in collaboration with external vendors, ensuring consistency across suppliers.
• Partner cross-functionally with Quality, Regulatory, Manufacturing, and Biological Safety functions to align validation strategy.
• Ensure all documentation meets regulatory and audit readiness standards, supporting EU MDR and FDA requirements.
• Provide guidance and mentorship to internal engineers on cleaning validation best practices.
• Act as primary SME in discussions with auditors or regulators regarding cleaning validations.

MUST HAVES – QUALIFICATION SUMMARY

• Bachelor’s degree in Engineering, Chemistry, or related scientific discipline.
• Medical Device experience is mandatory (minimum 2–5 years; preference for 8–10+ years).
• Direct expertise in cleaning validation for instruments in a regulated environment.
• Strong knowledge of ISO 19227, FDA, and MDR regulatory frameworks .
• Proven ability to conduct risk assessments, establish acceptance criteria, and defend decisions to auditors/regulators.
• Excellent communication skills with the ability to present complex technical rationales clearly to cross-functional stakeholders.

NICE-TO-HAVES

• Chemistry background or experience with characterization of residues/contaminants.

• Supplier/vendor management experience.

TRAVEL & LOCATION

• Onsite in Westminster, CO (Hybrid)

• Travel to different sites occasionally.

START & TERM

• Full time permanent
• Immediate start