Quality Assurance Specialist

About the role

As a Quality Assurance Specialist in our Operations Quality function within the Spine division, you'll play a key role in ensuring operational activities — including microbiological testing, inspections, manufacturing, and document review — meet established quality standards, regulatory requirements, and internal policies while driving continuous improvement.

Responsibilities

• Develop and review Quality and Operational documents, including SOPs, manufacturing records, test reports, and inspection records
• Coordinate routine microbiological testing (in-process and finished product) to verify compliance with specifications
• Coordinate and maintain purchasing controls and supplier quality agreements to support quality system compliance
• Assist in investigations for non-conforming products
• Support internal and external audits by providing documentation, responding to findings, and assisting with corrective actions
• Participate in change control activities and processes
• Collaborate closely with Production/Operations, QC, Regulatory Affairs, R&D, and Supply Chain to embed quality considerations throughout the product lifecycle
• Assist or lead continuous improvement initiatives in operations
• Perform inspections of incoming materials, in-process stages, and final products as needed
• Support Quality Awareness Tests and Process Improvement Reviews
• Interface with suppliers and support requests for internal and external manufacturing document management

Requirements

• Bachelor's degree in a science or related discipline
• Minimum 2 years of experience in a manufacturing setting
• Strong knowledge of U.S. and international medical device regulations
• Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Strong interpersonal, written, and oral communication skills with negotiation capability
• Analytical and problem-solving skills with demonstrated ability to work cross-functionally
• Ability to work independently, plan, and prioritize with minimal supervision
• Proficiency in Microsoft Office Suite, ERP systems, and Document Control software
• Strong decision-making, organizational, and detail-oriented skills

Qualifications

• Ability to read mechanical blueprints and familiarity with ANSI Y14.5 Geometric Tolerancing preferred
• Basic understanding of machining processes

Benefits

• Comprehensive health, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO) and holidays
• Ongoing training and professional development opportunities
• Opportunity to grow within a fast-paced, dynamic company

Pay

Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $75,000.00 - $90,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, skillset, and market conditions.