Quality assurance lead
location: burlington, on
company: vb spine
looking for a career where your work truly matters? At vb spine, you'll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We're the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a quality assurance lead in our quality assurance function within the spine division, you'll serve as the primary quality leader at an international distribution center-ensuring full compliance with global regulatory standards, corporate quality systems, and gxp requirements while driving quality oversight, risk management, and continuous improvement to support safe and effective product distribution outside the united states.
What you’ll do:
act as the primary quality liaison with the vb spine corporate quality team, cross-functional partners (operations, regulatory, sales, marketing), and international health authorities / notified bodies
provide leadership and oversight of the site quality management system, including complaints handling, post-market surveillance reporting, nonconformances (ncs), capas, deviations, change control, product holds/recalls, and gxp documentation
lead timely investigations, root cause analysis, effectiveness checks, and documentation for quality events
develop, update, and maintain site procedures in mastercontrol (including support for local language translations where applicable) and ensure alignment with global/regional policies and governance
oversee distribution and storage quality, product traceability, lot control, supplier management (onboarding, audits, trending/scoring), validation (equipment, process, software including uat), preventive maintenance, calibration, and gage programs
serve as the lead for distribution site audits, quality interactions with authorities, and conduct internal audits
prepare and present quality reports, distribution metrics, site-level quality data, trends, and risk escalations to leadership and support management review activities
drive process improvement projects, ensure training compliance across gxp teams, and maintain adequate resourcing and capability
escalate significant quality risks and contribute to continuous improvement initiatives
what you bring:
bachelor's degree in science or equivalent required
minimum 5 years of quality assurance or related experience in a regulated industry (medical device, pharmaceutical, or healthcare preferred)
applied knowledge of international regulations, including but not limited to: health canada regulations, european medical device regulation (mdr), medical device directive (mdd), iso 13485, fda quality system regulation, and related gxp standards
iso 13485 or iso 9001 lead auditor certification is a strong advantage
familiarity with electronic quality systems (e.g., trackwise digital for nc/capa) and erp systems (e.g., jd edwards)
strong knowledge of quality concepts including risk management, capa, audits, statistics, and gmp compliance for medical devices
experience with regulation or products associated with human cells, tissues, and organs is a plus
proficient in microsoft office suite, document control systems, erp, and statistical software (minitab preferred)
excellent written and verbal communication skills; able to present data, kpis, and quality information effectively to all organizational levels
highly organized with strong time management, detail orientation, initiative, resourcefulness, creative problem-solving, and adaptability
self-motivated, able to multi-task, follow procedures rigorously, and maintain high quality standards at all times
physical ability to stand, walk, sit, reach, use hands/tools, talk/hear, and occasionally lift up to 30 pounds; requires good vision (close, distance, color, peripheral, depth perception, and focus adjustment)
why vb spine?
We believe in growing talent from within. At vb spine, join a high-performing team, benefit from peer and executive mentorship, and lead quality excellence in international markets-directly supporting safe, compliant distribution of innovative spinal solutions that improve patient lives worldwide.
Compensation:
pay for this role is competitive and based on experience, qualifications, regional market conditions, and performance. The typical pay range for this position will align with senior quality leadership roles in the relevant international market, 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, regulatory expertise, language proficiency, and local economic factors.
Benefits include:
comprehensive health, dental, and vision insurance (tailored to local market)
retirement savings plan with company match (where applicable)
paid time off (pto), holidays, and local leave entitlements
ongoing training and professional development opportunities
opportunity to grow within a fast-paced, dynamic, global company
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