What are the responsibilities and job description for the Quality Management System Manager position at BioTalent?
Overview
A growing medical device company is seeking an experienced Quality leader to serve as both the on-site head of Quality at a primary manufacturing facility and the enterprise owner of the Quality Management System (QMS).
This role is responsible for ensuring a compliant, scalable, and harmonized QMS across multiple global locations, supporting regulatory requirements including ISO 13485, FDA QSR/QMSR, and EU MDR. The position plays a critical role in maintaining audit readiness, enabling operational excellence, and supporting expansion into new markets.
Reporting to the Head of Quality, this individual will lead site-level quality functions, oversee the corporate QMS, and act as a key liaison with regulatory authorities and notified bodies.
Key Responsibilities
Site Quality Leadership
- Lead all quality activities at the manufacturing site, including both daily operations and long-term strategy
- Manage and develop a cross-functional quality team (QA, Quality Engineering, QC/Lab, Document Control, Complaints)
- Oversee core quality processes such as incoming inspection, product release, nonconformance, and change control
- Establish and monitor key performance indicators (KPIs) and drive continuous improvement initiatives
- Exercise authority to halt production or shipments when quality risks are identified
Enterprise QMS Ownership
- Serve as global process owner for the Quality Management System across all sites
- Maintain and improve the Quality Manual, policies, and core procedures
- Ensure compliance with applicable regulatory standards (ISO 13485, FDA 21 CFR 820/QMSR, EU MDR)
- Lead internal audit programs and ensure readiness for external audits (FDA, notified bodies, MDSAP)
- Facilitate CAPA governance and management review processes
- Promote a risk-based, data-driven approach to quality and continuous improvement
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Quality, or a related discipline
- 10–15 years of progressive experience in Quality within a regulated industry (medical devices preferred; pharma/biotech considered)
- At least 5 years of direct responsibility for QMS leadership or ownership
- Demonstrated experience building and maintaining ISO 13485-compliant QMS in multi-site environments
- Strong track record leading audits and managing regulatory inspections and responses
- Experience with electronic QMS or document management systems preferred
Preferred Certifications
- ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)
- ISO 13485/9001 Lead Auditor
- Lean or Six Sigma certification
Additional
- Ability to travel (~15%)
- Multilingual skills (e.g., French) are a plus
Compensation & Benefits
- Salary range: $130,000 – $150,000
- Comprehensive medical, dental, and vision coverage
- 401(k) with employer match
- Life and AD&D insurance
- Generous paid time off and holiday schedule
- Parental leave benefits
Salary : $130,000 - $150,000