Quality Systems Manager
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About you:
You are a detail-oriented quality professional with strong medical device experience and a track record of owning Quality Management Systems end to end. You're comfortable serving as the eQMS subject matter expert and business process owner, balancing compliance requirements with business objectives in a fast-paced product development and manufacturing environment. You bring strong leadership, stakeholder management, and analytical skills, and you're motivated to embed quality and compliance across R&D, Manufacturing, Operations, and Supply Chain.
What you'll do:
Own, maintain, and continuously improve the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA QMSR, MDSAP, Health Canada Medical Device Regulations, and other applicable global requirements.
Serve as business owner and administrator of the eQMS, configuring and optimizing workflows, forms, permissions, training curricula, and dashboards.
Lead eQMS implementations, upgrades, enhancements, and validation activities, partnering with IT and external vendors on system performance and compliance.
Plan and manage internal quality audits, and coordinate external audits, certification audits, customer audits, and regulatory inspections.
Oversee CAPA, deviation, nonconformance, and change control processes, ensuring effective root cause investigations and monitoring quality trends.
Lead Management Review activities, developing and maintaining quality dashboards and performance metrics for senior leadership.
Ensure effective document control processes, including creation, approval, revision, and archival of quality system documents and training records.
Support product development activities in accordance with design control requirements, including design reviews, verification, validation, and design transfer.
Ensure risk management activities are conducted in accordance with ISO 14971 and review product/process changes for quality and regulatory impact.
Support supplier qualification, monitoring, audits, and corrective action programs.
Support complaint handling, investigations, and post-market surveillance activities, including trending and regulatory reporting as required.
Identify and lead quality improvement initiatives across the organization, applying risk-based decision making.
What you'll need:
Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Quality, or a related technical discipline.
Minimum 7 years of experience in Quality Assurance or Quality Systems within a regulated medical device environment.
Minimum 3 years of experience managing or leading Quality Systems.
Demonstrated experience maintaining and improving ISO 13485-certified Quality Management Systems.
Demonstrated experience administering, maintaining, and optimizing electronic Quality Management Systems (eQMS).
Experience leading eQMS implementations, upgrades, migrations, validations, or process harmonization projects.
Experience supporting FDA inspections, MDSAP audits, ISO 13485 certification audits, and customer audits.
Experience supporting product development, design controls, verification, validation, and commercialization activities.
Strong knowledge of ISO 13485, FDA QMSR, MDSAP, Health Canada Medical Device Regulations, ISO 14971, CAPA/root cause methodologies, supplier quality management, internal/external auditing, document control, CSV, and data integrity principles (ALCOA+).
Bonus points for:
Diagnostics, IVD, point-of-care diagnostics, molecular diagnostics, or laboratory instrumentation experience.
Master's degree.
Experience with MasterControl, Greenlight Guru, Veeva, ETQ Reliance, TrackWise, Arena QMS, or equivalent regulated eQMS platforms.
ASQ Certified Quality Auditor (CQA), ASQ CMQ/OE, ISO 13485 Lead Auditor, Lean Six Sigma, or Regulatory Affairs Certification (RAC).
Why join us:
At Vital Bio, you will:
Help bring innovative medical technology to life and make a real impact on how healthcare is delivered.
You will work across disciplines to turn ambitious ideas into manufacturable products, with the opportunity to shape how we launch, scale, and improve them.
If you want to build something meaningful with a team that values trust, agility, and ownership, this is the place for you.
The compensation range for this role is $110,000 - $145,000.
Compensation will be determined based on the individual's demonstrated experience, education, training, relevant certifications or licensur