Fasikl
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Base pay range
$100,000.00/yr - $150,000.00/yr Direct message the job poster from Fasikl Strategic Human Resources Leader | Empowering Employee Excellence | Elevating Business Performance and Culture
This is an on-site position in Bloomington, MN Fasikl Inc. is an innovative medical technology company developing AI-driven neuromodulation solutions. Our lead product, the
Felix NeuroAI Wristband,
is FDA-cleared to aid in the management of functional limitations due to essential tremor. We are seeking an experienced and driven
Manager of Quality Assurance
to lead and evolve our quality systems across both
pre-market
and
post-market
phases. This role will be instrumental in ensuring that our devices meet the highest standards of safety, compliance, and performance as we scale development, manufacturing, and global commercialization. Responsibilities
Pre-Market Quality Responsibilities Develop, implement, and maintain
design controls , risk management (ISO 14971), and product development documentation in accordance with 21 CFR 820 and ISO 13485. Ensure effective design transfer to manufacturing and supplier quality oversight. Support clinical and regulatory teams with quality documentation for FDA, CE, and other submissions. Manage quality inputs during product development, including verification/validation protocols, usability studies, and labeling reviews. Post-Market Quality Responsibilities Oversee
complaint handling , investigation, and Medical Device Reporting (MDR). Manage
CAPA
processes, including root cause analysis and effectiveness checks. Lead
post-market surveillance
activities, including trend analysis and risk re-evaluation. Support audits and regulatory inspections by FDA, Notified Bodies, or other agencies. General Quality System Management Maintain and improve the company’s
Quality Management System (QMS) . Lead
internal audits
and train teams on quality procedures and compliance culture. Evaluate and implement
eQMS tools
for scalable documentation control and traceability. Collaborate cross-functionally with R&D, clinical, operations, and regulatory teams. Qualifications
Bachelor’s degree in engineering, life sciences, or a related field (Master’s preferred) 5+ years experience in medical device quality assurance (experience in similar devices a plus) In-depth knowledge of
21 CFR 820, ISO 13485, ISO 14971 Strong understanding of both
design controls
and
post-market quality systems Experience preparing for or participating in
FDA inspections or ISO audits Familiarity with
eQMS platforms
(e.g., Greenlight Guru, MasterControl, Veeva) Excellent project management and communication skills Passion for innovation, compliance, and patient impact Desire to work in a dynamic, fast-paced environment. Maintain a strong commitment to ethics, professionalism, and integrity in all interactions. Commitment to Fasikl’s mission of improving lives through cutting-edge neuro-AI technology and exceptional patient care. Why Join Fasikl
Be part of a mission-driven team pioneering a new era of
AI therapeutics Contribute to the launch and scale-up of a
first-in-class FDA-cleared product Work in a fast-paced, supportive startup environment with real patient impact Competitive compensation, equity, and benefits Job details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Medical Equipment Manufacturing Referrals increase your chances of interviewing at Fasikl by 2x We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
$100,000.00/yr - $150,000.00/yr Direct message the job poster from Fasikl Strategic Human Resources Leader | Empowering Employee Excellence | Elevating Business Performance and Culture
This is an on-site position in Bloomington, MN Fasikl Inc. is an innovative medical technology company developing AI-driven neuromodulation solutions. Our lead product, the
Felix NeuroAI Wristband,
is FDA-cleared to aid in the management of functional limitations due to essential tremor. We are seeking an experienced and driven
Manager of Quality Assurance
to lead and evolve our quality systems across both
pre-market
and
post-market
phases. This role will be instrumental in ensuring that our devices meet the highest standards of safety, compliance, and performance as we scale development, manufacturing, and global commercialization. Responsibilities
Pre-Market Quality Responsibilities Develop, implement, and maintain
design controls , risk management (ISO 14971), and product development documentation in accordance with 21 CFR 820 and ISO 13485. Ensure effective design transfer to manufacturing and supplier quality oversight. Support clinical and regulatory teams with quality documentation for FDA, CE, and other submissions. Manage quality inputs during product development, including verification/validation protocols, usability studies, and labeling reviews. Post-Market Quality Responsibilities Oversee
complaint handling , investigation, and Medical Device Reporting (MDR). Manage
CAPA
processes, including root cause analysis and effectiveness checks. Lead
post-market surveillance
activities, including trend analysis and risk re-evaluation. Support audits and regulatory inspections by FDA, Notified Bodies, or other agencies. General Quality System Management Maintain and improve the company’s
Quality Management System (QMS) . Lead
internal audits
and train teams on quality procedures and compliance culture. Evaluate and implement
eQMS tools
for scalable documentation control and traceability. Collaborate cross-functionally with R&D, clinical, operations, and regulatory teams. Qualifications
Bachelor’s degree in engineering, life sciences, or a related field (Master’s preferred) 5+ years experience in medical device quality assurance (experience in similar devices a plus) In-depth knowledge of
21 CFR 820, ISO 13485, ISO 14971 Strong understanding of both
design controls
and
post-market quality systems Experience preparing for or participating in
FDA inspections or ISO audits Familiarity with
eQMS platforms
(e.g., Greenlight Guru, MasterControl, Veeva) Excellent project management and communication skills Passion for innovation, compliance, and patient impact Desire to work in a dynamic, fast-paced environment. Maintain a strong commitment to ethics, professionalism, and integrity in all interactions. Commitment to Fasikl’s mission of improving lives through cutting-edge neuro-AI technology and exceptional patient care. Why Join Fasikl
Be part of a mission-driven team pioneering a new era of
AI therapeutics Contribute to the launch and scale-up of a
first-in-class FDA-cleared product Work in a fast-paced, supportive startup environment with real patient impact Competitive compensation, equity, and benefits Job details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Medical Equipment Manufacturing Referrals increase your chances of interviewing at Fasikl by 2x We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr