WearLinq
Quality Manager - Medical Device Startup (Class II)
WearLinq, San Jose, California, United States, 95199
Position Summary
WearLinq is hiring! We are a growing medical device startup commercializing an FDA Class II device. We’re seeking a proactive, hands‑on
Quality Manager
to build, lead, and continuously improve our Quality Management System (QMS). This role is ideal for a quality professional who thrives in a fast‑paced, early‑stage environment and wants to directly influence product development, regulatory readiness, and company culture.
You will be responsible for maintaining compliance with
FDA 21 CFR Part 820
and
ISO 14971 , while also supporting design control, supplier qualification, risk management, and post‑market processes.
Key Responsibilities
Quality System Development & Compliance
Maintain and improve a right‑sized QMS tailored to a startup environment while ensuring compliance with FDA requirements.
Manage document control, change control, training records, equipment calibration, and supplier quality.
Prepare for and lead FDA and ISO audits once the company moves toward commercialization.
Design & Development Support
Partner closely with R&D to embed quality into design control activities—design reviews, verification and validation planning, risk management, and design history file maintenance.
Ensure design documentation aligns with regulatory expectations for Class II devices.
Manufacturing & Supplier Quality
Develop supplier qualification and monitoring processes appropriate for startup scale.
Support process validation and production readiness activities with manufacturing partners.
Ensure inspection and release processes are defined and traceable.
CAPA, Nonconformance, and Risk Management
Lead root cause analysis, corrective/preventive actions, and trending.
Maintain the risk management file per ISO 14971 throughout the product lifecycle.
Post‑Market Readiness
Contribute to complaint handling, vigilance, and post‑market surveillance systems as commercial activities begin.
Help establish systems for field actions and product improvements.
Leadership & Culture
Serve as the company’s primary quality lead and FDA liaison.
Provide training and guidance to cross‑functional teams on quality principles.
Promote a culture of compliance, ownership, and continuous improvement.
Qualifications Education & Experience
Bachelor’s degree in engineering, life sciences, or related technical field (advanced degree preferred).
5+ years of experience in medical device quality assurance; startup or small‑company experience strongly preferred.
Proven knowledge of
FDA 21 CFR Part 820
and
ISO 14971 .
Hands‑on experience with
design control ,
risk management , and
process validation
for Class II devices.
Experience leading or supporting
FDA inspections
or
ISO audits .
Familiarity with electronic QMS tools or willingness to implement one.
Skills & Attributes
Entrepreneurial mindset with ability to build processes from the ground up.
Excellent communication, organization, and problem‑solving skills.
Comfortable balancing regulatory rigor with startup agility.
Strong cross‑functional collaboration with R&D, operations, and regulatory teams.
Preferred Certifications
Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) a plus.
ISO 13485 Lead Auditor certification a plus.
Compensation & Benefits
Competitive startup compensation (salary + potential equity).
Health, dental, and vision insurance.
Remote work option.
Professional growth opportunities as the company scales.
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Quality Manager
to build, lead, and continuously improve our Quality Management System (QMS). This role is ideal for a quality professional who thrives in a fast‑paced, early‑stage environment and wants to directly influence product development, regulatory readiness, and company culture.
You will be responsible for maintaining compliance with
FDA 21 CFR Part 820
and
ISO 14971 , while also supporting design control, supplier qualification, risk management, and post‑market processes.
Key Responsibilities
Quality System Development & Compliance
Maintain and improve a right‑sized QMS tailored to a startup environment while ensuring compliance with FDA requirements.
Manage document control, change control, training records, equipment calibration, and supplier quality.
Prepare for and lead FDA and ISO audits once the company moves toward commercialization.
Design & Development Support
Partner closely with R&D to embed quality into design control activities—design reviews, verification and validation planning, risk management, and design history file maintenance.
Ensure design documentation aligns with regulatory expectations for Class II devices.
Manufacturing & Supplier Quality
Develop supplier qualification and monitoring processes appropriate for startup scale.
Support process validation and production readiness activities with manufacturing partners.
Ensure inspection and release processes are defined and traceable.
CAPA, Nonconformance, and Risk Management
Lead root cause analysis, corrective/preventive actions, and trending.
Maintain the risk management file per ISO 14971 throughout the product lifecycle.
Post‑Market Readiness
Contribute to complaint handling, vigilance, and post‑market surveillance systems as commercial activities begin.
Help establish systems for field actions and product improvements.
Leadership & Culture
Serve as the company’s primary quality lead and FDA liaison.
Provide training and guidance to cross‑functional teams on quality principles.
Promote a culture of compliance, ownership, and continuous improvement.
Qualifications Education & Experience
Bachelor’s degree in engineering, life sciences, or related technical field (advanced degree preferred).
5+ years of experience in medical device quality assurance; startup or small‑company experience strongly preferred.
Proven knowledge of
FDA 21 CFR Part 820
and
ISO 14971 .
Hands‑on experience with
design control ,
risk management , and
process validation
for Class II devices.
Experience leading or supporting
FDA inspections
or
ISO audits .
Familiarity with electronic QMS tools or willingness to implement one.
Skills & Attributes
Entrepreneurial mindset with ability to build processes from the ground up.
Excellent communication, organization, and problem‑solving skills.
Comfortable balancing regulatory rigor with startup agility.
Strong cross‑functional collaboration with R&D, operations, and regulatory teams.
Preferred Certifications
Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) a plus.
ISO 13485 Lead Auditor certification a plus.
Compensation & Benefits
Competitive startup compensation (salary + potential equity).
Health, dental, and vision insurance.
Remote work option.
Professional growth opportunities as the company scales.
#J-18808-Ljbffr