Quality Manager - Medical Device Startup (Class II)
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.
Apply tot his job
Apply To this Job
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.
Apply tot his job
Apply To this Job