Aliph Medical
Senior Director of Quality Assurance
Aliph Medical, Lake Forest, California, United States, 92630
Company Overview
Aliph Medical, Inc. is a purpose-driven medical-device startup. We are developing a true all-in-one full-eyeocular diagnostic platform based on the state-of-the-art Swept-Source Optical Coherence Tomography paired with advancedAI analytics. The platform caters to ophthalmology, optometry, and oculomics applications. We believe all patients deserve to receive the best level of care. We have the technologies, tools, determination, and people to achieve our ambitious goal.
Position Overview We are seeking a highly experienced Senior Director of Quality Assurance & Regulatory Affairs to establish and manage our electronic Quality Management System (eQMS), ensure compliance with applicable standards and regulations, act as the primary quality engineering authority for the organization, and drive compliance and regulatory readiness across the organization.
As a leader undertaking this role, you need to have intimate knowledge of medical device regulations and electronic quality systems. You will need to be a self‑starter, comfortable with a fast‑paced workplace, able to achieve goals within a high level of ambiguity, work across functional lines, and take a hands‑on approach.
Job Responsibilities
Develop, implement, and maintain a compliant and scalable eQMS based on GreenLight Guru
Establish documentation required for applicable standards
Lead Design Controls and establish DHF ownership
Establish Risk Management framework
Own and execute CAPA system, Nonconformance Management, Compliance Handling, and Internal Audits
Prepare the organization for FDA and Notified Body Audits
Update and execute regulatory strategy for Class II devices
Lead FDA submissions, including 510(k) and Q‑Sub / Pre‑Submission interactions
Work with the company’s Chief Medical Officer, CA, and RA consultants to establish a solid regulatory submission plan
Act as primary point of contact with FDA
Ensure compliance with 21 CFR Part 820 as a primary goal
Support future compliance with EU MDR and applicable regulations in China
Work with R&D to enter Design Controls and establish Design Inputs and Design Outputs
Train teams on QA and RA procedures and expectations
Establish V&V Plans, Procedures, and Reports
Ensure V&V testing is done in compliance with applicable standards
Support Supplier qualification and oversight
Provide QA and RA input to leadership and investors
Eventually hire and mentor quality & regulatory staff as the company scales
Serve as a calm, credible leader during audits and inspections
Qualifications and Requirements
Bachelor’s degree in Engineering, Life Sciences, or related field
10+ years in Quality and regulator roles in medical devices
3+ years of them in early‑to‑mid‑stage start‑ups
Direct experience with GreenLight Guru or similar eQMS
Proven experience building or significantly upgrading an eQMS
Direct experience with Class II devices. Experience with Class I & III is desired
Direct experience with hardware‑ and software‑based medical devices
Experience with AI‑submissions is desired
Hands‑on ownership of FDA 510(k) and EU MDR submissions
Experience with 21 CFR Part 820, ISO 13485 & ISO 14971
Experience taking a product from concept to clearance to early market
Self‑starter. Comfortable with ambiguity and limited resources
Hands‑on and detail‑oriented, while strategically minded
Strong communicator with FDA, auditors, and internal teams
High integrity and accountability
What Success Looks Like (12–18 Months)
QMS implemented, adopted, and audit‑ready
V&V completed
Successful FDA and EU MDR interactions
Clean internal audits and inspection readiness
Quality integrated into product development culture
Foundation in place for submissions and clearances
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Position Overview We are seeking a highly experienced Senior Director of Quality Assurance & Regulatory Affairs to establish and manage our electronic Quality Management System (eQMS), ensure compliance with applicable standards and regulations, act as the primary quality engineering authority for the organization, and drive compliance and regulatory readiness across the organization.
As a leader undertaking this role, you need to have intimate knowledge of medical device regulations and electronic quality systems. You will need to be a self‑starter, comfortable with a fast‑paced workplace, able to achieve goals within a high level of ambiguity, work across functional lines, and take a hands‑on approach.
Job Responsibilities
Develop, implement, and maintain a compliant and scalable eQMS based on GreenLight Guru
Establish documentation required for applicable standards
Lead Design Controls and establish DHF ownership
Establish Risk Management framework
Own and execute CAPA system, Nonconformance Management, Compliance Handling, and Internal Audits
Prepare the organization for FDA and Notified Body Audits
Update and execute regulatory strategy for Class II devices
Lead FDA submissions, including 510(k) and Q‑Sub / Pre‑Submission interactions
Work with the company’s Chief Medical Officer, CA, and RA consultants to establish a solid regulatory submission plan
Act as primary point of contact with FDA
Ensure compliance with 21 CFR Part 820 as a primary goal
Support future compliance with EU MDR and applicable regulations in China
Work with R&D to enter Design Controls and establish Design Inputs and Design Outputs
Train teams on QA and RA procedures and expectations
Establish V&V Plans, Procedures, and Reports
Ensure V&V testing is done in compliance with applicable standards
Support Supplier qualification and oversight
Provide QA and RA input to leadership and investors
Eventually hire and mentor quality & regulatory staff as the company scales
Serve as a calm, credible leader during audits and inspections
Qualifications and Requirements
Bachelor’s degree in Engineering, Life Sciences, or related field
10+ years in Quality and regulator roles in medical devices
3+ years of them in early‑to‑mid‑stage start‑ups
Direct experience with GreenLight Guru or similar eQMS
Proven experience building or significantly upgrading an eQMS
Direct experience with Class II devices. Experience with Class I & III is desired
Direct experience with hardware‑ and software‑based medical devices
Experience with AI‑submissions is desired
Hands‑on ownership of FDA 510(k) and EU MDR submissions
Experience with 21 CFR Part 820, ISO 13485 & ISO 14971
Experience taking a product from concept to clearance to early market
Self‑starter. Comfortable with ambiguity and limited resources
Hands‑on and detail‑oriented, while strategically minded
Strong communicator with FDA, auditors, and internal teams
High integrity and accountability
What Success Looks Like (12–18 Months)
QMS implemented, adopted, and audit‑ready
V&V completed
Successful FDA and EU MDR interactions
Clean internal audits and inspection readiness
Quality integrated into product development culture
Foundation in place for submissions and clearances
#J-18808-Ljbffr