Aliph Medical · 1 day ago
Senior Director of Quality Assurance
Lake Forest, CA
Full-time
Onsite
Director/Executive
10+ years expAliph Medical, Inc. is a purpose-driven medical-device startup developing a cutting-edge ocular diagnostic platform. They are seeking a highly experienced Senior Director of Quality Assurance & Regulatory Affairs to establish and manage their electronic Quality Management System, ensure compliance with regulations, and lead quality engineering efforts across the organization.
Medical Device
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
Qualification
Required
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
Direct experience with hardware- and software-based medical devices
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
Preferred
Experience with Class I & III is desired
Experience with AI-submissions is desired
Company
Aliph Medical
Aliph Medical is a purpose-driven medical-device startup. We believe all patients deserve to receive the best level of care.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase