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Presidio Medical, Inc. · 2 months ago

Senior/Staff Quality Engineer (Design Assurance) - Medical Device

San Mateo, CA

Full-time

Onsite

Senior Level

$125K/yr - $165K/yr

5+ years exp

Presidio Medical, Inc. is seeking an experienced Software Quality Engineer to maintain and enhance their Quality Management System. The role involves ensuring product quality and regulatory compliance by managing key processes from design through manufacturing.

Developer PlatformInformation TechnologyMedicalSoftware

No H1B

Responsibilities

Design & Development Support: Partner with R&D to establish quality requirements and support design verification & validation (V&V), including testing for sterilization, packaging, and shelf-life

Risk Management: Maintain the Risk Management File in accordance with ISO 14971. Staff-level candidates will be expected to lead this process for assigned projects

Product & Process Control: Oversee quality activities for production, including incoming inspection, in-process testing, and final product release. Manage non-conforming product and lead investigations

Supplier Management: Qualify new suppliers, maintain the Approved Supplier List (ASL), and manage the Supplier Corrective Action Request (SCAR) program

Corrective Action: Lead the CAPA process from initiation through investigation, implementation, and verification of effectiveness

QMS & Audits: Support internal and external audits. Staff-level candidates will act as a Subject Matter Expert (SME) during audits and help lead continuous improvement initiatives for the QMS

Mentorship: Staff-level candidates will provide guidance and mentorship to junior quality engineers

Comply with Presidio Medical’s quality system requirements as well as any applicable regulatory requirements

Comply with all health and safety regulations, policies, and work practices

Other duties as assigned

Qualification

Quality engineering experienceFDA 21 CFR 820ISO 13485ISO 14971Risk Management FilesDesign controlsSoftware V&VISO 13485 Lead AuditorSubject Matter ExpertMentorship

Required

Bachelor's degree in Engineering or a related scientific field

5+ years of quality engineering experience in the medical device industry for Senior level

8+ years of progressive quality engineering experience for Staff level

Proven hands-on experience with design controls and a strong working knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971

Preferred

ISO 13485 Lead Auditor certification is a plus

Demonstrated expertise in developing and maintaining Risk Management Files

Experience with software V&V (SaMD experience is a plus)

Proven experience as a subject matter expert during external regulatory audits

Company

Presidio Medical, Inc.

We are a clinical-stage, privately held medical technology company developing a transformational neuromodulation platform to treat diseases of undesired neural activity.

Founded in 2017

South San Francisco, California, USA

11-50 employees