About QApel:
At QApel, we are passionate about revolutionizing neurovascular access. In the simplest sense, were a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. Thats where QApel comes in.
Successful QApel team members step up to the plate and work together to achieve our goals every single day. We are a fast-paced, high-growth company with a startup philosophy that requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.
Position Title: Post-Market Surveillance Analyst
Job Location: 4245 Technology Drive, Fremont, CA 94538 (Onsite)
Worker Category: Full-Time/Exempt
Who We Want:
As a Post-Market Surveillance Analyst, you will support QApels complaint handling and post-market surveillance program from two directions at once: the administrative processing of complaints and MDR-reportable events, and the hands-on engineering analysis of returned devices. You will help the team keep pace with a growing volume of complaint and MDR case activity driven by increased Zebra complaint volume and the upcoming Lynx launch while supporting tracking and trending, Emerging Trends meetings, and clinical documentation data needs.
What Youll Work On:
As a Post-Market Surveillance Analyst, you will support QApels complaint handling and post-market surveillance program from two directions at once: the administrative processing of complaints and MDR-reportable events, and the hands-on engineering analysis of returned devices. You will help the team keep pace with a growing volume of complaint and MDR case activity driven by increased Zebra complaint volume and the upcoming Lynx launch while supporting tracking and trending, Emerging Trends meetings, and clinical documentation data needs.
Complaint & MDR Case Administration:
- Process incoming complaints, including intake, documentation, and case file management in the eQMS.
- Prepare and manage MDR-reportable event case documentation and timelines, ensuring on-time regulatory filing.
- Support complaint aging management and help maintain on-time closure targets across the growing case volume.
- Coordinate with Regulatory, Clinical, and R&D on case-specific follow-up needs.
Returned Device Engineering Analysis:
- Receive, inspect, and perform failure analysis on returned devices (e.g., fracture, separation, kink, and other integrity-related complaints).
- Distinguish between device-related, use-related, and shipping/handling-related root causes using physical evidence (visual inspection, dimensional checks, photos/video) and case history.
- Draft clear, well-supported technical write-ups of findings to support MDR narratives and CAPA investigations.
- Coordinate with R&D and Manufacturing on design- or process-related trend findings identified through returned device analysis.
Trending, Reporting & Continuous Improvement:
- Compile and maintain complaint and MDR tracking & trending data; prepare materials for and participate in Emerging Trends meetings.
- Support data requests for clinical documentation deliverables (CERs, PSURs, PMCF reports).
- Support continuous improvement of the post-market surveillance process, including aging/dashboard tooling and eQMS-related process updates.
- Support company goals and objectives, policies and procedures; ensure compliance with Quality System Regulations and ISO 13485:2016 requirements.
- Perform other duties as assigned.
Working Conditions & Biohazard Safety
This role involves direct physical handling of devices returned from clinical use, which may carry biohazard exposure risk.
- Returned devices submitted for inspection or failure analysis may have been in contact with patient blood, tissue, or other bodily fluids and must be treated as a biohazard until formally assessed and, if applicable, decontaminated per QApels internal procedures.
- Employees in this role must complete and maintain current Bloodborne Pathogens (BBP) training and follow all applicable biohazard handling and decontamination procedures before receiving, inspecting, or performing failure analysis on returned devices.
- Appropriate personal protective equipment (PPE) including gloves, eye protection, and any additional safeguards specified by the applicable SOP must be worn when receiving, inspecting, or handling returned devices.
- Returned devices and any associated biohazard waste must be stored, transported, and disposed of in accordance with regulated medical waste procedures.
- Any suspected exposure incident (e.g., needlestick, sharps injury, contact with bodily fluids) must be reported immediately to management.
- Role requires extended periods at a lab bench/inspection station and the ability to safely handle small mechanical components using lab and inspection equipment (e.g., microscopy, dimensional inspection tools).
What You Bring:
Education:
- Bachelors degree in an engineering, life science, or related technical discipline required. Applicable work experience may be substituted for education experience.
Experience & Skills:
- Minimum 36 years of experience in complaint handling, post-market surveillance, or quality engineering within the medical device industry.
- Working knowledge of MDR reporting requirements and complaint handling regulations (21 CFR 803/820, ISO 13485:2016).
- Demonstrated experience performing failure analysis or root-cause investigation on returned/failed hardware; catheter or other minimally invasive device experience strongly preferred.
- Strong technical writing skills, with the ability to produce clear, well-supported findings for regulatory and CAPA documentation.
- Comfortable managing a steady caseload across both administrative and hands-on technical work without either falling behind.
- Experience with tracking & trending, data compilation, or supporting clinical documentation data requests a plus.
- Detail-oriented, organized, and able to manage multiple cases and deadlines simultaneously.
The anticipated salary range for candidates who will work in Fremont, California is $130,000 to $145,000. Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as considering the current market rate, and title may be assessed one level lower or higher accordingly.
This document contains confidential, proprietary information of QApel Medical, Inc. It may not be copied or reproduced without prior written permission from QApel Medical, Inc
PIae149dcefe06-26289-41395854
About QApel:
At QApel, we are passionate about revolutionizing neurovascular access. In the simplest sense, were a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. Thats where QApel comes in.
Successful QApel team members step up to the plate and work together to achieve our goals every single day. We are a fast-paced, high-growth company with a startup philosophy that requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.
Position Title: Post-Market Surveillance Analyst
Job Location: 4245 Technology Drive, Fremont, CA 94538 (Onsite)
Worker Category: Full-Time/Exempt
Who We Want:
As a Post-Market Surveillance Analyst, you will support QApels complaint handling and post-market surveillance program from two directions at once: the administrative processing of complaints and MDR-reportable events, and the hands-on engineering analysis of returned devices. You will help the team keep pace with a growing volume of complaint and MDR case activity driven by increased Zebra complaint volume and the upcoming Lynx launch while supporting tracking and trending, Emerging Trends meetings, and clinical documentation data needs.
What Youll Work On:
As a Post-Market Surveillance Analyst, you will support QApels complaint handling and post-market surveillance program from two directions at once: the administrative processing of complaints and MDR-reportable events, and the hands-on engineering analysis of returned devices. You will help the team keep pace with a growing volume of complaint and MDR case activity driven by increased Zebra complaint volume and the upcoming Lynx launch while supporting tracking and trending, Emerging Trends meetings, and clinical documentation data needs.
Complaint & MDR Case Administration:
- Process incoming complaints, including intake, documentation, and case file management in the eQMS.
- Prepare and manage MDR-reportable event case documentation and timelines, ensuring on-time regulatory filing.
- Support complaint aging management and help maintain on-time closure targets across the growing case volume.
- Coordinate with Regulatory, Clinical, and R&D on case-specific follow-up needs.
Returned Device Engineering Analysis:
- Receive, inspect, and perform failure analysis on returned devices (e.g., fracture, separation, kink, and other integrity-related complaints).
- Distinguish between device-related, use-related, and shipping/handling-related root causes using physical evidence (visual inspection, dimensional checks, photos/video) and case history.
- Draft clear, well-supported technical write-ups of findings to support MDR narratives and CAPA investigations.
- Coordinate with R&D and Manufacturing on design- or process-related trend findings identified through returned device analysis.
Trending, Reporting & Continuous Improvement:
- Compile and maintain complaint and MDR tracking & trending data; prepare materials for and participate in Emerging Trends meetings.
- Support data requests for clinical documentation deliverables (CERs, PSURs, PMCF reports).
- Support continuous improvement of the post-market surveillance process, including aging/dashboard tooling and eQMS-related process updates.
- Support company goals and objectives, policies and procedures; ensure compliance with Quality System Regulations and ISO 13485:2016 requirements.
- Perform other duties as assigned.
Working Conditions & Biohazard Safety
This role involves direct physical handling of devices returned from clinical use, which may carry biohazard exposure risk.
- Returned devices submitted for inspection or failure analysis may have been in contact with patient blood, tissue, or other bodily fluids and must be treated as a biohazard until formally assessed and, if applicable, decontaminated per QApels internal procedures.
- Employees in this role must complete and maintain current Bloodborne Pathogens (BBP) training and follow all applicable biohazard handling and decontamination procedures before receiving, inspecting, or performing failure analysis on returned devices.
- Appropriate personal protective equipment (PPE) including gloves, eye protection, and any additional safeguards specified by the applicable SOP must be worn when receiving, inspecting, or handling returned devices.
- Returned devices and any associated biohazard waste must be stored, transported, and disposed of in accordance with regulated medical waste procedures.
- Any suspected exposure incident (e.g., needlestick, sharps injury, contact with bodily fluids) must be reported immediately to management.
- Role requires extended periods at a lab bench/inspection station and the ability to safely handle small mechanical components using lab and inspection equipment (e.g., microscopy, dimensional inspection tools).
What You Bring:
Education:
- Bachelors degree in an engineering, life science, or related technical discipline required. Applicable work experience may be substituted for education experience.
Experience & Skills:
- Minimum 36 years of experience in complaint handling, post-market surveillance, or quality engineering within the medical device industry.
- Working knowledge of MDR reporting requirements and complaint handling regulations (21 CFR 803/820, ISO 13485:2016).
- Demonstrated experience performing failure analysis or root-cause investigation on returned/failed hardware; catheter or other minimally invasive device experience strongly preferred.
- Strong technical writing skills, with the ability to produce clear, well-supported findings for regulatory and CAPA documentation.
- Comfortable managing a steady caseload across both administrative and hands-on technical work without either falling behind.
- Experience with tracking & trending, data compilation, or supporting clinical documentation data requests a plus.
- Detail-oriented, organized, and able to manage multiple cases and deadlines simultaneously.
The anticipated salary range for candidates who will work in Fremont, California is $130,000 to $145,000. Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as considering the current market rate, and title may be assessed one level lower or higher accordingly.
This document contains confidential, proprietary information of QApel Medical, Inc. It may not be copied or reproduced without prior written permission from QApel Medical, Inc
PIae149dcefe06-26289-41395854
