Quality Technician

Experis; Fremont (CA); On-site; USD 40,000 - 41,000; Full time

Job summary

Q’Apel Medical, Inc. is seeking a Manufacturing Technician III / Catheter Assembly Technician to support and maintain efficient production operations. A minimum of 3–5 years of manual catheter assembly experience in neurovascular devices is required.

The role involves detailed assembly under SOPs, microscope-based tasks, CER work, and strict adherence to FDA/ISO quality standards. Candidates must be able to lift up to 10 lbs and thrive in a fast-paced environment.

Qualifications

• Minimum 3–5 years of catheter assembly experience in neurovascular or medical devices.
• Excellent manual dexterity and good visual acuity.
• Strong written and verbal communication skills.
• Ability to work independently or in a team in a regulated environment.
• Experience with FDA Quality Systems Regulations and ISO 13485 is required.
• Ability to lift up to 10 lbs or more; CER environment experience.

Responsibilities

• Daily manual assembly of neurovascular catheters per SOP.
• Perform manufacturing inspection and testing to meet specifications.
• Maintain accurate documentation and records.
• Work daily in the controlled environment room (CER).
• Follow FDA and ISO quality systems in daily tasks.
• Troubleshoot production issues and suggest improvements.
• Investigate and test new or revised procedures.
• Adhere to SOPs and manufacturing procedures.
• Operate microscope and manual cutters as required.
• Open, lift, and package shipper boxes ~10 lbs.
• Maintain consistent daily product output.
• Adapt to switching stations/tasks as needed.

Skills

Manual dexterity

Visual acuity

Effective communication

Independent/teamwork

Organizational skills

Regulated industry experience

CER experience

Lifting up to 10 lbs

Education

High School diploma

Tools

Microscope

Manual cutters

Job description

At Q’Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we’re 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. That’s where Q’Apel comes in.

Successful Q’Apel 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

Manufacturing Technician III / Catheter Assembly Technician 3

Job Location

4245 Technology Drive,Fremont, CA 94538

Worker Category

Full-Time/Non-Exempt

Schedule

Monday - Friday

Shift

6:00 AM - 2:30 PM

Who We Want

Q’Apel is seeking a Manufacturing Technician 3 / Catheter Assembler to support and maintain efficient, timely, and effective production operations. A minimum of 3-4 years of manual catheter assembly experience in the Neurovascular Devices Industry, Neurointerventional, Endovascular Neurosurgery, Neuro-interventional, Coronary or Peripheral Medical Device sectors is required to be considered. The ideal candidate will have recent hands‑on experience assembling neurovascular catheters, demonstrating excellent manual dexterity, visual acuity, strong attention to detail, and the ability to follow strict instructions. The assembly process must be followed exactly from the written Standard Operating Procedures (SOP's) to meet safety and high-quality standards. We’re looking for someone who has proven and proficient microscope skills capable of performing detailed assembly and inspection tasks for extended periods (up to 8 hours per day). Can safely and effectively operate manual cutting tools and other assembly equipment. Follows work instructions accurately and consistently to ensure high product quality and deliver on output. The ideal assembly technician must be comfortable working in a dynamic environment with rapidly changing priorities and demonstrate flexibility to quickly adjust to new tasks and assignments as needed. At Q’Apel, every team member “steps up to the plate.” We are a fast‑paced, high‑growth company with a startup mindset. We value collaboration, adaptability, and a positive attitude toward change. If you thrive in a dynamic environment and take pride in precision work, we’d love to have you on our team.

What You’ll Work On

• Daily accurate manual assembly associated with the manufacturing technician III of the neurovascular catheter per SOP guidelines.
• Supports production needs as scheduled and remains flexible.
• Performs manufacturing inspection and testing of catheter products to ensure they meet specifications.
• Accurate documentation and consistent records maintenance.
• Working daily in the controlled environment room (CER).
• Accurately and consistently follow FDA Quality Systems Regulations and various ISO
• Solve production issues and identify improvements.
• Investigate and test new or revised production procedures.
• Adheres to approved standard operating procedures and manufacturing procedures.
• Unlimited/continuous use of a microscope.
• Unlimited/continuous use of manual cutters.
• Opening, lifting, and packaging shipper boxes approximately 10 lbs. in weight on a continuous basis.
• Provide consistent daily product output.
• Ability to stay flexible and transition from one station to another, one task to another.
• Daily communication and ability to clearly explain any assembly-related problems.
• Strong problem-solving skills.
• Other duties as requested.

What You Bring

Education

High School degree required

Experience & Skills required

• Minimum 3-5 years of recent catheter assembly experience required.
• Good manual dexterity and visual acuity required.
• Effective communication skills (both written and verbal) required.
• Ability to work independently or in a team setting.
• Ability to lift up to 10 lbs or more
• Must be organized and self‑motivated
• Minimum 3-5 years of experience working in a regulated industry (medical device development experience, along with a solid working knowledge of FDA Quality System Regulations and ISO 13485 and other ISOs)
• Minimum 3-5 years of experience working in a controlled environment room (CER) required
• Knowledge and exposure to applicable regulations (QSR, MDD, CMDR, and ISO) required

Compensation

The hourly compensation range for this full‑time, non‑exempt position is between $29.00/hour to $30.00/hour.

Confidentiality Notice

This document contains confidential, proprietary information of Q’Apel Medical, Inc. It may not be copied or reproduced without prior written permission from Q’Apel Medical, Inc