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Quality Control Inspector, Neurovascular Medical Device Industry

QAPEL MEDICAL INC
Fremont, CA Full Time
POSTED ON 4/9/2025
AVAILABLE BEFORE 5/9/2025

Position Title : Quality Control Inspector Job Location : 4245 Technology Drive, Fremont, CA 94538

Department : Quality Assurance Worker Category : Full-Time / Non-Exempt

Industry : Neurovascular / Medical Devices

2 Shift Options :

QC Inspector (#1) hours will be 6 : 00 am - 2 : 30 pm

QC Inspector (#2) hours will be 8 : 30 am - 5 : 00 pm

About Q’Apel :

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 which requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.

Who We Want :

Q’Apel Is looking for a Quality Control Inspector who thrives in a fast-paced startup environment. As a pivotal member of our team, you will wear multiple hats, contributing not only to quality assurance but also to the overall growth and success of our company. You are a proactive problem-solver, excellent communicator, and enthusiastic about learning and adapting to new challenges. If you are passionate about delivering high-quality products and have a keen eye for detail, we want you to join us on our exciting journey.

What You’ll Work On :

  • Performs QC inspections to work in progress (WIP) product and incoming components.
  • Perform inspection and testing activities pertaining to manufacturing in process, IQA, First Article Inspections (FAI), final packaging. Generate detailed and accurate inspection data sheets in accordance with current Good Manufacturing Practices (cGMP) and Q’Apel’s Quality Management System (QMS) requirements.
  • Generate NCMRs and assist in the investigations of nonconformances. Work with engineering and operations staff to resolve issues in a timely and effective manner.
  • Assure equipment used for inspection activities are qualitied prior to use.
  • Identify potential improvements for inspection systems and processes.
  • Assure that the company’s QMS is compliant with current FDA QSR, ISO 13485 : 2016, and other standards as applicable.
  • Support the Q’Apel’s Quality Policy and Quality System. Be aware of QS procedures and requirements, including regulatory requirements, and training requirements for the position. Inform responsible personnel of concerns involving product quality.
  • Perform job functions in a safe and effective manner. Adhere to the safety procedures of the company.
  • Other duties as assigned.

What You Bring : Education :

  • High School Diploma
  • AA degree, or equivalent experience, in a technical discipline preferred.
  • Experience & Skills :

  • 1 years minimum experience working in a regulated industry (medical device experience preferred, along with a solid working knowledge of FDA Quality System Regulations and ISO 13485).
  • Experience performing QA inspection / testing activities pertaining to IQA and in process.
  • Familiar with testing equipment such as, but not limited to, Microscope, Instron, video inspection systems, borescope, etc.
  • Ability to interpret and read technical specification and mechanical drawings.
  • Experience working in a controlled environment room (CER)
  • Good manual dexterity and visual acuity.
  • Strong interpersonal skills.
  • Effective communication skills (both written and verbal) required.
  • Experience in a small company environment is a plus.
  • Knowledge and exposure to applicable regulations (QSR, and ISO).
  • Ability to work and independently or in in a team setting.
  • Works well under pressure, organized, and self-motivated.
  • Our compensation 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 consider the current market rate, and the title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your compensation. The compensation range for this full-time, non-exempt position is between $28 / hr to $30 / hr equity benefits.

    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.

    2 Shift Options :

    QC Inspector (#1) hours will be 6 : 00 am - 2 : 30 pm

    QC Inspector (#2) hours will be 8 : 30 am - 5 : 00 pm

    2 Shift Options :

    QC Inspector (#1) hours will be 6 : 00 am - 2 : 30 pm

    QC Inspector (#2) hours will be 8 : 30 am - 5 : 00 pm

    PI261660550

    Salary : $28 - $30

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