Full-Time
Location: Alameda California
Join a global leader in innovative medical technologies. If you’re passionate about improving patient outcomes and ensuring uncompromising product quality, this role offers the opportunity to make a real impact.
What you'll do?
Responsible for developing, implementing, and maintaining quality system elements to support both new and existing medical device products. You will work on moderately complex problems, analyze key data and trends, and collaborate across multiple engineering and operations teams to drive quality excellence.
This role is on‑site and part of a mission‑driven organization transforming patient care.
Minimum Requirements
- Associate’s or Bachelor’s in Engineering, Life Sciences, or related field.
- 3 years of experience in quality engineering or similar roles, ideally in medical devices or other regulated industries.
- Familiarity with QSR, ISO, and related regulations.
- Manufacturing engineering background.
- Experience working with electronic devices and PCBAs.
- Strong communication skills—verbal, written, and interpersonal.
- Proficiency with MS Word, Excel, PowerPoint.
Product & Process Quality
- Support qualification and development activities for new and existing products.*
- Develop testing and inspection methodologies and documentation.*
- Design QC sampling systems, statistical techniques, and inspection mechanisms.*
- Perform failure analysis and defect investigations.*
- Work closely with engineering teams, suppliers, and customers on quality‑related matters.*
- Recommend specification revisions and analyze production limitations.*
- Participate in Quality Objective teams.*
- Develop SOPs and facilitate internal audits.*
- Ensure compliance with Quality Management System (QMS) and global regulatory requirements.*
- Promote adherence to security, privacy, and compliance standards.*
- Ensure departmental compliance with QMS, regulations, and standards.*
- Support additional work-related tasks as assigned.
- Possible exposure to blood‑borne pathogens.
- Ability to lift up to 25 lbs and move between buildings/floors.
Extended periods working on a computer.
Daily interaction with team members across all levels.