Overview In this role you drive quality across products from development to production, ensuring compliance with regulatory standards. You'll partner with engineering, manufacturing, and suppliers to implement QMS elements, design testing methods, and investigate defects. You'll operate in a regulated environment and contribute to continuous improvement of quality objectives. This position offers the chance to impact the treatment of serious diseases within a collaborative, learning-focused team.
Compensation / Benefits- medical, dental, vision
- life and AD&D insurance
- 401(k) with employer match
- paid parental leave
- eleven paid company holidays
- paid vacation and sick time
Responsibilities- Collaborate on development and qualification activities for new and existing products
- Collaborate on testing/inspection methodology and documentation
- Participate in Quality Objective teams
- Design and install QC sampling systems and statistical techniques
- Design or specify inspection/testing mechanisms and equipment
- Perform failure analyses and defect investigations
- Analyze production limitations and standards
- Recommend revisions of specifications
- Interface with engineering, customers, and suppliers on quality issues
- Develop standard operating procedures and facilitate internal audits
- Adhere to QMS and applicable quality regulations and standards
- Ensure remaining within regulatory, security, and compliance requirements
- Promote company-wide adherence to quality systems and procedures
- Perform other related duties as assigned
Key requirements- 2+ years in quality engineering or relevant experience
- Familiarity with QSR, ISO and other applicable regulations
- Engineering experience in a manufacturing environment; medical device industry preferred
- Experience with electronic devices and/or PCBAs
- Strong verbal, written, and interpersonal communication
- Proficiency with MS Word, Excel, and PowerPoint
- strong communication
- interpersonal skills
- team collaboration
- Quality Engineering
- Quality Management System (QMS)
- statistical sampling and techniques
