Location
Elk Grove Village, IL | United States
Job description
Who We Are: With over 50 years of serving the medical device and industrial markets, we are an injection molding company based in Elk Grove Village, IL. We occupy over 90,000 sq. feet of production space with 50+ injection molding machines
Position Overview: The Quality Assurance (QA) Manager is responsible for ensuring product quality and regulatory compliance. This includes providing oversight of product design, production, and product delivery. The QA Manager will be responsible for maintaining and continually improving Quality Management System and quality assurance processes to ensure product safety, reliability, and compliance with applicable regulations.
Key Responsibilities:
- Develop, implement, and maintain Quality Assurance processes, procedures, and systems to ensure product safety, reliability, and compliance with applicable regulations.
- Conduct periodic audits to ensure compliance with ISO 13485
- Verify and validate product design
- Monitor and review product performance and customer feedback to identify areas of improvement.
- Lead quality improvement projects and initiatives in support of product design, production, and product delivery.
- Provide training and mentorship to quality assurance staff.
- Interface with customers, suppliers, and other stakeholders to ensure quality and compliance.
Qualifications:
Must have:
- Bachelor’s Degree in relevant field (Engineering, Quality Assurance, Management, etc.)
- 3+ Years of experience in a Quality Assurance role in a plastic injection molding and/or medical device setting
- ISO 13485
Nice to have:
- Demonstrated leadership and project management experience
- Knowledge of FDA regulations and international standards
- Excellent communication skills
Benefits - Medical
- Vision
- Dental
- 401k
Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Drew Gilmore
Applicants must be authorized to work in the U.S.
Preferred Skills
ISO 13485
ISO-13485
ISO13485
Medical Device
Medical Devices
QA
QC
Quality Assurance
plastic
Plastics
Job tags
Salary
$80k - $110k
