Job Title: Manufacturing Quality Engineer - Medical Device
Company: Novozen Healthcare LLC.
Location: Madison, WI (100% Onsite)
Employment Type: Contract
Role Overview
We are looking for an experienced Manufacturing Quality Engineer to support manufacturing operations, product quality, process validation, and continuous improvement.
The ideal candidate will have 5+ years of manufacturing quality experience, preferably in medical device or another regulated manufacturing environment.
Key Responsibilities:
- Support manufacturing quality and process validation activities.
- Review and approve manufacturing process changes.
- Troubleshoot manufacturing and product quality issues.
- Manage product release and review manufacturing records.
- Handle nonconforming products, rework, and disposition activities.
- Perform root cause investigations and CAPA.
- Support continuous improvement and manufacturing process improvements.
- Create, review, and maintain SOPs and quality documentation.
- Support internal and external quality audits.
- Work closely with Manufacturing Engineering, Production, Quality, and other teams.
- Troubleshoot mechanical, electrical, and hardware-related product issues.
- Ensure manufacturing activities meet quality and regulatory requirements.
Required Qualifications:
- 5+ years of Manufacturing Quality Engineering experience preferred.
- Minimum 3+ years of genuine relevant experience required.
- Experience with process validation, CAPA, root cause analysis, and nonconformance investigations.
- Experience with product release and manufacturing quality processes.
- Hands-on experience with mechanical, electrical, or hardware products.
Preferred Qualifications:
- Medical device manufacturing experience.
- Experience with low-volume, high-complexity products.
- Experience with regulatory audits and quality management systems.
Pay Scale - Anticipated hourly pay range: specific range such as ($33/hr to $35/hr)(DOE)
Benefits - Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
- Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
- Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
- Paid Time Off (PTO): No PTO other than that required by applicable state and local laws