What are the responsibilities and job description for the Design Quality Engineer position at Novozen Healthcare LLC?
Design Quality Engineer
Location: Warsaw, IN
Employment Type: Contract – W2
About the Role
We are seeking an experienced Design Quality Engineer to support New Product Development (NPD) projects in the medical device industry. This role will focus on design control deliverables, documentation review, regulatory compliance, and risk mitigation while collaborating with R&D, Regulatory, Supply Chain, and Project Management teams.
Key Responsibilities
- Support NPD projects and ensure timely completion of design control deliverables.
- Review design documentation and provide quality and compliance guidance.
- Support design inputs, outputs, design reviews, verification, validation, and design transfer activities.
- Collaborate with R&D, Regulatory, Supply Chain, Project Management, and suppliers.
- Lead documentation review discussions and provide feedback to cross-functional teams.
- Identify compliance gaps and support risk mitigation activities.
- Contribute to quality improvement initiatives; CAPA experience is a plus.
Required Qualifications
- 4 years of Design Quality Engineering experience.
- Medical device industry experience.
- Strong knowledge of design controls and the product development lifecycle.
- Experience with design inputs, outputs, verification, validation, and design transfer.
- Experience working with suppliers and cross-functional stakeholders.
- Excellent communication, documentation review, and collaboration skills.
Preferred Qualifications
- Experience with CAPA processes and quality investigations.
- Experience supporting NPD projects in a regulated medical device environment.
Salary
The hourly rate for this position is $40-45/hr on W2, depending on experience and qualifications.
Benefits
Eligible employees may have access to benefits offered by Novozen Healthcare LLC in accordance with the applicable benefit plans and eligibility requirements.
Equal Employment Opportunity
Novozen Healthcare LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
Background Check
Background checks may be conducted in accordance with applicable law.
Work Authorization
Applicants must be authorized to work in the United States.
Salary : $40 - $45