Highlights
Support Vault DMR updates and maintain accuracy of controlled manufacturing records and related documentation. Support InfoPV equipment qualification activities, including documentation, execution support, and traceability.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Management Consulting Services |
| Salary | $35.18–$38.79 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
Description
Our Client, a Medical Devices / Healthcare company, is looking for a Manufacturing Engineer for their Warsaw, IN location.
Responsibilities:
- Support site Quality records such as NCR's, IE's, and CAPA's.
- Own and Review ECRs, ECNs, routers, BOM updates, and work instructions.
- Walk processes to assess readiness, risks, and implementation needs.
- Support equipment installation, qualification, validation, and decommissioning activities.
- Assist with protocol creation, execution support, and report activities tied to manufacturing changes.
- Support MES readiness and manufacturing master data activities.
- Use Windchill to review, manage, and support engineering documentation and change activity.
- Support InfoPV equipment qualification activities, including documentation, execution support, and traceability.
- Apply Gage R&R methods to evaluate measurement system capability and support process controls.
- Develop, review, and maintain control plans to ensure manufacturing process consistency and compliance.
- Support Vault DMR updates and maintain accuracy of controlled manufacturing records and related documentation.
- Partner with Operations and Quality to improve flow, efficiency, and manufacturability.
Requirements:
- Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related engineering field.
- Experience in manufacturing engineering in a regulated production setting.
- Strong Windchill knowledge.
- Working knowledge of equipment qualification/validation processes and documentation.
- Experience with Gage R&R studies and interpretation.
- Strong control plan knowledge.
- Experience with Vault DMR updates and controlled document maintenance.
- Experience with process changes, documentation, and cross-functional implementation.
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.