Udi Jobs in Ohio (NOW HIRING)

Anchor Point Technology Resources, established in 2004. Our corporate office is located in the heart of Indianapolis, Indiana, with locations in Cincinnati, OH and Louisville, KY.  Anchor Point is a locally owned WBE.
At Anchor Point, we will work closely with you to gain a precise understanding of your business so we can deliver the best solutions. Our staff of IT professionals is available to conduct technical screenings to ensure that only the most technologically proficient candidates are presented to you. We recognize that even the most technically skilled individual may not have what it takes to fit in your organization. Therefore, we also take great care in screening individuals on their non-technical abilities. Through progressive thinking, creativity and technical expertise we are able to match the perfect resource to your need.

JOB SUMMARY:  

The Supplier Quality Engineer will provide Supplier Quality support and oversight to client locations as part of the (UDI) program. This individual will be responsible for leading the global UDI implementation with suppliers to ensure that the processes implemented at the supplier's manufacturing locations are compliance to the FDA UDI requirements. The Supplier Quality Engineer must have knowledge of the UDI regulation and will be responsible for setting the strategy on how it will be implemented at the all manufacturing locations. The Supplier Quality Engineer must have some knowledge of manufacturing process, applications, and process development. The ability to effectively collaborate, influence, and coordinate amongst suppliers and team members within sourcing, materials management, design engineering, receiving inspection, and quality management at various sites is critical to this role. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: - Other duties may be assigned:

Understand Quality System requirements and adhere to procedures and instructions.

Work with UDI Core Team to develop corporate UDI process.

Interface with supplier's engineering and quality organizations to efficiently develop new processes to implement the requirements of the UDI regulation

Perform evaluations of supplier's quality systems and manufacturing processes to assess supplier's capabilities to implement UDI requirements. Develop and implement supplier risk mitigation plans when appropriate.  

Train suppliers to develop supplier's knowledge of UDI requirements.

Work with suppliers to address reported problems impacting functionality, quality, and regulatory requirements. Drive corrective and preventive actions at the supplier to preclude recurrence of identified issues.

Measure and communicate to management, global supplier progress in implementing UDI requirement. 

Escalate issues to management as appropriate.

Must be willing and flexible for business travel as required (supplier visits). Travel required may be upwards of 30%.

EDUCATION, EXPERIENCE AND QUALIFICATIONS:

Bachelor of Science in Engineering or related technical field required (Mechanical, Electrical, or Biomedical preferred).

2+ years of manufacturing, quality assurance, and/or engineering experience required.

Working knowledge of US medical device regulations (21 CFR Parts 820, 803, and 806) required.

Working knowledge of standard quality system requirements (ISO 9001, ISO 13485, Medical Device Directive, Canadian Medical Device Regulation) preferred.

Practical knowledge of FDA UDI regulation preferred.

Supplier quality experience in medical device or related GMP environment preferred.

Computer competency in Word, Excel, Powerpoint, Outlook required.  

Ability to operate independently, communicate effectively, and successfully manage multiple responsibilities required.

Leadership skills with a passion to embrace positive change for on-going operations and new initiatives required.

Fluency in English language required.

All your information will be kept confidential according to EEO guidelines.  Please send resumes to [email protected] for review