Quality Engineer

Job Title: Quality Engineer

Location: Franklin Lakes, NJ

Contract Term: 5+ Months

Weekly 40.00 Hours [Mon - Fri]

Description:

This position is responsible for the support of regulatory submissions required to market medical devices in the U.S., Europe and other international markets and sustaining-engineering related regulatory affairs activities for BD Diabetes Care. Requires the analysis of data, problem solving and evaluations of various factors.

Responsibilities:

1. Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.

2. Support preparations for technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.

3. Support notifications to the Notified Body about significant changes to CE marked products in a timely manner.

4. Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.

5. Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.

6. Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary

7. Support International Registrations as it relates to product changes and/or new product launches

8. Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.

9. Create and maintain regualtory performance metrics.

10. Identify opportunities to improve the existing process and implement the improvements.

11. Work with Regulatory Project Manager to execute large scale projects, e.g. EU MDR

Carry out the above tasks with limited supervision.

Education:

B.S. degree or higher in a life science or technical discipline, preferably in biology, or chemistry, engineering, bioengineering and regulatory affairs.

Licenses/Certifications:

RAPS Certification is a plus

Experience:

1. 5-7 years regulatory affairs experience in medical device regulations

2. Understanding of US, EU and international medical device regulatory requirements

Special Skills:

1. Proficient in using various computer programs.

2. Strong oral and written communication skills

3. Project management skills.

4. Handle multiple tasks and prioritization skills.

5. Attention to details.