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Product Surveillance Engineer Job - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Warsaw, IN Warsaw, Indiana |
About this job
Product Surveillance Engineer needed for a contract position with Yoh's client located in Warsaw, IN
The Big Picture - Top Skills You Should Possess:
- BS in Engineering with Medical device or an FDA-regulated environment experience
What You'll Be Doing:
- Responsible for the investigation and resolution of product complaints of all scopes for the U.S. Reconstructive division. Required to communicate in an effective manner with internal employees, the sales force, and medical professionals.
- Performs data analysis and reconciles recall data.
- Drafts monthly status reports for recalls for review.
- Conducts effectiveness checks in the US and internationally.
- Evaluates recall elements needed to complete recall activities.
- Create or verify consignee lists and affected product lists.
- Collaborates with Field Action Coordinators, other departments and cross-functional teams to obtain necessary data and documents to support recall reporting.
- Assesses CAPAs to ensure completeness.
- Serves as point person for distributors to verify and clarify recall compliance.
- Works independently with little Supervision required; addresses issues without prompting by the Supervisor much of the time.
What You Need to Bring to the Table:
- BA in an engineering discipline or bachelor's degree in another field with ASQ CQE certification.
- Minimum of three (3-5) years experience in a process engineering, development engineering, quality engineering or regulatory compliance role within the medical device or an FDA-regulated environment
- Individual should be proficient with use of Excel data analysis tools, database creation and management. Working knowledge of JDE, DCS, and Impromptu is helpful.
- Should have experience in writing reports and developing metrics.
- Excellent oral and written skills required.
- Regulatory requirements governing Corrections and Removals.
If This Sounds Like You, Apply Now!
Recruiter: James Dangler
Phone Number: 585-327-7475
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V
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Ref: 1055425
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