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Compliance Engineer-Specialist

PointOne Recruiting Solutions • New Berlin, WI

Posted 1 month ago

Job Snapshot

Full-Time
Experience - 2 to 7 years
Degree - 4 Year Degree
$55,000 - $65,000/Year
Medical Equipment, Manufacturing
Engineering, Government, QA - Quality Control

Job Description

Compliance Engineer/Specialist

 

                Ready for a new challenge, and motivated to make an impact working for a leading global company? If you want to grow your career and fill an important position, then you could be what our client is looking for in their Compliance Engineer. This role will manage critical. Compliance-related tasks and documentation by acting as key contributor to risk management process, which includes interpreting regulations and international standards and communicating how they relate to company products and processes. Will also investigate complaints and reporting as necessary to regulatory authorities, and will ensure compliance with regulations related to product approval and registration. Great opportunity with a respected and stable company that offers a competitive compensation and benefits package.  If this is for you or someone you know, please forward a current resume to tim@pointonerecruiting.com

 

Job Responsibilities-Compliance Engineer/Specialist:

·         Develops risk management content by understanding how requirements laid out in ISO 14971 and government regulations for risk management apply to company products and processes.

·         Documents risk management activities in the Hazard Traceability Matrix and Risk Management report, including inputs, FMEA, Risk Analysis, and Risk Control specifics.

·         Ensures post-market compliance by investigating alleged injury or litigious complaint allegations, and determining when there is a need to submit reports to government authorities.

·         Ensures documents are controlled by acting as a system administrator for Solidworks PDM document control software. Understand and communicate FDA document control requirements, maintain and ensure the current versions of documents are available in the correct format.

·         Influences product marketability by fulfilling business region and other customer requests for product registrations, and to gather data and evidence as needed to fulfill legal, regulatory, statutory, and market requirements.

·         Strengthens company operations by representing the compliance department as a team member for projects and engineering changes. Act as technical resource to Marketing for literature reviews (sell sheets etc.) 

  • Administers company-wide compliance by reporting to the Director of Quality and Regulatory compliance.
  • Maintains quality service by following established QMS and company policies and keeping error rates minimal and within acceptable ranges.

·                    

Job Requirements

Requirements and Experience-Compliance Engineer/Specialist

  • Bachelor’s Degree in engineering, management, or a field related to work area preferred or a combination of education and/or related experience. 2-7 years total experience is ideal range.
  • ISO 14971 risk management training certified is preferred.
  • Quality system internal auditor certification (ISO 13485) preferred.

Apply Now!  Send resumes to tim@pointonerecruiting.com

Job ID: TAB-Compliance-02
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