Quality Assurance Engineer (Columbus, Ohio)

About our Client & the role:
Our products comply with applicable regulatory requirements as established by ISO 13485, U.S. Food & Drug Administration (21 CFR Part 803, 806, 820), MDR 2017/745, CMDR registered Quality Management Systems.  The person in this position will work closely with the VP of Product Development to ensure that the quality system is implemented, monitored and maintained in accordance with all applicable regulatory requirements.  

Two will be hired.  All in all,  Quality Systems in place could be better, could be implemented better, and new leadership is passionate about achieving!   

Responsibilities:
Assist in the maintenance of an effective Document Control Management system, including relevant Standard Operating Procedures (SOPs) and Work Instructions (WIs) for the proofing, filing, copying, scanning, archiving, retrieval, and maintenance of all controlled documents and records required by applicable regulations.
Manage the Quality Assurance Processes to be followed in the event of a complaint, deviation, CAPA, recall or field action per 21 CFR 803, 806, 820 and ISO 13485.  Coordinate and participate in investigations.  
Ensure adequate follow-up through the implementation of corrective and preventative actions (CAPA) as required.
Manage risk assessments and follow-up activities and ensure visibility for potential risks.
Monitor and audit recall/field action activities to assure compliance with Standard Operating Procedures related to corrective actions, CFR requirements and customer complaints. 
Strengthen quality awareness throughout the organization, support technical services and process improvements.  Eliminate barriers and proactively investigate quality issues using appropriate process improvement and problem-solving techniques. 
Develop and maintain quality-related training programs and ensure implementation to minimize business risks.
Define and implement training system for employees related to the Quality Management System and job-related skills.
Provide Quality support to members of leadership team especially during audits and inspections.
Develop Quality metrics and goals; lead efforts related to the company’s quality vision.     
Ensure that QA activities are properly staffed, operate in a cost-effective manner, and maintain an innovative approach based on productivity improvement and implementation of best practice. 
Work with Manufacturing and R&D to ensure that products are developed and produced according to applicable regulations and standards. 
Ensure timely product disposition in compliance with all applicable regulatory and legislative requirements. 
Maintain database(s) or spreadsheet(s) for the worldwide regulatory status of products.
Assist in the development and implementation of regulatory strategies and prepare FDA (IDE, 510k, PMA, 513G) and international submissions (CE Mark, TGA, CMDR, etc.) for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards, and guidance.
Maintain systems for labeling, promotional material, change control, and the documentation for these systems as required by domestic and foreign governments.
Monitor industry and regulatory trends to develop strategy and provide guidance related to these trends.
Advise technical, marketing, and sales personnel on regulatory requirements (e.g. Design Controls, CE Marking, IDE, IRB, Labeling, and Promotion).

Preferred  Qualifications:
Medical Device Manufacturing background.
Excellent quantitative and analytical skills.
Ability to prioritize tasks in a fast-paced environment.
Strong written and oral communication skills are required.
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Bachelor’s Degree or higher in engineering or related field preferred.
Knowledge of 21 CFR 803, 806, 820, ISO 13485 and all applicable requirements and regulations to support the manufacture and distribution of medical devices. Medical Device / FDA Experience. 

Desire to be a part of a team ensuring  medical devices are safe, high quality, and compliant with FDA regulations.

Drive- to be curious, to want to be better, to Investigate product issues and customer complaints, help fix problems, maintain quality documentation, support audits and inspections, and work with engineering and manufacturing teams to ensure products are designed and built correctly. Be curious and passionate about making sure suppliers are happy and compliant, products are the absolutely best they can be!

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