Job Title:  Quality Assurance/Regulatory Affairs Intern

Hours: 8:00 AM to 4:30 PM
Department: QARA

POSITION SUMMARY

As a Quality Assurance & Regulatory Affairs Intern, you will play a crucial role in supporting our compliance efforts with ISO 13485:2016 and Quality System Regulations (QSR) for Medical Devices. This internship offers a unique opportunity to gain hands-on experience in the Medical Device industry, working closely with experienced professionals in Quality Assurance and Regulatory Affairs (QARA). You will participate in quality assurance activities such as investigating non-conformances, implementing corrective and preventive actions (CAPAs), and supporting quality improvement initiatives. You will also have the chance to attend training sessions and stay updated on the industry’s best practices and regulatory changes. This role requires a detail-oriented individual with strong organizational skills and a keen interest in regulatory affairs and quality assurance. You will have the opportunity to work independently and as part of a team, gaining valuable experience that will enhance your career prospects in the Medical Device industry.

KEY RESPONSIBILITIES

• Assist in the creation and review of quality-controlled documents such as standard operating procedures, work instructions, and forms.
• Support quality system processes for document control, training, electronic approvals, calibration, complaints, etc.
• Initiate and assist with nonconformance and CAPA records, including investigations.
• Participate in internal and external audits and support remediation actions.
• Assist in the creation of quality related training.
• Collaborate with cross-functional teams to ensure compliance with regulatory standards.
• Support and develop validation protocols.
• Review and re-organize historical validation reports.
• Support complaint and post-market surveillance activities.
• Monitor changes in regulatory requirements and assist in updating company policies and procedures accordingly (i.e. FDA Medical Device Cybersecurity, QMSR).
• Perform data collection and trending analysis and prepare summaries.
• Support Patient Station Field Action follow-up and closure (product returns, documentation, file organization, etc.).
• Assist with customer and regulatory agency requests regarding international reporting information.

PREFERRED REQUIREMENTS FOR CONSIDERATION

• Currently pursuing a degree in Science, Biomedical Engineering, Regulatory Affairs, Quality Assurance, or a related field.
• Strong analytical skills and attention to detail.
• Excellent communication and interpersonal skills.
• Proficiency with computer programs including, but not limited to MS Office (Excel, Word, Outlook, etc.).
• Basic knowledge of medical device regulations and standards (QSR and ISO 13485:2016).

Why Us?

Rauland is a business unit in the Measurement, Communications and Technologies division of AMETEK. We are a leader in integrated communications technology, designing and manufacturing Nurse Call Systems for the medical industry and school critical communication systems for the education K-12 market. A pioneer and an innovator, Rauland has been setting new standards for integrated communications technology and service for more than 80 years.  From our headquarters in Mount Prospect, Illinois, we’ve built a solid reputation for our dedication to quality design, manufacturing and customer service. 

Website: www.rauland.com