Quality Engineering Internship

Team info:

The new hire is going to be a part of the Quality Systems Team assisting in implementing and managing design controls. The Quality Engineering Intern is responsible for assessing, establishing, and maintaining effective Design Control disciplines to ensure alignment of FDA Part 820.30 and ISO 13485 standards within the quality systems. Provide guidance and collaborate across departments to identify gaps and show ownership with a hands-on approach in driving solutions to address any identified Design Control (ISO-13485/CFR 820) gaps or remediation needs.

Job Responsibilities:

• Review and assess DHF and Design Control records to ensure compliance with the state-of-the-art design control requirements per 21 CFR 820.30.
• Bring hands-on solutions and improvements to Design Control Records.
• Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance, and standards.
• Collaborate with cross-functional teams to address QMS noncompliance and develop remediation plans.
• Provide training and structure as needed for key Design Control (ISO 13485, CFR 820) elements.
• Generate, edit, and maintain QMS documentation, including but not limited to, departmental documents, procedures, work instructions, templates, and training materials including change control.
• Review verification and validation reports and identify gaps for compliance to internal quality requirements.

Key qualifications:

• Undergraduate degree in an engineering discipline, OR currently pursuing a graduate degree in a STEM field. 
• Must have strong written and oral communication skills, and enjoy independent learning, doing research, and presenting on a wide variety of topics.
• A strong understanding of design controls and engineering first principles. 
• Enjoys working in a collaborative environment with a mission first, go-getter attitude

Preferred qualifications:

• Experience of 0-2 years in FDA-regulated industry (Medical Devices or Biotechnology
• Experience of 0-1 year in Design Controls.