Job Description

Job Description

Job Description

ORGANIZATIONAL STATUS:

The Quality Engineering and Regulatory Affairs Intern is appointed by, receives authority from, and reports to the Quality and Regulatory Affairs Manager.

POSITION SUMMARY:        

The QA/RA Manager provides hand-on experience in Regulatory Affairs and Quality Management Systems. This includes projects and daily tasks associated with maintaining compliance with domestic quality system as required for Medical Device Manufacturers involved with Clean Room Operations, and through support of other functional departments or product staff in assisting the QA/RA Manager. This is a full-time position running approximately mid-May 2026 – mid-August 2026.

RESPONSIBILITIES:

The duties & responsibilities of the Quality Engineering and Regulatory Affairs Intern include but are not necessarily limited to:

• Assisting the QA RA Manager with Regulatory Activities, Corporate Quality, oversight of Plant Quality, Microbiology/Sterilization and Document Control
• Participating in the development and execution of installation, operational and performance qualifications of equipment, (IQ, OQ and PQ) including the clean room itself.
• Prepares quality documentation (ERTs, CRTs and Management Review) and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.

Skills/Qualifications:

EDUCATION AND EXPERIENCE

• Minimum of high school education & completed one year of college minimum, and actively pursuing a bachelor’s or master’s degree in engineering, quality, regulatory, life sciences, or similar degree program.
• Excellent communication skills (written and verbal)
• Proficiency with Microsoft Office

Employment at Exsurco Medical is contingent upon successfully completing both a pre-employment background check and a drug screening. All candidates hired must be able to provide proper documentation of their eligibility to work in the US (I-9 form). Exsurco Medical is an Equal Opportunity Employer – Minorities / Females / Disabled / Veterans (M/F/D/V).

PERSONAL CHARACTERISTICS:

• Behave Ethically: Understand ethical behavior and business practices and ensure that behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.
• Communicate Effectively: Speak, listen and write in a clear, thorough and timely manner using appropriate and effective communication tools and techniques.
• Creativity/Innovation: Develop new and unique ways to improve function efficiency and performance.
• Foster Teamwork: Work cooperatively and effectively with others to set goals, resolve problems, and make decisions that enhance process effectiveness.
• Organize: Set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.
• Plan: Set goals, create and implement actions plans, and evaluate the process and results.
• Solve Problems: Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations to manager.

Values:

• Courage: To seek ownership and think big, embrace change and make bold decisions.
• Creative: To apply our individual skills to make a difference.
• Authentic: To act with trust, respect, integrity, and shared risk.

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