Quality Engineer II

What You’ll Do

• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, sanitation, facilities, software, and processes.
• Collaborate with customers on equipment and process validations.
• Serve as the database administrator for Infinity QS (Statistical Process Control) software.
• Provide statistical analysis support for manufacturing, new product development, trials, and validations.
• Develop SOPs related to validation and risk management.
• Monitor and prepare Key Performance Indicators (KPIs) for major customers.
• Lead Corrective Action/Preventative Action (CAPA) activities and facilitate root cause investigations.
• Train associates on quality topics such as SPC and CAPA.
• Drive continuous improvement initiatives with internal teams and external partners.

What We’re Looking For

• Education & Experience Requirements:
• Bachelor’s degree in Engineering, Science, or related field.
• 3+ years of engineering experience, preferably in manufacturing.
• Technical Expertise:
• Background in nutritional products, medical devices, pharmaceuticals, or similar industries.
• Experience in FDA-regulated environments.
• Experience with validations.
• Skills:
• Strong problem-solving and root cause analysis capabilities.
• Ability to work independently and collaboratively in a fast-paced setting.
• Flexible schedule to support production and validation activities.

Why Join Iatric?

• Impact: Play a critical role in ensuring product safety and compliance in industries that matter.
• Culture: Work in an environment that values integrity, teamwork, and continuous improvement.
• Growth: Opportunities for professional development and leadership in a growing organization.
• Innovation: Be part of a company that invests in technology and quality to deliver best-in-class products.

Benefits

• Health & Wellness: Medical, dental, vision coverage, wellness programs, and fitness reimbursement.
• Financial Security: Retirement savings with company match, life and disability insurance, and optional supplemental coverage.
• Career & Lifestyle: Paid time off, education reimbursement, and employee discount programs.
• Mental Health Support: Confidential counseling and resources for personal and work-life needs.