Quality Systems Engineer

Span-America Medical Systems Inc • Maryland Heights, MO

4d • Onsite

About The Position

The Quality Engineer defines, implements, and maintains effective quality systems in accordance with FDA Quality Systems Regulation, ISO 13485, and other applicable country-specific regulations. The position has authority to approve quality system documentation, including nonconformance reports, procedures, work instructions, and corrective action reports. It is 100% onsite at 10888 Metro Ct., Maryland Heights, Missouri, and may require travel up to 25% of the time. The position has no supervisory responsibilities.

Requirements

• Bachelor’s degree in Engineering, Mathematics, or Science, and 8 to 10 years of quality experience with medical devices in an FDA- and/or ISO-regulated industry, or an equivalent combination of education and experience.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to read, analyze, and interpret business publications, professional journals, safety rules, technical procedures, and government regulations.
• Ability to write reports, business correspondence, and procedure manuals, and to present information and respond to questions from managers, clients, customers, and the public.
• Clear and persuasive verbal communication and clear, informative writing.
• Attention to spelling, grammar, accuracy, and thoroughness.
• Ability to follow policies, procedures, instructions, and management direction; observe safety and security procedures; understand the business implications of decisions; identify quality improvements; and determine appropriate action beyond guidelines.

Nice To Haves

• Intermediate proficiency with statistical software packages such as MiniTab.

Responsibilities

• Develop, implement, maintain, and monitor facility quality metrics.
• Document quality systems and programs, including quality trends, training, corrective and preventive actions, process control, and customer complaints, to ensure compliance with FDA and other regulatory requirements.
• Verify corrective actions are effective and eliminate repeat failures.
• Lead regulatory inspections, ISO audits, and customer audits.
• Support the Internal Audit Program, participate in scheduled internal audits, and review audit results to ensure noted deviations are resolved.
• Implement inspection and audit programs in manufacturing.
• Perform additional duties as requested or required.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior