Quality Engineer

Summary

Elephas, a Madison, WI-based biotechnology company, is seeking a highly motivated Quality Engineer to join our team. A successful candidate will have a bachelor’s degree and be pursuing a career in Quality Assurance or Regulatory Affairs.  This candidate will be self-motivated to learn, and comfortable in a fast-paced and highly collaborative environment.  As a Quality Engineer at Elephas you will support this rapidly growing business by partnering with team members from all workstreams as we build a robust Quality Management System.

Essential Duties and Responsibilities

• Have a commitment and passion for product compliance, quality, and safety
• Ability and desire to read, understand, and interpret regulations
• Work under the requirements of the FDA Quality System Regulation 21 CFR Part 820, and ISO 13485 Quality Management System - Medical Devices
• Help manage and continually improve our Quality Management System (eQMS)
• Draft Standard Operating Procedures (SOPs) based on requirements and regulations
• Be a QA/RA subject matter expert supporting Research, Development, and Operations Departments
• Support employee training activities
• Support product risk management activities and ensure quality and completeness of project design history files
• Provide quality support in the assessment and qualification of suppliers and materials
• Participate in audits (internal, external, supplier)
• Investigate quality events using root cause analysis tools
• Analyze process data to identify trends and areas for improvement

Education/Experience/Skills

• Bachelor’s degree in life sciences, engineering, biotechnology, or related sciences preferred
• 2-3 years of experience working in ISO 13485 and/or QSR environment
• Strong understanding of Good Documentation Practices
• Computer proficiency of Microsoft Office Suite
• Excellent verbal, interpretation, and written communication skills

We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.