What are the responsibilities and job description for the Quality Engineer position at Beacon Engineering Resources?
Quality Engineer
Key Responsibilities
- Maintain and improve the Quality Management System (QMS) to ensure compliance and operational effectiveness
- Manage QMS processes including Audits, CAPA, Document Control, and Training
- Analyze quality data, identify improvement opportunities, and support corrective actions
- Prepare for and support external audits and inspections
- Collaborate cross-functionally on quality planning, risk management, validation, and training initiatives
Required Education & Experience
- Bachelor’s degree in Engineering, Science, Manufacturing, or related field
- 5 years of experience in Quality Systems, Compliance, or Auditing within a regulated environment
- EU MDR
Knowledge, Skills, & Abilities
- Strong knowledge of quality systems, regulatory compliance, and risk management
- Experience supporting audits and maintaining compliant processes
- Strong communication, analytical, and problem-solving skills
- Proficiency with Microsoft Office applications
Preferred Qualifications
- Project management experience
- Lead Auditor or Quality Auditor certification
- Experience with software lifecycle or validation requirements
- Familiarity with international regulatory standards
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off