Quality Engineer

Role Overview

• The Quality Assurance Engineer ensures compliance to existing procedures and regulations through document review, audits and facilitation of risk management, data trending and root cause analysis.
• Analyzes production limitations and problems and facilitates root cause analysis.
• Analyzes data to bring conclusion to production and quality management.
• Reviews change orders for product releases/updates and production material and process changes.
• Conducts and documents internal non-conformance and customer complaint investigations.
• Support in Medical Device reporting (MDRs), complaints, field corrective action (Recall) and management review meeting.
• Effectively engage in projects as the Quality Engineering resource.
• Formulates or assists in formulating quality standards, policies, programs, plans, procedures, and practices.
• Assesses and approves product and process validation activities.
• Performs such individual assignments as supervisors and superiors may direct.
• Ensures adequate and continuous controls are exercised over all assigned activities affecting quality.
• Establishes and maintains effective work relationships.
• Maintains the professional competence, knowledge, and skill necessary for the satisfactory performance of all assigned responsibilities.
• Facilitates the completion of Risk Analysis documentation for new and existing products/processes.
• Organize and conduct internal and supplier audits.
• Initiates and manages Corrective/Preventative actions based on data review and input from outside sources and internal data analytics.
• Serves as quality contact during customer and notified body audits.

Requirements

• Able to read and understand engineering design drawings technical plans and reports
• Possess knowledge and hands-on experience with ISO quality system standards ISO 13485, ISO 14971, and FDA 21 CFR 820
• Auditing education and experience
• Ability to work effectively with various work groups to assure conformance to quality and regulatory requirements internal processes and policies
• Ability to prioritize tasks in deadline driven environment
• Strong written and verbal communication and organizational skills

Benefits

• Competitive Compensation
• Excellent Benefit Package (medical, dental, vision insurance, paid time off, disability insurance, 401k, tuition reimbursement and much more)
• Solid Stable Company
• Commitment to sustainable design