Quality Assurance Specialist

Role Overview

• Analyze and investigate reported quality issues in accordance with company guidelines and external regulatory requirements.
• Maintain and analyze problem logs to identify and report trending or recurring issues to Quality Assurance Management.
• Issue Supplier Corrective Action Requests and work closely with suppliers and internal teams on their resolutions.
• Coordinate Supplier Qualification process by assessing supplier risk and maintaining supplier questionnaire, agreement, and other related documentation.
• Assist in updating company Quality Management System procedures to ensure proper process workflow and documentation.
• Work closely with internal departments for resolution of complaints and any CAPA resulting from quality issues.
• Assist in internal and Regulatory audits as required.
• Assist in other Quality Assurance tasks as required.

Requirements

• Bachelor or higher degree in science or related field
• 2 + years experience in a regulated manufacturing environment (medical devices, aerospace, communications, automotive, etc. )
• Familiarity with FDA QSR and ISO Requirements
• Familiarity with ServiceMax and 123Compliance a plus
• Detail-oriented with good analytical ability and problem-solving skills
• Ability to work independently and efficiently and work well with others
• Good organizational and communication skills (verbal and written)
• Ability to follow detailed written procedures; handle multiple tasks simultaneously and prioritize accordingly.

Benefits

• medical, dental, vision, life insurance
• disability insurance
• tax saving spending accounts
• 401(k) plan with employer match
• tuition reimbursement
• time off for our employees to recharge
• paid company holidays
• paid personal time off
• paid sick time