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Role Description

The Quality Assurance Specialist leads and provides support to investigations involving Complaints, Corrective and Preventive Actions (CAPA), and nonconformance to ensure our processes meet regulatory and Quality Management System requirements. We are looking for an individual who is detail-oriented with effective communication and strong analytical skills who enjoys cross-functional collaborations. Your work will directly contribute to compliance, continuous improvement, and operational excellence in the company.

• 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 maintain 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.

Qualifications

• Bachelor or higher degree in science or related field
• 2+ years experience in a regulated manufacturing environment (medical devices, aerospace, communications, automotive, etc.)

Requirements

• 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

• Comprehensive benefit package including medical, dental, vision, life insurance, disability insurance, tax saving spending accounts
• 401(k) plan with employer match
• Tuition reimbursement
• Paid company holidays, paid personal time off, and paid sick time that meets or exceeds state/local requirements

EEO Statement

We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.