Associate Quality Engineer

About the Role

The Associate Quality Engineer will be responsible for achieving the highest quality level of manufacturing quality and quality system performance, ensuring compliance with company policies, procedures, US FDA and international medical device regulations, and ISO 13485 quality system requirements. This role involves maintaining and improving the quality management system, product quality, and manufacturing process quality.

Key Responsibilities

• Provide real-time quality support to manufacturing operations.
• Assist in identifying defects, performing root-cause analysis, and implementing corrections/corrective actions.
• Support defect reduction initiatives and process capability improvements.
• Lead the containment, risk-based evaluation, disposition, and closure of Nonconforming Material records.
• Facilitate Material Review Board (MRB) activities by preparing data, coordinating cross-functional input, and ensuring timely documentation.
• Lead the collection, analysis, and reporting of quality system data to assess device performance, detect quality trends, maintain end-to-end traceability, and ensure compliance.
• Support timely execution of CAPAs, ensuring proper documentation, risk assessment, and effectiveness verification.
• Collaborate with cross-functional teams to maintain CAPA compliance and prevent recurrence of issues.
• Support the development, implementation, and improvement of production monitoring methods and systems for product inspection and testing.
• Perform measurement systems analysis.
• Conduct thorough review of documentation, including Document Change Orders (DCOs), engineering drawings, specifications, risk management files, and Verification & Validation (V&V) protocols and reports.
• Ensure documents meet regulatory, procedural, and quality system requirements, reflecting appropriate risk controls and traceability.
• Support the validation of manufacturing processes, including IQ, OQ, and PQ.
• Assess Supplier documentation, including Certificates of Conformance, First Article Inspections, supplier process validations, quality agreements, and supplier responses to SCARs.
• Verify that all documentation changes are properly justified, risk-assessed, and approved through the appropriate change control process.
• Collaborate with cross-functional partners to clarify requirements, close gaps, and drive timely approval of documentation packages.
• Assist in preparation for external and internal audits by organizing documentation, gathering objective evidence, and responding to auditor requests.
• Support timely closure of audit observations.
• Utilize concepts of probability and statistical quality control to guide decisions.
• Establish, follow, and improve company procedures.
• Provide written and oral reports to supervisor or other management personnel.

Requirements & Tech Stack

• US FDA regulations
• ISO 13485
• Nonconforming Material records
• Material Review Board (MRB)
• CAPAs
• measurement systems analysis
• Document Change Orders (DCOs)
• Verification & Validation (V&V)
• IQ, OQ, PQ
• First Article Inspections
• SCARs
• probability and statistical quality control
• Lean Manufacturing (basic understanding is a plus)
• Six Sigma (basic understanding is a plus)
• reliability engineering (basic understanding is a plus)

Qualifications

• Bachelor’s Degree (science or engineering preferred)
• 0-2 years’ experience in quality assurance
• Experience in the medical device industry preferred
• Experience supporting machine learning initiatives by creating high-quality training datasets, evaluating model outputs, and driving continuous performance improvements
• Team player capable of working in a deadline dictated environment
• Excellent verbal and written communication skills
• Self-starter
• Advanced critical thinking and problem-solving skills