Associate Quality Engineer

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 to prevent production delays and ensure consistent product quality

Facilitate MRB (Material Review Board) 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 with U.S. FDA and global medical device regulatory requirements

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.

Supports the development, implementation, and improvement of production monitoring methods and systems for product inspection and testing

Performs measurement systems analysis

Conduct thorough review of documentation, including but not limited to 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 and reflect appropriate risk controls and traceability.

Supports the validation of manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)

Assess Supplier documentation, including Certificates of Conformance, First Article Inspections, supplier process validations, quality agreements, and supplier responses to SCARs. Ensure suppliers provide adequate objective evidence and that documentation aligns with material, component, and product requirements.

Verify that all documentation changes are properly justified, risk‑assessed, and approved through the appropriate change control process

Collaborate with cross‑functional partners—Product Development, Operations, Supply Chain, Regulatory and Field Service—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.

Utilizes concepts of probability and statistical quality control to guide decisions

Establishes, follows, and improves company procedures

Provides written and oral reports to supervisor or other management personnel to keep them informed of activities and results. Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.

Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties