Associate Quality Engineer

The Associate Quality Engineer will be responsible for achieving the highest quality level of manufacturing quality and quality system performance while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. As a contributor to the quality engineering organization, this professional will be self-motivated and characterized as an excellent problem solver. This person will play an integral role in maintaining and improving the quality management system, product quality, and manufacturing process quality.

Essential Functions:

• 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

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:

• Bachelor’s Degree required (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

• Basic understanding of Lean Manufacturing, Six Sigma, and reliability engineering is a plus

• Must be a team player capable of working in a deadline dictated environment

• Excellent verbal and written communication skills

• Self-starter

• Advanced critical thinking and problems-solving skills

Physical Demands:

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl

• Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds

• Required to possess specific visions abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus