Quality Engineer

The Quality Engineer independently leads technical quality engineering and validation activities supporting new product development, sustaining engineering, manufacturing, and quality system compliance. The role serves as a Quality representative on cross-functional teams and applies validation, design controls, risk management, statistical methods, and structured problem-solving to ensure products and processes meet applicable regulatory, quality system, and customer requirements.

• ◆Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems, including software.
• ◆Prepare comprehensive validation reports and analyze and interpret validation data to identify trends, anomalies, and areas for improvement.
• ◆Ensure validation activities comply with regulatory

and organizational/industry standards.

• ✓Serve as the Quality Engineering representative for new product development, sustaining engineering, verification and validation, risk management, and design or process changes, including review and approval of applicable technical documentation.
• ✓Lead or provide technical support for investigations involving nonconformances, complaints, CAPAs, and supplier or manufacturing quality issues, including root cause analysis, corrective action development, and effectiveness assessment.
• ✓Apply quality engineering and statistical tools, including DOE, FMEA, capability analysis, sampling plans, and trend analysis, to assess risk and improve products, processes, inspection methods, and control strategies.
• ✓Lead technical supplier quality support for qualification, audits, validations, change assessments, and evaluation of supplier corrective action responses, while routine SCAR administration and supplier monitoring remain within Quality Systems.
• ✓Participate in regulatory, notified body, customer, corporate, and internal audits by providing technical documentation and evidence-based responses within the role’s areas of responsibility.
• ✓Partner with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to ensure quality

are appropriately incorporated and maintained throughout the product lifecycle.

• ✓Provide technical guidance to less experienced Quality Associates and support assigned departmental quality and continuous improvement initiatives.
• ✓Follow departmental Standard Operating Procedures, Work Instructions, and applicable safety requirements.

Incidental Duties: The above statements describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all duties. Additional

may be assigned by management, as required.

Job

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and function effectively in a fast-paced environment where priorities may change. The

below are representative of the knowledge, skill, and ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• ✓Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering, or a closely related engineering field.
• ✓Typically 2–5 years of quality experience in a regulated industry, preferably in medical devices.
• ✓Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system

in manufacturing.

• ✓Quality Engineer certification or another relevant professional certification preferred.

• ✓Working knowledge of applicable medical device quality system requirements, ISO, GMP requirements, and relevant international standards.
• ✓Ability to independently interpret and apply regulatory, quality system, technical, and customer

and resolve complex quality issues using structured problem-solving.

• ✓Proficiency in statistical analysis and data interpretation, including practical applications of DOE, FMEA, capability analysis, and sampling methods.
• ✓Strong technical writing, project leadership, organization, and cross-functional communication skills.
• ✓Ability to understand product applications, specifications, functionality, assembly, manufacturing processes, and test methods.
• ✓Microsoft Office skills and the ability to quickly learn eQMS, ERP, and other business systems; experience with MasterControl, Oracle, or comparable systems preferred.
• ✓Ability to manage multiple priorities with minimal oversight, adapt to changing business needs, communicate effectively in English, and travel as required.