Quality Engineer
About The Position
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. The position involves developing and executing validation protocols for equipment, processes, and systems, analyzing validation data, supporting investigations and supplier quality activities, and contributing to audits and continuous improvement. The Quality Engineer partners with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems throughout the product lifecycle, and provides technical guidance to less experienced Quality Associates.
Requirements
- 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.
- Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in manufacturing.
- 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 requirements 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 ability to quickly learn eQMS, ERP, and other business systems.
- Ability to manage multiple priorities with minimal oversight, adapt to changing business needs, communicate effectively in English, and travel as required.
- Ability to perform the essential duties satisfactorily and function effectively in a fast-paced environment where priorities may change.
Nice To Haves
- Quality Engineer certification or another relevant professional certification.
- Experience in the medical device industry.
- Experience with MasterControl, Oracle, or comparable systems.
Responsibilities
- Develop and execute IQ, OQ, and PQ validation protocols for equipment, processes, and systems, including software.
- Prepare validation reports and analyze and interpret validation data to identify trends, anomalies, and improvement opportunities.
- Ensure validation activities comply with regulatory requirements and organizational and industry standards.
- Represent Quality Engineering on new product development, sustaining engineering, verification and validation, risk management, and design or process change activities, including reviewing and approving 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.
- Provide technical supplier quality support for qualification, audits, validations, change assessments, and evaluation of supplier corrective action responses.
- Participate in regulatory, notified body, customer, corporate, and internal audits by providing technical documentation and evidence-based responses within areas of responsibility.
- Partner with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to incorporate and maintain quality requirements throughout the product lifecycle.
- Provide technical guidance to less experienced Quality Associates and support departmental quality and continuous improvement initiatives.
- Follow departmental Standard Operating Procedures, Work Instructions, and applicable safety requirements.
Benefits
- Annual performance bonus may be included in the total compensation package.
- Medical, dental, and vision benefits may be included in the total compensation package.
- 401K match may be included in the total compensation package.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
