Quality Engineer, Operations

Halma•Redmond, WA

3d•$90,000 - $115,000•Onsite

About The Position

Help grow a safer, cleaner, healthier future for everyone, every day. Quality Engineer, Operations Microsurgical Technology Redmond, WA (On-Site) The Operations Quality Engineer is responsible for supporting and improving the quality and compliance of manufacturing operations within the organization. This role ensures that products are manufactured in accordance with applicable regulatory requirements, internal procedures, and customer expectations. This role serves as a key liaison between Quality, Manufacturing Engineering, R&D, Regulatory and Supply Chain to drive product quality, continuous improvement, and operational excellence.

Requirements

Bachelor’s degree in Mechanical, Biomedical, Industrial, or related Engineering discipline.
Minimum of 2 years of experience in the medical device industry, with a strong focus on quality engineering and regulatory compliance.
Knowledge of FDA QSR, MDSAP, EU MDR, ISO 13485, ISO 14971 and other relevant standards and regulations.
Excellent communication (both oral and writing) and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
Strong analytical and problem-solving skills.
Ability to collect and analyze data to identify trends and opportunities for improvement.
Proficiency in Microsoft Office applications, particularly Excel and PowerPoint.

Nice To Haves

Related Master’s Degree or internships may also be considered as part of experience.
PowerBI familiarity is highly desirable.
Familiarity with ERP, MES, eQMS, statistical analysis and/or project management software (i.e. ClickUp) is highly preferred.
Experience in statistical analysis techniques and tools highly preferred.

Responsibilities

Serve as Quality Engineering support for daily manufacturing operations.
Provide guidance to manufacturing/production on Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and compliance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulatory requirements.
Monitor in-process inspections and process control metrics; identify and implement improvements to reduce variation and improve yield.
Lead and/or support investigations for internal nonconformances and supplier-related issues.
Own or support Corrective and Preventive Actions (CAPAs).
Perform root cause analysis using appropriate problem-solving tools (e.g., 5-Whys, Fishbone Diagram, FMEA).
Lead or support validation activities (including IQ/OQ/PQ and GR&R) for new and existing manufacturing processes, equipment, and test methods.
Provide Quality input and assessments for change control activities.
Track and trend in-process quality indicators, yield, scrap, and rework rates.
Drive data-driven decisions to improve product and process performance.
Identify areas of risk and lead or support quality improvement initiatives to enhance compliance and efficiency.
Participate in internal and external audits (e.g., FDA, ISO, MDSAP) by providing documentation, responding to auditor inquiries, and supporting corrective action closure.
Performs other duties as necessary.