Quality Engineer, Operations

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.

Key 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.

Qualifications:

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. Related Master's Degree or internships may also be considered as part of experience. 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. 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. Salary range is $90k-$115k per year which is the general base range for a successful candidate in the State of Washington. The successful candidate's actual pay will be based on various factors such as skills, qualifications and experience. This role is also eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits. MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law. Please note that only qualified candidates will be contacted for further consideration. #MST #LI-JC6 Not the right fit? Let us know you're interested in a future opportunity by clicking Introduce Yourself in the top-right corner of the page or create an account to set up email alerts as new job postings become available that meet your interest!