Sr. Quality Engineer

Duration - 1 Year, Contract, W-2

Location - Hybrid in Redmond, WA (1 day remote)

Pay - $50 - $56.66 an hr

The Sr. Quality Engineer will support manufacturing operations and supplier quality in a fast-paced, high-pressure environment. This role partners closely with Operations, Engineering, and suppliers to resolve quality issues, manage nonconformances, and ensure continuous improvement of products and processes.

Responsibilities

• Support manufacturing operations and supplier quality management
• Investigate nonconformances, CAPAs, and quality issues; perform root cause analysis and drive timely resolution
• Own and manage internal and supplier-driven NC and CAPA records using TrackWise
• Support investigations and disposition of nonconforming product, including MRB activities and line-down support
• Collaborate with Operations to restore production and ensure ongoing product and process quality
• Lead and support process improvements related to efficiency, throughput, and equipment
• Own PPAPs for supplier changes and support change management activities
• Communicate with suppliers on quality issues, including escalation of SCARs and management of SICRs
• Support manufacturing transfers, supplier qualification, and supplier part certification efforts
• Participate in process, equipment, and validation reviews, including MSA and KPI monitoring
• Review and support validation protocols, reports, change orders, labeling, and quality documentation
• Perform other related duties as assigned

Qualifications

• Engineering or science degree (BS preferred)
• Medical device experience or regulated manufacturing environment experience
• Background in bioscience/lab work and/or manufacturing floor experience preferred
• Strong root cause analysis and problem-solving skills
• Comfortable working in fast-paced, time-sensitive situations
• Strong communication skills with the ability to influence cross-functional stakeholders
• Able to work independently and collaboratively
• Naturally curious, detail-oriented, and execution-focused
• Strong technical thinking, stakeholder management, and execution speed
• Proven ability to translate lab or technical experience into manufacturing quality work

Quality Tools & Experience

• TrackWise (nonconformances, CAPAs, complaints)
• MasterControl (document management)
• SAP (order management, holds, manufacturing systems - trainable)
• PPAP, validation, DFMEA/PFMEA, control plans, process flow diagrams
• Ability to define requirements and collect objective evidence

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.