Senior Quality Assurance Engineer Jobs in USA, WA, Redmond | Rose International Job

Rose International

Redmond, WA

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JOB DETAILS

SALARY

$70–$75 Per Hour

JOB TYPE

Temporary

SKILLS

Analysis Skills, Change Management, Change Order Management, Change Requests/Orders, Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Design Failure Mode and Effects Analysis (DFMEA), Distribution Services, Document Management, Documentation Review, Equipment Validation, Manufacturing, Manufacturing Analysis, Manufacturing Operations, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Equipment, Order Management, Performance Metrics, Problem Solving Skills, Procedure Development, Process Failure Mode and Effects Analysis (PFMEA), Process Flow Diagram (PFD), Process Improvement, Process Validation, Production Part Approval Process (PPAP), Project/Program Management, Quality Assurance, Quality Engineering, Regulations, Regulatory Compliance, Requirements Management, Risk, Root Cause Analysis, SAP, SAP Administration, Team Player, Time Management, Trend Analysis, Validation Documentation, Validation Plan, Vendor/Supplier Management, Vendor/Supplier Selection

LOCATION

Redmond, WA

POSTED

28 days ago

Required Education: Bachelor's degree in engineering Required Experience/Skills: Project management Experience in working in a compliance risk situation Experience in interacting with regulatory agencies Naturally curious and investigative Strong root cause analysis experience Comfortable leading discussions and influencing stakeholders Able to work independently and collaboratively Strong communication skills, especially when explaining resolution plans Comfortable working in stressful, time-sensitive situationsPreferred Experience/Skills: Medical device experience (preferred, not required) Experience in a regulated industry PPAP (nice to have) Validation experience DFMEA / PFMEA Control Plans Process Flow Diagrams Ability to define requirements and collect objective evidenceTools & Systems Used: TrackWise – nonconformances, CAPAs, complaints MasterControl – document management SAP – order management, holds, manufacturing systems (SAP experience helpful but trainable)Senior Quality Engineer: Work closely with Operations and the business functions to ensure quality performance of product and processes. Non-Conformanceso Collaborate with Internal cross-functional and Supplier teams to address top quality issues.o Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.o Support execution and analysis of manufacturing related complaint investigations and product field actions.o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate. Supplier Activitieso Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.o Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification. Process Improvements/Validationo Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.o Participate in and potentially lead the creation and/or review of new or modified procedures.o Support the development and review of process and equipment validation/qualification and MSA of internal processes.o Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary. Perform other related duties as assigned.Role Overview The Quality Engineer supports both: Manufacturing operations, and Suppliers Key responsibilities include: Investigating nonconformances, CAPAs, and quality issues Performing root cause analysis Leading cross-functional problem-solving huddles Driving process improvements (efficiency, throughput, new equipment) This is a fast-paced, high-pressure environment, where multiple quality issues can arise at once. The QE must be able to pivot quickly, provide direction, and help get production back up and running.Key Skills & Traits Needed Naturally curious and investigative Strong root cause analysis experience Comfortable leading discussions and influencing stakeholders Able to work independently and collaboratively Strong communication skills, especially when explaining resolution plans Comfortable working in stressful, time-sensitive situationsManufacturing & Stakeholder Interaction Frequent interaction with:o Manufacturing operators (on the line and at their desk) o Engineering o Regulatory o Compliance o Suppliers Documentation & Validation Work The QE will review and/or support: Validation protocols and reports Process and equipment validation Label reviews Change orders Documentation reviews **Only those lawfully authorized to work in the designated country associated with the position will be considered.** **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.** Benefits: For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website. California Pay Equity: For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here. Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances. If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department. Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

About the Company

Rose International

Founded in 1993 by Sue Bhatia, Rose International is one of the nation's leading minority- and woman-owned providers of Staffing and Total Talent Solutions. We serve companies in all 50 states and employ thousands of people across the country.

COMPANY SIZE

2,500 to 4,999 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

https://www.roseint.com/

Senior Quality Assurance Engineer Jobs in USA, WA, Redmond | Rose International Job

Rose International

Redmond, WA

About the Company

Rose International

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