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Quality Engineer, Sustaining Product Quality, Level 2

Company: Orchid Orthopedic Solutions
Location: Santa Ana
Posted on: May 3, 2021

Job Description:

SUMMARY OF POSITIONThe Quality Engineer, Sustaining Product Quality supports the ongoing quality of Orchid's legacy products. This position reports directly to the site quality leader and works with team members in quality, manufacturing, and operations. The Quality Engineer, Sustaining Product Quality, Orchid Santa Ana will report to the Manager, Quality, Full-Site Leadership and be part of the Quality team. This position works alongside other Engineers in Quality and Manufacturing Engineering as well as the site's operations team.SHIFTNo Shift ($0) (United States of America)WHAT YOU WILL DOUses quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validationConducts special process validations and equipment validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.Analyzes statistical data and product specifications to determine standards and establish quality and reliability objectives for Orchid.Develops inspection criteria that correlate customer requirements and manufacturing processes that include identification of characteristics, sampling plans, and gauging. This also includes the guidance into the control plans and will be the final reviewer for all control plan documentation.Monitors production processes and products for adherence to company and regulatory standards and practices. Participates in quality improvement initiatives and projects.Performs quality reviews and internal audits; evaluates data and writes reports to validate or indicate deviations from existing terfaces with appropriate customer contacts to clarify customer requirements to include cosmetic specifications.Acts as a customer liaison and processes customer quality complaints.Reviews and approves change requests.Recommends modifications to existing quality or production standards to achieve optimum quality within limits of equipment capability.Participates in pre- and post-production reviews providing quality engineering support.Collects the required data and chart the quality goals established by the management team.Supports measuring and analyzing key metrics to monitor performance.Leads productivity improvements by providing quality guidance.Support quality and compliance by utilizing One Orchid global processes and complying with all Quality Management Systems (QMS) documentation requirements and establishing/supporting plan(s) to meet/exceed Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.WHAT WE ARE LOOKING FORWORK EXPERIENCE 3+ Years of Experience (Required), 5+ Years of Experience in a Manufacturing Environment (Preferred), Experience in Medical Device Manufacturing (Preferred) EDUCATION Bachelor of Science (B.S) - Engineering Required, , , CERTIFICATIONS Certified Quality Auditor (CQA) - American Society for Quality (ASQ), Certified Quality Engineer (CQE) - American Society for Quality (ASQ), Certified Reliability Engineer (CRE) - American Society for Quality (ASQ), GD&T - AnyKNOWLEDGE & SKILLS THAT ENABLE SUCCESSAccuracy and Attention to Detail (Working Experience), Communication (Basic Knowledge), Computer Knowledge (Working Experience), Final Inspection (Working Experience), Lean Manufacturing (Working Experience), Manufacturing Safety (Working Experience), Operational Functions (Working Experience), Problem Solving (Working Experience), Process Management (Working Experience), Production Part Approval Process (PPAP) (Working Experience), Production Runs (Extensive Experience), Quality Management (Working Experience), Statistical Analysis and Measurement (Working Experience)WHAT WE OFFEROpportunity to work in a growing companyAbility to help people live a longer, more active lifeComprehensive benefit packageAbility to work in an organization that values:Integrity First: We do the right thingTeamwork: We are one OrchidResults: Our results matterPHYSICAL REQUIREMENTSOccasionally moves heavy equipment, boxes, and other materials and tools.Requires sitting and standing for long periods of timeConstantly operates a computerFrequently inspects and places partsADDITIONAL REQUIREMENTSCandidates offered employment must submit to a pre-employment background check and pre-employment drug testCandidates must be able to provide proof of eligibility to work in the United States through eVerify EOE, including disability/vetsPosition:Quality Engineer, Sustaining Product Quality, Level 2Company:Orchid Orthopedic SolutionsJob Location(s):Santa Ana, CAStart Date:As soon as possibleEmployment Term:RegularEmployment Type:Full TimeStarting Salary Range:Not ProvidedRequired Experience:OpenRequired Security Clearance:NoneRelated Categories:Engineering - General, Quality Assurance/Safety, Engineering - Electrical

Keywords: Orchid Orthopedic Solutions, Santa Ana , Quality Engineer, Sustaining Product Quality, Level 2, Other , Santa Ana, California

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