Senior Quality Coordinator

ABOUT USOrchid Orthopedic Solutions is world leading Medical Device Contract Design and Manufacturing company that offers a comprehensive portfolio of services for implants and instruments with significant experience in the joint reconstruction, spine, trauma, dental and sports medicine markets.  Established in 2005 with a roll-up of best-in-class medical device suppliers with 120 employees.  This site specializes primarily in Swiss style turning (straight flute cutting tools and bone & plate screws).  We are also FDA registered and ISO 13485 certified.   A career with Orchid provides training and growth opportunities, great benefits, including quarterly bonuses, insurance, 401(k) with company match, paid time off and employee engagement events. For more information, please visit .SHIFTNo Shift ($0) (United States of America)A BRIEF OVERVIEWThe Senior Quality Coordinator maintains quality systems, ensures training is performed and recorded as required, and serves as a resource to the Quality and Regulatory functional groups at Orchid Santa Ana.WHAT YOU WILL DOManages the Corrective and Preventive Actions (CAPA) SystemCoordinates internal audits of the quality systemProvides quality system training to new employees and conducts ongoing refresher training for existing employeesCoordinates the nonconformance process and runs Material Review Board meetingsSupports Quality and Engineering staff with activities such as product quarantineManages the calibration processMonitors site quality metricsServes as local process owner for MQ1, EtQ, and Compliance WireSupports the Management Review process to ensure ongoing compliance and effectiveness of the Orchid QMS which may require preparing meeting minutes/PowerPoint and tracking action itemsSupports Quality and Engineering staff with ballooning new or revised drawingsSupports creating/updating inspection checklistsManages the intake and processing of complaints.Processes and reviews document creation/change requestsAssists document owners with writing, editing and training of new and revised proceduresAssists with coordinating, tracking, and recording trainingTracks and trends quality metricsParticipates in internal and/or external Inspections, as requiredVerifies employee training is current and completeAssists with Document Control activities (including, but not limited to: closing jobs in Enterprise Resource Planning (ERP) system, scanning documentation, Device History Record (DHR) reviews)Leads CAPAs and audit finding corrections related to the QMSEDUCATION QUALIFICATIONSHigh School Or Equivalent (Required)EXPERIENCE QUALIFICATIONS2+ Years of Experience in Quality (Required)3+ Years of experience with quality systems in a highly regulated industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)Experience utilizing basic blueprints (Preferred)Experience using Microsoft Excel, Word, and Powerpoint (Required)KNOWLEDGE & SKILLS THAT ENABLE SUCCESSAccuracy and Attention to Detail - Working ExperienceData Analysis Tools - Working ExperienceISO 9001 (Quality Management) - Basic KnowledgeOrganization - Basic KnowledgeComputer Knowledge - Working ExperienceISO 13485 - Basic KnowledgePHYSICAL DEMANDSMust be able to remain in a stationary position - FrequentlyMust be able to move about the inside of the building - OccasionallyMust be able to communicate and exchange information with others - ConstantlyMust be able to distinguish and detect information such as writing and defects - ConstantlyPAY RATE"‹For positions located in California, pay for this job type falls within the following range and varies based on scope and complexity of job responsibilities.$30.24 - $53.80Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.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 matterADDITIONAL REQUIREMENTSCandidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirementsCandidates must be able to provide proof of eligibility to work in the United States through eVerifyAt Orchid, we fully support a diverse and inclusive workplace and we are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability.Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.

Created: 2025-04-09