Medical Device Quality Complaint Specialist
Cypress HCM
Cypress HCM in Irvine, CA is seeking a detail-oriented Complaint Handling Specialist to support and manage medical device complaint activities, including intake, documentation, triage, investigation, regulatory assessment, and closure in alignment with internal procedures, FDA 21 CFR 820, and ISO 13485. You will log, track, and close complaints in the QMS, collaborate with cross-functional teams, and assist with MDR/vigilance reporting, audits, and continuous improvement efforts. #J-18808-Ljbffr Cypress HCM
- ...Job Description Job Description OrthAlign, Inc. , a Smart Technology, growing medical device company, has an immediate opening for a Quality Systems Complaints Specialist. The Quality Systems Complaints Specialist determines the legitimacy of complaint feedback and...ComplaintsMedical deviceLocal areaImmediate start
$30 - $40 per hour
...Quality Specialist, Manufacturing, Garden Grove, CA $30.00 - $40.00 per hour... ...certification, calibration, complaint handling, CAPA (Corrective... ...gauges and other measurement devices; knowledge of inspection techniques... ..., pharma, biopharma or medical devices, aerospace is...ComplaintsMedical deviceHourly payTemporary workLocal areaFlexible hoursNight shift$89.4k - $148.9k
...DoSupport the ongoing manufacturing of medical devices by designing, documenting, and improving... ...operations that ensure product safety, quality, and performance.Lead process... ...disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation...ComplaintsMedical deviceFull timeFor contractors$80k - $100k
...Masimo Corporation in Irvine, California, is seeking a Clinical Complaint Specialist responsible for clinical assessment and processing of medical device complaints. This role involves evaluating complaint events, determining regulatory reportability, and collaborating...ComplaintsMedical deviceWork at office$126k - $138k
...execute, and report on internal quality system audits in accordance... ...& process controls, CAPA, complaint handling, supplier quality, document... ...sterilization, and clinical device release. Author audit... ...Quality Assurance within the medical device industry. Minimum 5...ComplaintsMedical deviceRelocation packageFlexible hoursDay shift- ...Flexibility: OnsiteJoin a team focused on bringing innovative medical devices from concept into commercial production through strong... ...information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding...ComplaintsMedical deviceFull timeContract workFor contractors
- ...sustenance of Pharmaceutical Electrophysiology medical device products. Performs ongoing execution of... ...V&V activities) Assists in conducting Quality Assurance documentation reviews and... ...) or in investigating customer complaints as needed Supports handling complex technical...ComplaintsMedical device
$95.8k - $159.6k
...CAJoin a team focused on bringing medical technologies to market while... ...with product development, quality, clinical, and manufacturing... ...Experience working with medical devices or other regulated healthcare... ...(a) in response to a formal complaint or charge, (b) in furtherance...ComplaintsMedical deviceFull timeFor contractorsLocal area- ...Description: We are seeking an experienced Lead Quality Engineer to provide technical... ...Lead CAPA, nonconformance, deviation, complaint, and root cause investigations. Support... ...Engineering experience, preferably in medical device, pharmaceutical, biotech, or other regulated...ComplaintsMedical device
$90k - $120k
...Description Regulatory Affairs and Quality Assurance Specialist Location: Huntington Beach, CA... ...deliver safe, reliable, and innovative medical devices that improve patient outcomes.... ...risk management activities Support complaint handling, including triage, documentation...ComplaintsMedical deviceFull time- ...Quality EngineerThe Quality Engineer is responsible for maintaining quality and control... ...and post-market performance of medical devices. Responsibilities include collaborating... ...decisions, resolving and documenting customer complaint and manufacturing investigations, and representing...ComplaintsMedical deviceWorldwide
$155.9k - $259.8k
...leaders focused on optimizing production, quality, and safety in highly regulated... ...Supervisory/Leadership experience.Preferred:Medical Device experience highly preferred.Automation... ...disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an...ComplaintsMedical deviceFull timeFor contractorsWork experience placement$89.4k - $148.9k
...Flexibility: OnsiteStryker is hiring a Senior Quality Engineer for our Peripheral Vascular... ....Support manufacturing-related complaints, field actions, commercial holds, and containment... ...preferred Or relatedExperience in the medical device industry with knowledge of U.S. and...ComplaintsMedical deviceFull timeFor contractorsWork at office- ...seeking a highly experienced Principal Quality Engineer to lead quality engineering initiatives... ...investigations involving customer complaints, nonconformances, deviations, and... ...years of quality engineering experience in Medical Device, Pharmaceutical, Biotechnology,...ComplaintsMedical deviceRemote work
$118k - $196.6k
...platforms. This role bridges advanced medical device hardware with high-performance digital... ...complex R&D prototypes.Work alongside R&D, Quality, Manufacturing, Regulatory, and... ...disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation...ComplaintsMedical deviceFull timeFor contractorsWork experience placement- ...support the development of innovative medical device technologies designed to address complex... ...File records.Collaborate with Marketing, Quality, Manufacturing, Regulatory Affairs, and... ...is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation...ComplaintsMedical deviceFull timeFor contractorsWork at office
$89.4k - $148.9k
...flexibility on the hours. *Join a team focused on delivering high-quality medical devices through robust manufacturing processes and continuous... ..., unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding...ComplaintsMedical deviceFull timeFor contractorsWork at officeMonday to FridayAfternoon shift$130k - $160k
...training, podium presentations, publications, complaint management etc. Collaborate with manager... ...for the safe and effective use of the device. Create VOC, collect and analyze VOC,... ...years product management experience in medical device or related industry. Able to travel...ComplaintsMedical deviceWork at officeShift work- ...OrthAlign, Inc. , a Smart Technology, growing medical device company, has an immediate opening for a Supplier Quality Engineer responsible for managing supplier... ...Implements improvement plans for any supplier related complaints or process issues. Assist in supplier...ComplaintsMedical deviceLocal areaImmediate start
$130k - $160k
...collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world,... ...peer‑peer training, podium presentations, publications and complaint management. Collaborate with manager on annual strategic...ComplaintsMedical deviceWork at officeShift work$86.6k - $119.2k
...Bio-Rad Irvine Distribution Center requires a dedicated Quality System Specialist to provide the leadership and direction needed to support... ...combination of education and experience, relevant medical device industry and quality systems experience in a regulated distribution...Medical deviceWork at office- ...Quality Control Leadership Position This leadership position is responsible for planning... ...and correct customer issues and complaints regarding quality. Oversees direct reports... ...preferably in the investment casting, medical device, or aerospace industry. Six Sigma...ComplaintsMedical devicePermanent employmentCasual work
$124.7k - $205.8k
...is one of the largest global medical technology companies in the world... ...complex medical systems and devices. The ideal candidate will... ..., engagingappropriate R&D, quality, and vendor resources Identify... ..., marketing, and quality/complaint handling teams for post-market...ComplaintsMedical deviceHourly payShift work- ...Job Description: Customer Service Specialist Position: Customer Service Specialist... ...interventional and implantable medical devices. Our commitment to quality and innovation drives us to produce... ...in the resolution of customer complaints and escalations, ensuring timely and...ComplaintsMedical deviceWork at officeVisa sponsorship
$109k - $174.8k
...accountability of investigational devices and trial materials;... ...Global Strategic Marketing, Medical Affairs, Regulatory Affairs,... ...clinical studies to provide quality deliverables while maintaining... ...teams (Research & Development, Complaint Handling, Quality/Regulatory,...ComplaintsMedical deviceFull timeFor contractorsInterim roleLocal areaImmediate startRemote work- We are seeking a detail-oriented Complaint Handling Specialist to join our Quality Assurance team. This role supports and manages medical device complaint activities — including intake, documentation, triage, investigation, regulatory assessment, and closure — ensuring...ComplaintsMedical deviceWork at office
$60k - $70k
...driving our mission forward. As a global medical technology leader for nearly 100 years,... ...in implementing and integrating medical devices or clinical solutions into clinical practice... ...Professionals), product handling and complaints, expense reporting, sales activities and...ComplaintsMedical deviceRemote workFlexible hoursAfternoon shift$99k - $120k
...We're looking for a Sr. QA Engineer to help build quality into every stage of our medical device development and manufacturing. You'll have broad ownership... .... Conduct and document investigations of NCRs, complaints, and deviations, providing effective and sustainable...ComplaintsMedical deviceRemote work- ...Software Quality Engineer Relevant Experience(in Yrs) - B.S. in Electrical or Computer... ...working in a regulated environment (Medical Device, Aerospace, etc.). This includes knowledge... ...quality system software projects are complaint with ASP Computer System Development...ComplaintsMedical device
$163.4k - $322.1k
...engagements across supply chain, manufacturing, quality, and procurement while also shaping the... ...and procurement for biopharmaceutical, medical device, and broader life sciences... ...management, master data management, or product complaint triage and initial investigationAbility...ComplaintsMedical deviceStart working todayLocal areaFlexible hoursShift work
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