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Quality Control Inspector jobs at Abbott - 586 jobs

  • Global Quality Policy & Advocacy Leader

    Gilead Sciences, Inc. 4.5company rating

    Washington, DC jobs

    A leading biopharmaceutical company is seeking a Senior Director of Quality Policy and Advocacy to lead global policy initiatives. This role requires extensive experience in Quality strategies, particularly within North American regulatory landscapes. You will be responsible for advocating Gilead's portfolio interests and engaging with stakeholders to resolve complex Quality issues. The ideal candidate will have a strong background in regulatory affairs, leadership skills, and the ability to communicate effectively with diverse audiences. This role offers a competitive salary and benefits. #J-18808-Ljbffr
    $91k-117k yearly est. 4d ago
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  • Mammographer QC Tech

    Wellstar Health System 4.6company rating

    Roswell, GA jobs

    How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well‐being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives. Work Shift Day (United States of America) Job Summary: Must be flexible with work hours to meet department needs. Must be dependable, accountable and cooperative. Assists with providing safe, age appropriate care to the patient by performing all exams provided by the department according to department procedures. Has the knowledge and ability to properly and safely obtain a quality diagnostic study. Responsible for performing a wide variety of technical procedures requiring independent judgement, ingenuity and initiative in the utilization of the equipment for the diagnosis and/or treatment of diseases. Able to independently perform job functions. Sets up the equipment to provide imaging service and positions patient for the procedure. Must maintain minimum FDA/MQSA requirements for continuing education, experience and equipment. Able to document results of QC/QA accurately and timely on approved ACR or OEM forms. Keeps abreast of new rules and regulations set forth by ACR and/or FDA/MQSA. Must be primary QC tech at facility, performing at least of the required QC at the facility. Core Responsibilities and Essential Functions: Maintains Quality Control Program: * a. Perform daily quality control functions for Selenia and Dimensions units per FDA & ACR regulations. * b. Document daily quality control results and notify supervisor of any abnormal findings or concerns. * c. Perform monitor and phantom testing for satellite facilities read at the Kennestone location. * d. Report all repairs to Medical Imaging Biomed. * e. Report quarterly repeat rates. Maintain Quality Assurance Program: * a. Maintain all credentials for technologists, radiologists and physicist according to FDA and ACR guidelines. * b. Prepare for annual ACR & FDA inspection. * c. Prepare for ACR inspections. * d. Work with physicist to remain knowledgable of new and current regulations. * e. Gather peer review information for radiologists and system * f. Assure all physicist recommendations are corrected within 30 days. Tracking and Observation * a. Utilize current tracking system for data collecting statistics. * b. Perform mock surveys. * c. Communicate all safety concerns and participate in performance Improvement opportunities. * d. Assure all physician and patient letters are mailed out within 30 days. * e. Work closely with the Interventional nurse and tech extender for patient tracking. * f. Assist with pending work reports to assure timely interpretations. * g. Assist Radiologist with statistics. * h. Build tumor board roster in PACS. Assist in other modalities and/or locations as needed: * a. Assist other satellite facilites that need QC/QA guidance. * c. Understands pre and post procedural care. * d. Demonstrates and understands sterile technique. * e. Assist patients with education and reducing anxiety. * f. Attends departmental meetings giving updates and presentations regarding stats and PI activities. Meets Service Recovery and Customer Service Guidelines as needed: * a. Ability to work in a tracking system environment. * b. Provides privacy for patients, family members and customers. * c. Utilizes appropriate AIDET techniques. * d. Assist Outcomes Department with clinical information regarding patients. * e. Direct patients with financial concerns to the appropriate department. Performs other duties as assigned Complies with all WellStar Health System policies, standards of work, and code of conduct. Required Minimum Education: Graduate of AMA approved School of Radiology Technology Required Minimum License(s) and Certification(s): All certifications are required upon hire unless otherwise stated. ARRT‐R ‐ ARRT Radiography ARRT‐M ‐ ARRT Mammography BLS ‐ Basic Life Support or BLS‐I ‐ Basic Life Support ‐ Instructor Additional License(s) and Certification(s): Required Minimum Experience: Minimum 1 year of experience as a Mammography Tech Required and Required Minimum Skills: Competent in all aspects of Mammography, patient positioning, exposure factors and radiation protection. Must have an understanding of anatomy and pathology as to how they affect the quality of a procedure. Competent to perform all quality control / quality assurance tests based on ACR recommendations and OEM recommendations. Able to document results of QC/QA accurately and timely on approved ACR or OEM forms. Keeps abreast of new rules and regulations set forth by ACR and/or FDA/MQSA. Must exhibit excellent communication skills because this position requires frequent verbal and written communications with: physicians, patients, visitors, departmental staff and nursing staff. The employee obtains, presents and discusses clinical information regarding job responsibilities on a routine basis. Candidate must be able to explain or give directions to maintain goodwill, and obtain cooperation with all contacts. Must possess the ability to function independently and under pressure while still actively participating in a team environment. Position requires the employee to exhibit excellent customer service skills at all times. Must be able to perform effectively in a stressful and fast paced work environment. Must have the ability to prioritize appropriately. Must be detail oriented and have the capacity to effectively multitask throughout the work shift. Must have excellent communication skills and the capacity to interact professionally with a variety of customers, including but not limited to patients, families, co‐workers, volunteers, and physicians throughout the work shift. Must possess the ability to function independently, yet productively as a cooperative team member with various work teams associated with the position. Must be compliant, with a willingness to follow all Hospital policies as well as the established practices, protocols and procedures of the position, Department and applicable professional standards Competent in all aspects of Mammography, patient positioning, exposure factors and radiation protection. Must have an understanding of anatomy and pathology as to how they affect the quality of a procedure. Join us and discover the support to do more meaningful work‐and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
    $27k-38k yearly est. 1d ago
  • NDT Inspector I

    Veridiam 4.2company rating

    El Cajon, CA jobs

    Veridiam is a strategic manufacturing partner with over 60 years of experience serving the aerospace, industrial, medical, and nuclear markets. Our roots were formed in the exacting nuclear and aerospace industries, expanded into Medical where we have supplied critical components to a global customer base. We currently provide elegant solutions across a broad range of customers and diverse markets. At Veridiam we recognize that talent is at the forefront of our organization and define who we are in today's industry. POSITION SUMMARY Perform nondestructive testing (NDT) utilizing one of the NDT methods, such as ultrasonic testing (UT), radiography testing (RT), penetrant testing (PT), etc. techniques. Perform tests based on applicable methods. Perform visual and dimensional inspection. Generate inspection and test reports. ESSENTIAL DUTIES AND RESPONSIBILITIES Perform tests to inspect tubing materials, thinner welds, surface flaws, corrosion, wall sizing and thicker forms of welding that may harbor deviations from specifications. Set up equipment to perform non-destructive testing utilizing ultrasonic testing and/or eddy current testing methods on parts, following specified procedures. Examine surface and locate discontinuities in product or metal structure. Perform visual and dimensional inspection of various materials and products including welds. May develop and/or follow work instructions for approved procedures. Prepares and generates reports and/or documentation outlining findings and conclusions. Prepare and generate non-conformance reports in accordance with the Quality Management System specifications. Evaluate test and inspection results against designated standards. May participate in customer and/or quality audits. Ensures instruments and tools are maintained and calibrated according to schedule. Maintain clean and orderly work environment. Demonstrates ability to appear for work on time, follow directions from a supervisor, interact well with co-workers, understand and follow work rules and procedures, comply with company policies and procedures, goals and objectives, and accepts constructive feedback. Other duties as assigned, requested or needed. POSITION REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Education and Experience: High school diploma or General Education Development (GED). Minimum two (2) year's related metal material inspection experience or equivalent of education and experience. Prior experience and ultrasonic testing or eddy testing certifications preferred. Knowledge, Skills and Abilities: Knowledge of visual and dimensional inspection methods. Knowledge of and ability to use nondestructive testing methods including ultrasonic and eddy current testing techniques. Knowledge of geometric dimensioning and tolerancing (GD&T). Ability to understand and follow standard operating and safety procedures. Ability to prioritize and handle workflow. Read and comprehend verbal and written instructions. Ability to use basic mathematical equations. Knowledge of and ability to use basic computer functions. Ability to measure and read dimensional tolerance tools and equipment. Ability to view details in close range. The above statements are intended to describe, in broad terms, the general functions and responsibility levels and characteristics of positions assigned to this classification. They should not be viewed as an all-inclusive list of duties and responsibilities. Management has the right to change duties at any time to meet business needs. Veridiam offers competitive wage and excellent benefit package including medical, dental, vision, 401(k) (with company match) and basic life/AD&D. In addition to Paid Time Off, Holidays and career advancement opportunities. Pay Rate: The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc. Veridiam, Inc. is an Equal Employment Opportunity (EEO) employer and takes pride in a diverse environment. As an Equal Opportunity Employer, Veridiam will recruit and select applicants for "This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Applicants must be a U.S. citizen or national, U.S. lawful permanent resident, person granted asylee status in the U.S., or person admitted into the U.S. as a refugee."
    $40k-52k yearly est. 5d ago
  • Quality Control Inspector

    DEKA Research & Development 4.3company rating

    Manchester, NH jobs

    DEKA R&D has an immediate opening for a Quality Control Inspector to work in a dynamic Medical Device Research and Development company. This position is a highly visible role with significant and direct impact on the development and success of multiple engineering projects. Responsibilities as a Quality Control Inspector: Interpret Mechanical and Electrical print reading and apply inspection best practices Operate CMM equipment and utilize various measuring tools for inspection of medical device components Communicate effectively and promptly across multiple projects to provide feedback on inspection of parts Inspect various mechanical and electrical components and assemblies through incoming inspection Interpret ASME Y14.5 and GD&T standards throughout the inspection process for compliance and best practices Provide feedback on inspection activities to improve efficient whether individually or in a cross-functional setting To be successful as a Quality Control Inspector, you will need the following qualifications: 3+ years of experience in a regulated industry CMM programming, Metrology and/or CQI certified is a plus Basic GD&T knowledge required, Advanced GD&T knowledge preferred Proficient with mechanical measuring equipment such as micrometers, calipers, optical comparator Ability to operate CMMs following precise instructions Inspection of soldered components and Printed Circuit Board (PCB) assemblies; IPC-A-610 certification preferred Computer skills and knowledge; ability to learn new software (Experience with Jira is a plus) About DEKA: One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age. Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
    $43k-54k yearly est. Auto-Apply 54d ago
  • Quality Control Inspector III

    Alphatec Spine 4.4company rating

    Memphis, TN jobs

    Under Quality supervision, independently evaluates materials, components, subassemblies, and finished medical devices to ensure conformance to engineering drawings, specifications, and approved procedures. The Quality Control Inspector III serves as a technical subject-matter expert for inspection methods, drawing interpretation, GD&T, and quality system requirements. This role supports advanced inspections, nonconformance disposition activities, and provides technical guidance to lower-level inspectors. ESSENTIAL DUTIES AND RESPONSIBILITIES Perform advanced Quality Control inspections per ATEC procedures with minimal oversight Independently interpret and apply complex engineering drawings, specifications, and GD&T (Geometric Dimensioning & Tolerancing) Execute dimensional, visual, functional, and cosmetic inspections using advanced metrology equipment (Micro-Vu, vision systems, optical comparators, height gages, hand tools, etc.) Perform and review First Article Inspections (FAI), in-process inspections, and final release inspections Provide technical support and mentoring to QC Inspector I and II personnel regarding inspection techniques, acceptance criteria, and documentation requirements Identify and document nonconforming material in accordance with established procedures; support Nonconformance Record (NCR) activities as required Generate, review, and approve quality records including inspection records, nonconformance reports, deviations, scrap documentation, and rework verifications Ensure inspection records meet Good Documentation Practices (GDP), traceability, and audit readiness requirements Perform ERP (SAP) transactions required for inspection, material status changes, and product release Interface with Manufacturing, Engineering, Purchasing, Shipping/Receiving, and Supplier Quality to resolve inspection and quality issues Support root cause investigations, corrective actions, and continuous improvement initiatives related to inspection processes and product quality Assist and support internal, external, and regulatory audits as a technical inspection representative Identify opportunities to improve inspection efficiency, risk-based inspection strategies, and measurement system effectiveness Read, understand, and comply with all company policies, procedures, and quality system requirements Other duties as assigned Requirements The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Strong communication skills, both verbal and written Strong organization skills and attention to detail Intermediate math and computer skills required Firm understanding of 21 CFR (Code of Federal Regulations), Part 820, ISO 13485, Good Documentation Practices (GDP) Firm understanding of ASTM (Association of Systems & Test Methods) standards and Heat Treat conditions per ASTM standards Experience in a controlled or regulated environment required Inspection experience with Optical Comparators, Vision Systems, hand tools, and other calibrated gauges Education and/or Experience High School Diploma or equivalent 4-12 years of experience working in a manufacturing or medical device industry preferred. Familiarity with quality concepts such as visual inspection and defect identification. For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable). ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws. Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $26- $30 an hour full-time salary range. Benefits Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k, IRA) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays) Free Food & Snacks Wellness Resources Stock Option Plan
    $26-30 hourly Auto-Apply 3d ago
  • QC Incoming Inspector I, 1st Shift

    Anika Therapeutics 4.3company rating

    Bedford, MA jobs

    Summary of Primary Responsibilities: The QC Incoming Inspector completes all activities required to approve raw materials for use in product manufacture. The position also performs inspection activities during in-process manufacturing. Specific Responsibilities: Perform quality line clears and in process inspections during the inspection and packing processes according to specific SOP requirements Issue lot numbers and control labels for incoming raw materials; perform inspections per internal procedures and specifications Release approved raw materials for use in manufacturing process to include completion of associated documents, notice of approval form (bin card) and relabeling of inventory Review MPS of other incoming inspectors for approval and release. Monitor and perform annual retain inspection; coordinate required retesting with QC; complete required documentation Perform OOS investigations and participate in MRB as required for rejected materials Perform as SME for the function and provide training as required to new employees, contractors and other QA personnel Perform biennial review for designated procedures and MPS as needed Documents; author and complete DCR as required Document all work activities according to Good Documentation Practices Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Participate in other projects as assigned Job Complexity: The position works on assignments that are routine in nature and receives detailed instruction on all work. Supervisory Responsibilities: None Required Qualifications: Associates degree in the life science or relevant work experience 0 - 1 year of experience in a cGMP facility or previous experience in a QA/QC role within the industry; internship experience considered Experience using Microsoft Office or an ERP system Desired Experience, Knowledge, and Skills: Bachelor's degree preferred Experience working in a clean room environment Excellent communication and documentation skills The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.
    $41k-60k yearly est. Auto-Apply 60d+ ago
  • QC Incoming Inspector I

    Anika Therapeutics 4.3company rating

    Bedford, MA jobs

    Summary of Primary Responsibilities: The QC Incoming Inspector completes all activities required to approve raw materials for use in product manufacture. The position also performs inspection activities during in-process manufacturing. Specific Responsibilities: Perform quality line clears and in process inspections during the inspection and packing processes according to specific SOP requirements Issue lot numbers and control labels for incoming raw materials; perform inspections per internal procedures and specifications Release approved raw materials for use in manufacturing process to include completion of associated documents, notice of approval form (bin card) and relabeling of inventory Review MPS of other incoming inspectors for approval and release. Monitor and perform annual retain inspection; coordinate required retesting with QC; complete required documentation Perform OOS investigations and participate in MRB as required for rejected materials Perform as SME for the function and provide training as required to new employees, contractors and other QA personnel Perform biennial review for designated procedures and MPS as needed Documents; author and complete DCR as required Document all work activities according to Good Documentation Practices Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Participate in other projects as assigned Job Complexity: The position works on assignments that are routine in nature and receives detailed instruction on all work. Supervisory Responsibilities: None Required Qualifications: Associates degree in the life science or relevant work experience 0 - 1 year of experience in a cGMP facility or previous experience in a QA/QC role within the industry; internship experience considered Experience using Microsoft Office or an ERP system Desired Experience, Knowledge, and Skills: Bachelor's degree preferred Experience working in a clean room environment Excellent communication and documentation skills The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.
    $41k-60k yearly est. Auto-Apply 60d+ ago
  • Quality Control Inspector (2nd Shift)

    Irhythm 4.8company rating

    Orange, CA jobs

    Career-defining. Life-changing. At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career About This Role: The 2nd Shift Quality Control (QC) Inspector is responsible for supporting manufacturing operations during second shift by performing inspection, documentation review, and batch release readiness activities for finished goods and sub-assemblies. This role focuses on reviewing batch records, travelers, and routers, ensuring Good Documentation Practices (GDP) compliance, identifying quality issues, and initiating nonconformances (NCs) when required. The QC Inspector also provides Receiving Inspection (RI) support as needed to ensure material flow continuity and compliance with inspection requirements. Why This Role Is Critical Provides real-time quality oversight on second shift, ensuring batch records, travelers, and GDP compliance are verified at the time of execution rather than retrospectively. Enables timely identification and containment of nonconformances, reducing quality escapes, rework, and compliance risk. Supports on-time release readiness and uninterrupted manufacturing flow, preventing inspection and documentation backlogs into first shift. Strengthens audit readiness and cross-shift continuity, ensuring clear handoff and sustained control of quality issues across shifts. What You WIll Be Doing Batch Record, Traveler & Router Review Perform detailed review of batch records and travelers for finished goods and sub-assemblies to ensure completeness, accuracy, and compliance with approved procedures. Verify that all required manufacturing steps, inspections, testing reports, in-process checks, and approvals are properly completed and documented. Ensure material traceability, including material lots, subassemblies, equipment identification (when applicable), and inspection status. Access and reference the electronic Quality Management System (eQMS) to ensure the current, approved revisions of drawings, specifications, procedures, and work instructions are used during inspection and batch record review activities. Verify that batch records, travelers, and inspection activities are executed against the correct released document revisions, and escalate discrepancies when outdated or incorrect documents are identified Identify documentation errors, omissions, or discrepancies and ensure timely correction in accordance with GDP requirements. Finished Goods & Sub-Assembly Inspection Perform in-process, final, or verification inspections of finished goods and sub-assemblies per approved inspection plans and work instructions. Ensure inspection results are accurately recorded and aligned with acceptance criteria. Support timely review and release readiness of manufacturing lots to maintain production flow. Nonconformance Identification & Escalation Identify, document, and initiate Nonconformance (NC) records when inspection results, documentation, or material conditions do not meet requirements. Ensure nonconforming material is properly identified, labeled, and segregated to prevent unintended use. Escalate quality issues to Quality Control leadership and Manufacturing supervision as required. Good Documentation Practices (GDP) Compliance Enforce GDP standards across all reviewed records, including batch records, travelers, routers, and inspection forms. Ensure corrections, clarifications, and late entries (when applicable) are performed per approved GDP procedures. Support identification of recurring documentation issues and participate in corrective actions or retraining as needed. Receiving Inspection (RI) Support Perform Receiving Inspection (RI) activities when required, following approved sampling plans, inspection criteria, and procedures. Verify material identification, lot traceability, and acceptance status. Accurately document RI results and communicate material status to Manufacturing and Quality teams. Compliance & Audit Readiness Perform all activities in compliance with ISO 13485, and internal QMS SOPs, DOP's and work instructions. Maintain inspection areas and records in a state of audit readiness. Support internal audits and regulatory inspections by providing accurate records and inspection evidence as requested. Cross-Shift & Cross-Functional Communication Communicate inspection results, documentation issues, and open quality concerns clearly during shift handoffs. Collaborate with Manufacturing, Quality Engineering, Receiving, and first-shift QC personnel to ensure continuity of quality controls. What We Want to See High School Diploma or GED required; Associate's or Bachelor's Degree in a technical or life sciences field is preferred. Minimum of 2-5 years of experience in a medical device manufacturing, pharma, aerospace or regulated manufacturing environment, preferably in Quality Control or Inspection. Experience navigating an electronic Quality Management System (eQMS) to review and reference released drawings, specifications, SOPs, and work instructions Working knowledge of Good Documentation Practices (GDP) and controlled document execution. Experience reviewing batch records, travelers, routers, and inspection records. Ability to identify quality issues and initiate nonconformance records in accordance with established procedures. Strong attention to detail with a focus on accuracy, compliance, and data integrity. Ability to work independently on second shift with minimal supervision. Effective verbal and written communication skills. Ability to manage multiple tasks and prioritize work to support production needs. Ways to Stand Out Experience performing Receiving Inspection (RI) or FAI activities. Familiarity with sampling plans, inspection plans, and acceptance criteria. Demonstrated experience reviewing engineering drawings, including GD&T, to identify critical-to-quality (CTQ) characteristics, specification notes, and applicable inspection requirements, and applying them during inspection and batch record review Experience using enterprise resource planning (ERP) systems (e.g., QAD, SAP) to support manufacturing execution, batch review, material status, and traceability is a plus Location: Orange County Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range $21.15 - $26.44 As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at ********************* About iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all. Make iRhythm your path forward. Zio, the heart monitor that changed the game. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact *********************. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY. For more information, see *********************************************************************************** and *****************************************
    $21.2-26.4 hourly Auto-Apply 10d ago
  • Quality Control Inspector (2nd Shift)

    Irhythm Technologies 4.8company rating

    Orange, CA jobs

    Career-defining. Life-changing. At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career About This Role: The 2nd Shift Quality Control (QC) Inspector is responsible for supporting manufacturing operations during second shift by performing inspection, documentation review, and batch release readiness activities for finished goods and sub-assemblies. This role focuses on reviewing batch records, travelers, and routers, ensuring Good Documentation Practices (GDP) compliance, identifying quality issues, and initiating nonconformances (NCs) when required. The QC Inspector also provides Receiving Inspection (RI) support as needed to ensure material flow continuity and compliance with inspection requirements. Why This Role Is Critical * Provides real-time quality oversight on second shift, ensuring batch records, travelers, and GDP compliance are verified at the time of execution rather than retrospectively. * Enables timely identification and containment of nonconformances, reducing quality escapes, rework, and compliance risk. * Supports on-time release readiness and uninterrupted manufacturing flow, preventing inspection and documentation backlogs into first shift. * Strengthens audit readiness and cross-shift continuity, ensuring clear handoff and sustained control of quality issues across shifts. What You WIll Be Doing Batch Record, Traveler & Router Review * Perform detailed review of batch records and travelers for finished goods and sub-assemblies to ensure completeness, accuracy, and compliance with approved procedures. * Verify that all required manufacturing steps, inspections, testing reports, in-process checks, and approvals are properly completed and documented. * Ensure material traceability, including material lots, subassemblies, equipment identification (when applicable), and inspection status. * Access and reference the electronic Quality Management System (eQMS) to ensure the current, approved revisions of drawings, specifications, procedures, and work instructions are used during inspection and batch record review activities. * Verify that batch records, travelers, and inspection activities are executed against the correct released document revisions, and escalate discrepancies when outdated or incorrect documents are identified * Identify documentation errors, omissions, or discrepancies and ensure timely correction in accordance with GDP requirements. Finished Goods & Sub-Assembly Inspection * Perform in-process, final, or verification inspections of finished goods and sub-assemblies per approved inspection plans and work instructions. * Ensure inspection results are accurately recorded and aligned with acceptance criteria. * Support timely review and release readiness of manufacturing lots to maintain production flow. Nonconformance Identification & Escalation * Identify, document, and initiate Nonconformance (NC) records when inspection results, documentation, or material conditions do not meet requirements. * Ensure nonconforming material is properly identified, labeled, and segregated to prevent unintended use. * Escalate quality issues to Quality Control leadership and Manufacturing supervision as required. Good Documentation Practices (GDP) Compliance * Enforce GDP standards across all reviewed records, including batch records, travelers, routers, and inspection forms. * Ensure corrections, clarifications, and late entries (when applicable) are performed per approved GDP procedures. * Support identification of recurring documentation issues and participate in corrective actions or retraining as needed. Receiving Inspection (RI) Support * Perform Receiving Inspection (RI) activities when required, following approved sampling plans, inspection criteria, and procedures. * Verify material identification, lot traceability, and acceptance status. * Accurately document RI results and communicate material status to Manufacturing and Quality teams. Compliance & Audit Readiness * Perform all activities in compliance with ISO 13485, and internal QMS SOPs, DOP's and work instructions. * Maintain inspection areas and records in a state of audit readiness. * Support internal audits and regulatory inspections by providing accurate records and inspection evidence as requested. Cross-Shift & Cross-Functional Communication * Communicate inspection results, documentation issues, and open quality concerns clearly during shift handoffs. * Collaborate with Manufacturing, Quality Engineering, Receiving, and first-shift QC personnel to ensure continuity of quality controls. What We Want to See * High School Diploma or GED required; Associate's or Bachelor's Degree in a technical or life sciences field is preferred. * Minimum of 2-5 years of experience in a medical device manufacturing, pharma, aerospace or regulated manufacturing environment, preferably in Quality Control or Inspection. * Experience navigating an electronic Quality Management System (eQMS) to review and reference released drawings, specifications, SOPs, and work instructions * Working knowledge of Good Documentation Practices (GDP) and controlled document execution. * Experience reviewing batch records, travelers, routers, and inspection records. * Ability to identify quality issues and initiate nonconformance records in accordance with established procedures. * Strong attention to detail with a focus on accuracy, compliance, and data integrity. * Ability to work independently on second shift with minimal supervision. * Effective verbal and written communication skills. * Ability to manage multiple tasks and prioritize work to support production needs. Ways to Stand Out * Experience performing Receiving Inspection (RI) or FAI activities. * Familiarity with sampling plans, inspection plans, and acceptance criteria. * Demonstrated experience reviewing engineering drawings, including GD&T, to identify critical-to-quality (CTQ) characteristics, specification notes, and applicable inspection requirements, and applying them during inspection and batch record review * Experience using enterprise resource planning (ERP) systems (e.g., QAD, SAP) to support manufacturing execution, batch review, material status, and traceability is a plus Location: Orange County Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range $21.15 - $26.44 As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at ********************* About iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all. Make iRhythm your path forward. Zio, the heart monitor that changed the game. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact *********************. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY. For more information, see *********************************************************************************** and *****************************************
    $21.2-26.4 hourly Auto-Apply 12d ago
  • Quality Control Labeling Inspector

    Vivex Biologics Inc. 3.7company rating

    Miami, FL jobs

    Description: Job Purpose The QC Labeling Inspector is responsible for maintaining a high level of inventory accuracy and integrity within the Tissue Bank. Performs final product labeling and inspections, manages transport and storage of quarantine tissue, and maintains labeling supplies. Promotes Lean Behaviors across the organization (This includes Participating in Try storming, Brainstorming and Lean Related Initiatives). Promotes Usage of Problem Solving. Ensure that Labeling Operations are in Compliance with the State and Federal Regulations and AATB Standards. Duties and Responsibilities Preparation of the QC Labeling areas as specifically described in SOPs. Performs final inspection of products for proper specifications, label accuracy, and compliance with applicable regulations, standards and Vivex Biologics, Inc. quality requirements. Combines components for final products. Applies labels to final product and adds package inserts, boxes, etc. Maintains accurate inventory of post-processing, quarantine products (frozen and room temperature). Performs disposition of nonconforming products as directed. Coordinates and stages products for sterilization. Monitors freezers and responds to alarms. Supports nonconformance investigations, when applicable. Maintains knowledge of applicable regulations and standards related to storage, handling, labeling and inspections of tissue. Maintains effective communication with management when issues arise to obtain appropriate instructions to address the issues. Performs other duties as assigned by management. Requirements: Qualifications High School/Minimum of 4 Years of Relevant Experience. Associate/Minimum of 1 Years of Relevant experience. Bachelors/Minimum of 0-1 Years of Relevant experience Working Conditions Work is indoors in environmentally controlled conditions. Overtime may be required to meet production deadlines. Some on-call and weekends may be required. Physical Requirements Able to stand for extended period. Able to lift 25 lbs. without assistance. Must be able to infrequently lift, push, pull and carry boxes weighing up to 25 pounds. Walk, squat and bend over for intervals of 15-30 minutes, with or without reasonable accommodation. Direct Reports No direct reports. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time. Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training. Vivex Biologics, Inc. with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
    $32k-44k yearly est. 9d ago
  • Quality Control Labeling Inspector

    Vivex Biologics 3.7company rating

    Miami, FL jobs

    Job Purpose The QC Labeling Inspector is responsible for maintaining a high level of inventory accuracy and integrity within the Tissue Bank. Performs final product labeling and inspections, manages transport and storage of quarantine tissue, and maintains labeling supplies. Promotes Lean Behaviors across the organization (This includes Participating in Try storming, Brainstorming and Lean Related Initiatives). Promotes Usage of Problem Solving. Ensure that Labeling Operations are in Compliance with the State and Federal Regulations and AATB Standards. Duties and Responsibilities Preparation of the QC Labeling areas as specifically described in SOPs. Performs final inspection of products for proper specifications, label accuracy, and compliance with applicable regulations, standards and Vivex Biologics, Inc. quality requirements. Combines components for final products. Applies labels to final product and adds package inserts, boxes, etc. Maintains accurate inventory of post-processing, quarantine products (frozen and room temperature). Performs disposition of nonconforming products as directed. Coordinates and stages products for sterilization. Monitors freezers and responds to alarms. Supports nonconformance investigations, when applicable. Maintains knowledge of applicable regulations and standards related to storage, handling, labeling and inspections of tissue. Maintains effective communication with management when issues arise to obtain appropriate instructions to address the issues. Performs other duties as assigned by management. Requirements Qualifications High School/Minimum of 4 Years of Relevant Experience. Associate/Minimum of 1 Years of Relevant experience. Bachelors/Minimum of 0-1 Years of Relevant experience Working Conditions Work is indoors in environmentally controlled conditions. Overtime may be required to meet production deadlines. Some on-call and weekends may be required. Physical Requirements Able to stand for extended period. Able to lift 25 lbs. without assistance. Must be able to infrequently lift, push, pull and carry boxes weighing up to 25 pounds. Walk, squat and bend over for intervals of 15-30 minutes, with or without reasonable accommodation. Direct Reports No direct reports. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time. Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training. Vivex Biologics, Inc. with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
    $32k-44k yearly est. 60d+ ago
  • Quality Control Inspector

    Avalign Technologies 4.0company rating

    Warsaw, IN jobs

    Job Description The Quality Control Inspector is responsible for inspecting received material, work-in-process, and finished products to ensure conformance with customer, work order and print specifications for our facility in Warsaw, IN on either a 2nd shift schedule. What You'll Do: Perform visual inspections using function gages and visual overlays to determine compliance of in-process and finished products to customer and work order specifications using drawings, job routers, and visual standards for acceptance. Complete inspection records, checklists, and other work order documents, as applicable. Identify and segregate non-conforming products and generate nonconforming reports when required. Accurately fill out Shop Traveler, inspection sheets and any other related documentation. Enter dimensional data into Datamyte Quality Reporting Software during inspections when necessary. Utilize measurement equipment such as Micro-Vu, Keyence, comparators, micrometers, calipers to perform inspections. Verify paperwork is complete and accurate throughout the job processes. Comply with all Company policies and procedures. Other duties as assigned. What You'll Need: Minimum of a High School Diploma or equivalent Basic math skills are needed to add, subtract, multiply and divide. Ability to read and understand product and manufacturing prints. Able to lift to 50 lbs. Able to utilize standard measurement equipment, Micro-Vu, Keyence, comparators, micrometers, calipers. Good interpersonal and communication skills. Previous inspection experience preferred. Previous experience with inspection on programmable vision systems preferred. Ability to work independently with little direct supervision. To perform this job successfully, an individual should have knowledge of Epicor, Microsoft Excel, Word, and Outlook. What You Won't Do: Feel stuck - we offer great opportunities to advance and learn Get bored - we make a high variety of products, so no day is the same Feel like a number - we're a close-knit bunch and always have each other's backs Who You Are: A self-starter who thrives in a fast-paced environment A quick learner who is always ready to gain depth of knowledge in manufacturing processes A reliable individual who knows the importance of showing up when it counts Someone who accept assignments with an open, cooperative, positive and team-oriented approach Someone who is able to plan and execute plans across teams An effective communicator, both written and verbal What You'll Enjoy: Competitive compensation and benefits package Comprehensive medical, dental, and vision insurance Paid vacation and 10 observed paid holidays per year Employer funded Basic Life and AD&D insurance Employer funded STD and LTD insurance Tuition reimbursement Great 401(k) with company match Generous employee referral bonus program Working for a thriving, performance-based company that values promoting from within and career advancement Temperature controlled environment Community involvement investing and giving back to the community Additional free resources such as travel assistance, EAP, etc. You should be proficient in: GD&T Quality Inspection Experience Quality Control Experience Machines & technologies you'll use: Measurement Gauges Calipers and Micrometers
    $32k-41k yearly est. 14d ago
  • Quality Control Inspector - 2nd shift

    Avalign Technologies 4.0company rating

    Warsaw, IN jobs

    The Quality Inspector is responsible for inspecting received material, work-in-process, and finished products to ensure conformance with customer, work order and print specifications. will be located at our facility in Warsaw, IN and assigned to a 2nd shift schedule. What You'll Do: Perform visual inspections using function gages and visual overlays to determine compliance of in-process and finished products to customer and work order specifications using drawings, job routers, and visual standards for acceptance. Complete inspection records, checklists, and other work order documents, as applicable. Identify and segregate non-conforming products and generate nonconforming reports when required. Accurately fill out Shop Traveler, inspection sheets and any other related documentation. Enter dimensional data into Datamyte Quality Reporting Software during inspections when necessary. Utilize measurement equipment such as Micro-Vu, Keyence, comparators, micrometers, calipers to perform inspections. Verify paperwork is complete and accurate throughout the job processes. Comply with all Company policies and procedures. Other duties as assigned. What You'll Need: Minimum of a High School Diploma or equivalent Basic math skills are needed to add, subtract, multiply and divide. Ability to read and understand product and manufacturing prints. Able to lift to 50 lbs. Able to utilize standard measurement equipment, Micro-Vu, Keyence, comparators, micrometers, calipers. Good interpersonal and communication skills. Previous inspection experience preferred. Previous experience with inspection on programmable vision systems preferred. Ability to work independently with little direct supervision. To perform this job successfully, an individual should have knowledge of Epicor, Microsoft Excel, Word, and Outlook.
    $32k-41k yearly est. 5d ago
  • QC Inspector

    The Sunrider Corporation 4.2company rating

    Midlothian, TX jobs

    Oversees logs and procedures and ensures Q.C. and Production are abiding by GMP and GLP company rules set forth by company SOPs. Ensuring things are made right in the first place is the best way of preventing out of specification products. ESSENTIAL DUTIES AND RESPONSIBILITIES: Includes the following, but other duties may be assigned as the company's needs dictate. Reviews and approves the Production filling batch records. Checks and audits the documents for accuracy and GMP compliance during and at the completion of filling. Checks and confirms that the correct components and compounding batch have been set-up and are being used on the appropriate packaging line. Reviews the data reported by the mechanics, machine operators, and line leads to ensure that the information is correct and entered appropriately. Responsible for placing compounded batches and finished goods that do not conform to company specifications into Quarantine status with applicable labeling. Reports any quality issues to Quality management and participates in investigations, as necessary. Performs daily housekeeping audits of the Production area logbooks and reports results to Quality management. Supports GMP training of employees. Participates in Quality System audits as directed by Quality management. Complies with Health, Safety, and Environmental responsibilities for the position. Inspects the production lines to ensure that both Production and Quality control personnel are following the required SOP to perform their jobs. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: High school diploma or GED (general education degree) and some college (science-based courses preferred). Minimum 6-months of hands-on experience as Quality audit/inspector in cGMP environment; preferably in pharmaceutical, biomedical, or medical device field (regulated industry). Experience with batch record keeping, CAPA initiation, and deviation investigation. Should have experience working on the floor of a manufacturing facility. LANGUAGE SKILLS: Fluent in reading, writing, and speaking the English language, as well as having experience with technical writing (knowing Spanish is a plus). Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from departmental manager/supervisor or other employees. MATHEMATICAL SKILLS: Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. COMPUTER SKILLS: To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software. REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit, use hands to finger, handle or feel; and reach with hands and arms. The employee is occasionally required to stand, walk, talk or hear, and taste and smell. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles (herbal powders). The noise level in the work environment is usually quiet. Sunrider Manufacturing provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
    $31k-40k yearly est. Auto-Apply 30d ago
  • QC Inspector

    The Sunrider Corporation 4.2company rating

    Midlothian, TX jobs

    Oversees logs and procedures and ensures Q.C. and Production are abiding by GMP and GLP company rules set forth by company SOPs. Ensuring things are made right in the first place is the best way of preventing out of specification products. ESSENTIAL DUTIES AND RESPONSIBILITIES: Includes the following, but other duties may be assigned as the company's needs dictate. Reviews and approves the Production filling batch records. Checks and audits the documents for accuracy and GMP compliance during and at the completion of filling. Checks and confirms that the correct components and compounding batch have been set-up and are being used on the appropriate packaging line. Reviews the data reported by the mechanics, machine operators, and line leads to ensure that the information is correct and entered appropriately. Responsible for placing compounded batches and finished goods that do not conform to company specifications into Quarantine status with applicable labeling. Reports any quality issues to Quality management and participates in investigations, as necessary. Performs daily housekeeping audits of the Production area logbooks and reports results to Quality management. Supports GMP training of employees. Participates in Quality System audits as directed by Quality management. Complies with Health, Safety, and Environmental responsibilities for the position. Inspects the production lines to ensure that both Production and Quality control personnel are following the required SOP to perform their jobs. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: High school diploma or GED (general education degree) and some college (science-based courses preferred). Minimum 6-months of hands-on experience as Quality audit/inspector in cGMP environment; preferably in pharmaceutical, biomedical, or medical device field (regulated industry). Experience with batch record keeping, CAPA initiation, and deviation investigation. Should have experience working on the floor of a manufacturing facility. LANGUAGE SKILLS: Fluent in reading, writing, and speaking the English language, as well as having experience with technical writing (knowing Spanish is a plus). Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from departmental manager/supervisor or other employees. MATHEMATICAL SKILLS: Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. COMPUTER SKILLS: To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software. REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit, use hands to finger, handle or feel; and reach with hands and arms. The employee is occasionally required to stand, walk, talk or hear, and taste and smell. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles (herbal powders). The noise level in the work environment is usually quiet. Sunrider Manufacturing provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
    $31k-40k yearly est. Auto-Apply 28d ago
  • Quality Control Inspector III

    Atec Spine 4.4company rating

    Memphis, TN jobs

    Under Quality supervision, independently evaluates materials, components, subassemblies, and finished medical devices to ensure conformance to engineering drawings, specifications, and approved procedures. The Quality Control Inspector III serves as a technical subject-matter expert for inspection methods, drawing interpretation, GD&T, and quality system requirements. This role supports advanced inspections, nonconformance disposition activities, and provides technical guidance to lower-level inspectors. ESSENTIAL DUTIES AND RESPONSIBILITIES * Perform advanced Quality Control inspections per ATEC procedures with minimal oversight * Independently interpret and apply complex engineering drawings, specifications, and GD&T (Geometric Dimensioning & Tolerancing) * Execute dimensional, visual, functional, and cosmetic inspections using advanced metrology equipment (Micro-Vu, vision systems, optical comparators, height gages, hand tools, etc.) * Perform and review First Article Inspections (FAI), in-process inspections, and final release inspections * Provide technical support and mentoring to QC Inspector I and II personnel regarding inspection techniques, acceptance criteria, and documentation requirements * Identify and document nonconforming material in accordance with established procedures; support Nonconformance Record (NCR) activities as required * Generate, review, and approve quality records including inspection records, nonconformance reports, deviations, scrap documentation, and rework verifications * Ensure inspection records meet Good Documentation Practices (GDP), traceability, and audit readiness requirements * Perform ERP (SAP) transactions required for inspection, material status changes, and product release Interface with Manufacturing, Engineering, Purchasing, Shipping/Receiving, and Supplier Quality to resolve inspection and quality issues * Support root cause investigations, corrective actions, and continuous improvement initiatives related to inspection processes and product quality * Assist and support internal, external, and regulatory audits as a technical inspection representative * Identify opportunities to improve inspection efficiency, risk-based inspection strategies, and measurement system effectiveness * Read, understand, and comply with all company policies, procedures, and quality system requirements * Other duties as assigned
    $32k-39k yearly est. 4d ago
  • Quality Control Inspector - 2nd Shift

    Avalign Technologies 4.0company rating

    Mentor, OH jobs

    The Quality Inspector evaluates statistical data to determine and maintain quality and reliability of products on a 2nd shift schedule. What You'll Do: Perform first article inspection which include detailed documentation using customer's forms. Work with minimal supervision using detailed procedures forms and manuals as a guide to job performance. In process auditing that will require the review of operator and process performance working to specifications as referred to in material routings. Use control plans, Material routing instructions, computer print outs, and Pareto charts. Interprets engineering drawings, schematic diagrams, or formulas and confers with management or engineering staff to determine quality and reliability standards. Tests products for variety of qualities such as dimensions, performance, and mechanical, electrical, or chemical characteristics Records test data, applying statistical quality control procedures. What You'll Need: High school diploma or general education degree (GED) and 5 years related experience and/or training; or equivalent combination of education and experience.
    $32k-42k yearly est. 15d ago
  • Quality Control Inspector - 1st shift

    Avalign Technologies 4.0company rating

    Greenwood, IN jobs

    The Quality Inspector evaluates statistical data to determine and maintain quality and reliability of products for our Greenwood, IN facility on a 1st shift schedule. What You'll Do: Perform first article inspection which includes detailed documentation using customer's forms. Work with minimal supervision using detailed procedures, forms and manuals as a guide to job performance. In process auditing that will require the review of operator and process performance working to specifications as referred to in material routings. Use control plans, Material routing instructions, computer print outs, and Pareto charts. Interprets engineering drawings, schematic diagrams, or formulas and confers with management or engineering staff to determine quality and reliability standards. Tests products for variety of qualities such as dimensions, performance, and mechanical, electrical, or chemical characteristics Records test data, applying statistical quality control procedures. Other duties and responsibilities may be assigned as needed. What You'll Need: High school diploma or general education degree (GED) and 5 years related experience and/or training; or equivalent combination of education and experience. Ability to read and interpret complex blueprints and drawings. Ability to perform basic math. Have ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. The Quality Inspector evaluates statistical data to determine and maintain quality and reliability of products.
    $31k-39k yearly est. 15d ago
  • Inspection & Packaging Lead (3rd shift)

    Leiters Health 3.9company rating

    Englewood, CO jobs

    Job Description Inspection & Packaging Lead (3rd shift) This position reports directly to the Inspection and Packaging Supervisors as well as the VILP Manager. The role is responsible for general support of the Visual Inspection, Labeling, and Packaging of finished sterile compounds. The Lead is responsible for ensuring the accuracy for label reconciliation, document completeness and correctness of all product identification. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positivelyimpactpatients' lives. Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. Cutting-EdgeTechnology: Work withstate-of-the-artfacilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions: Lead and perform the line/area clearance of the visual inspection or label, and packaging activities. Review of batch record during and end of visual inspection, label, and packaging activities. Assist Inspection & Packaging Supervisors in overseeing employees who are responsible for visual inspection/labeling/packaging of finished goods. Collaborate with Inspection & Packaging Supervisors to ensure timely visual inspection and labeling of products to meet scheduled batch release dates. Ensure that training on SOPs and processes remains current. Analyze Production efficiencies downtime and waste. Lead teams to improve the results. Write investigations and CAPA actions for non-conformances in the department. Work with QA to quickly resolve any variance or document errors so that product may be released on time. Lead Problem Solving activities. Assist with maintaining batch and label inventory and managing daily staffing for visual inspection and labeling. Other duties as assigned. Supervisory Responsibilities: Lead a team of Associates, providing direction, support, and training. Provide a positive and collaborative work environment through effective communication and accountability, escalating conflict promptly and fairly. Experience and Necessary Skills: 1-year previous leadership experience or comparable experience preferred. Minimum 1 years' experience in aseptic processing preferred. Knowledge of cGMP guidelines/standards. Bachelor's degree or relevant experience preferred. Demonstrated written and oral communications skills including strong presentation skills. Excellent organizational skills and results oriented. Strong results orientation. Strong Microsoft Office skills are essential, proficient in the use of spreadsheets and word processing programs Ability to effectively bring others together and reconcile differences. Able to lift up to 50 lbs. and stand for extended periods when required Must pass an eye exam confirming 20/20 near vision corrected (with contacts or glasses) or uncorrected Must pass an eye exam confirming the ability to accurately perceive color Benefits: Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) Flexible Spending & Health Savings Accounts (FSA & HSA) available Dental & Vision insurance Employer Paid Life Insurance & Employee Assistance Program Short Term & Long-Term Disability Insurance Up to 4% 401K Matching (100% vested on day one!) Generous Paid Time Off Options - vacation,sick, paid leave and holidays! $5,250 Annual Tuition Reimbursement after 6 months $1,000 Referral Bonus Program with no limit Eligible for annual bonus program Timeline: We will be accepting applications on an ongoing basis until position is filled. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter. Monday - Friday 1130pm to 8am
    $38k-52k yearly est. 13d ago
  • Inspection & Packaging Lead (3rd shift)

    Leiters Inc. 3.9company rating

    Englewood, CO jobs

    Inspection & Packaging Lead (3rd shift) This position reports directly to the Inspection and Packaging Supervisors as well as the VILP Manager. The role is responsible for general support of the Visual Inspection, Labeling, and Packaging of finished sterile compounds. The Lead is responsible for ensuring the accuracy for label reconciliation, document completeness and correctness of all product identification. Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement. Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positivelyimpactpatients' lives. Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry. Cutting-EdgeTechnology: Work withstate-of-the-artfacilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing. Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration. Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions: Lead and perform the line/area clearance of the visual inspection or label, and packaging activities. Review of batch record during and end of visual inspection, label, and packaging activities. Assist Inspection & Packaging Supervisors in overseeing employees who are responsible for visual inspection/labeling/packaging of finished goods. Collaborate with Inspection & Packaging Supervisors to ensure timely visual inspection and labeling of products to meet scheduled batch release dates. Ensure that training on SOPs and processes remains current. Analyze Production efficiencies downtime and waste. Lead teams to improve the results. Write investigations and CAPA actions for non-conformances in the department. Work with QA to quickly resolve any variance or document errors so that product may be released on time. Lead Problem Solving activities. Assist with maintaining batch and label inventory and managing daily staffing for visual inspection and labeling. Other duties as assigned. Supervisory Responsibilities: Lead a team of Associates, providing direction, support, and training. Provide a positive and collaborative work environment through effective communication and accountability, escalating conflict promptly and fairly. Experience and Necessary Skills: 1-year previous leadership experience or comparable experience preferred. Minimum 1 years' experience in aseptic processing preferred. Knowledge of cGMP guidelines/standards. Bachelor's degree or relevant experience preferred. Demonstrated written and oral communications skills including strong presentation skills. Excellent organizational skills and results oriented. Strong results orientation. Strong Microsoft Office skills are essential, proficient in the use of spreadsheets and word processing programs Ability to effectively bring others together and reconcile differences. Able to lift up to 50 lbs. and stand for extended periods when required Must pass an eye exam confirming 20/20 near vision corrected (with contacts or glasses) or uncorrected Must pass an eye exam confirming the ability to accurately perceive color Benefits: Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) Flexible Spending & Health Savings Accounts (FSA & HSA) available Dental & Vision insurance Employer Paid Life Insurance & Employee Assistance Program Short Term & Long-Term Disability Insurance Up to 4% 401K Matching (100% vested on day one!) Generous Paid Time Off Options - vacation,sick, paid leave and holidays! $5,250 Annual Tuition Reimbursement after 6 months $1,000 Referral Bonus Program with no limit Eligible for annual bonus program Timeline: We will be accepting applications on an ongoing basis until position is filled. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter. Monday - Friday 1130pm to 8am
    $38k-52k yearly est. Auto-Apply 38d ago

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