Quality Control Internship jobs at Bay Area Community Resources - 73 jobs

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. SUMMARY: The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the Environmental Monitoring (EM) Data Trending and reporting at BioMarin, while gaining an insight into the pharmaceutical/biotech industry. Over the course of 10 - 12 weeks our interns gain industry experience while working alongside our talented team on meaningful projects. The Quality Control Microbiology team is accountable for all Environmental Monitoring Data collection (sampling, plates examination and report results) of pharmaceutical manufacturing facilities as well as trending of generated data for the Novato site. The team also performs testing of raw materials, in-process materials and formulated drug substances. Additional non-routine tests include qualification of quality control media, testing of biological indicators, testing of cleaning validation and verifications samples, laboratory equipment qualification. We operate two data systems: MODA for environmental monitoring and LIMS for samples associated with processes JOB DESCRIPTION/PROJECT: * This role provides the opportunity to gain insight into the Environmental Monitoring Trending aspect of GMP manufacturing. Areas of involvement include the following: * Exploring the use of advanced tools like artificial intelligence to transform trending processes * Design appropriate AI agent to allow for the consistency and efficiency in EM Trend Reports generation * Partner with cross-functional teams and create to qualify AI agent to deliver consistent results * Interpret 21CFR, USP, EP, JP and ICH regulatory guidelines and directives Required Skills: * Proficient computer skills and working knowledge of Microsoft Office (Word, Excel, Powerpoint, Outlook) * Understanding and ability to work with various AI platforms and build AI agents * Understands Machine Learning, Generative AI, Open, AI * Excellent interpersonal, written, and verbal communication skills * Strong organizational skills with ability to prioritize and manage tasks * Ability to work independently and collaboratively Desired Skills: * Competency with statistical analysis tools such as Excel, Power BI, as well as artificial intelligence tools a plus * Interest in pursuing a career in the pharmaceutical/biotech industry * Effective project management skills are a plus Qualifications/Eligibility: * Student pursuing a Bachelor's degree in a scientific discipline or related field * Must be available to work full-time, 40 hours a week. * Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program. * Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles. Benefits of a BioMarin Internship: * Paid hourly wage, paid company holidays, and sick time * Apply skills and knowledge learned in the classroom to on-the-job experiences * Comprehensive, value-added project(s) * Develop skills specific to your major. * Opportunities for professional development by building relationships and learning about other parts of the business. * Participate in company all hands meetings, monthly community lunches * Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks * Access to Employee Resource Groups Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S., the salary range for this position is $24 to $27 per hour, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

PAY $25 to $33 per hour Reporting to the Quality Assurance Manager, the Quality Compliance Associate is responsible for assisting with all cGMP documentation. This includes the review and editing of controlled documents, change control processing, and cGMP document compliance. Ensure documents and SOP's are setup correctly to ensure compliance to State, Federal, and International regulating bodies. Duties and responsibilities include assisting site QA cGMP compliance activities. Other duties and responsibilities as assigned by the Quality Assurance Manager. ESSENTIAL FUNCTIONS Reasonable Accommodations Statement To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Essential Functions Statement(s) Assist the development, interpretation, and enforcement of Quality Systems as per corporate policy and GMP regulations under 21 CFR Part 111 and 21 CFR Part 101. Ensure proper training for QA Personnel on these GMP regulations. Provide QA support to manufacturing to ensure that requirements and specifications are met while interfacing with manufacturing partners to ensure we are testing appropriately. Provide QA support of Research and Development during new product launches and establishes key checkpoints for new products and processes. Review and edit Standard Operating Procedures (SOPs), Work Instructions, and forms to improve Quality Systems documentation that meets quality objectives. Assist with internal audits to existing company Quality Systems procedures and ensure all findings are addressed appropriately per cGMP regulations and for continued improvement to the company Quality System. Assist in FDA, CDPH, and third-party audits to meet 21 CFR Part 111. Ensure all findings are addressed appropriately to ensure continued certification and compliance to Federal and State regulations. Manage supplier qualification including current approve supplier list, associated supplier qualification activities such as establishment, documentation and auditing. Other duties as assigned. POSITION QUALIFICATIONS Competency Statement(s) Leadership - Ability to influence others to perform their jobs effectively and to be responsible for making decisions. Positive - Ability to view all situations with a positive attitude. Innovative - Ability to look beyond the standard solutions. Communication - Ability to communicate effectively with others using spoken and written word clearly and concisely. Detail Oriented - Ability to pay attention to the minute details of a project or task. Negotiation Skills - Ability to reach outcomes that gain the support and acceptance of all parties. Strategic Planning - Ability to develop a vision for the future and create a culture in which the long range goals can be achieved. SKILLS & ABILITIES Specific & Required Responsibilities/Skills: Ensure all quality documents adhere to applicable laws and standards Assist with document control process and chance control process Perform cGMP internal audits of procedure, processes and documentation to ensure compliance. Ensure warehouse and facility compliance to NSF and FDA standards for cGMP practices. Keep training documentation for the site. Assist in external audits for potential co-manufacturer assessments Must have a systematic problem-solving approach Able to travel for up to 10% time is required. Review and revise SOPs and specification to ensure compliance Assist with product review and/or release as needed. Must have excellent verbal, written and interpersonal communication skills. Knowledge, Experience and Skills Demonstrates in-depth knowledge of GMPs. Strong working knowledge of cGMPs (US, Canada, and International). Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements. Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is a plus. Focus on compliance while being able to minimize or reduce testing costs at all times Computer Skills Must be proficient with MS Office/Gsuite and have advanced Excel skills. Familiarity with Smartsheet and Monday.com project management tools Familiarity with SAP is preferred. Other Requirements High school diploma or equivalent, BA/BS Biology, Chemistry or equivalent combination of education preferred. Certificates in HACCP, PQCI or auditing a plus. 1-2 years of experience in related field within the food or dietary supplement industry. Work located at HQ in Watsonville, attendance mandatory on a daily basis.

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. We are seeking an individual to join our Quality Compliance department. This role conducts internal and external audits to ensure our biopharma operations comply with applicable regulations, standards, and company procedures. The ideal candidate brings hands-on GMP/GxP auditing experience within the life sciences industry and partners cross-functionally to drive continuous improvement and a strong culture of compliance.Responsibilities Internal Audits: Plan, conduct, and report risk-based GxP audits across manufacturing, QC, labs, validation, and supply chain. Supplier Audits: Lead and support vendor audits and monitor ongoing supplier performance, as needed. Audit Execution: Develop audit agendas, checklists, and sampling strategies aligned with regulatory expectations. Reporting & CAPA: Issue clear audit reports, classify findings, and track CAPA effectiveness to closure. Inspection Readiness: Support regulatory inspection readiness. Gap Assessments: Assess compliance against regulations and industry standards and recommend improvements. Cross-Functional Partnership: Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems. Metrics & Communication: Maintain audit schedules, dashboards, and communicate status and trends to management. Quality Improvement: Support SOP development, training, and continuous improvement initiatives. Additional Support: Willing to support activities related to post-marketing safety and surveillance and additional responsibilities as needed. Minimum Qualifications Education: Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience. Experience: 2-5 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry, including audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control). Regulatory Knowledge: Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GxP principles. Communication: Strong writing skills and attention to detail; able to produce clear, evidence-based audit reports. Technical Proficiency: Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification. Stakeholder Management: Excellent communication and stakeholder management skills; comfortable engaging at all levels. Preferred Qualifications Certification: Certified Quality Auditor (CQA) - ASQ, or equivalent certification; candidates without certification must demonstrate the ability and willingness to obtain it within a defined timeframe. Vendor Oversight: Experience auditing CMOs/CDMOs and complex supply chains. Digital/Data: Background with data integrity, CSV, Annex 11, and Part 11 assessments. Specialized Manufacturing: Exposure to biologics, cell & gene therapy, aseptic processing, or sterile manufacturing. Post-Marketing: Knowledge of ISO 9001/13485 and quality systems related to post-marketing safety and surveillance (as applicable). Core Competencies Integrity & objectivity in evidence gathering and reporting. Risk-based thinking and prioritization. Analytical problem-solving and pragmatic recommendations. Collaboration across functions and suppliers. Time management, organization, and follow-through. Work Conditions On site based in San Diego. Occasional travel for supplier audits. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Quality Systems Associate will support and maintain Capricor's Quality Management System (QMS) to ensure compliance with FDA, GMP, ISO 9001, and internal quality standards. This role will assist in document control, training, audit preparation, quality records management, and system administration while collaborating across functional teams to strengthen Capricor's quality operations.This is an excellent opportunity for someone who is detail‑oriented, organized, and eager to grow their quality career in a fast‑paced biotech environment.Responsibilities Support maintenance and continuous improvement of the Quality Management System (QMS) according to FDA, GMP, and ISO 9001 requirements. Assist in document control activities, including creation, revision, routing, issuance, and archival of controlled documents. Help manage and track corrective and preventive actions (CAPA) to ensure timely investigation, follow‑up, and closure. Assist in preparing for and conducting internal audits; support readiness for external audits and inspections. Coordinate and track employee training activities to ensure staff remain compliant and current with required qualifications. Support management of deviations, non‑conformances, and audit findings, ensuring documentation is accurate and complete. Assist with implementing and maintaining change control processes, ensuring proper documentation, review, and approval. Collaborate with cross‑functional teams (QA, QC, Manufacturing, Facilities, R&D) to support quality system activities and improvements. Help generate, analyze, and maintain quality metrics and trend reports to support continuous improvement. Assist with administration of quality system software, including user access management, record maintenance, and troubleshooting. Stay informed on evolving regulations, guidance documents, and industry best practices. Required Skills Bachelor's degree in Life Sciences, Engineering, or a related field. Minimum 2+ years of experience in quality systems, quality assurance, or quality operations within a regulated industry (pharmaceuticals, biologics, medical devices, etc.). Knowledge of FDA regulations, GMP guidelines, and ISO 9001 standards. Strong attention to detail and organizational skills. Ability to work independently and collaboratively in a fast‑paced environment. Proficiency in Microsoft Office (Word, Excel, PowerPoint). Experience with QMS or electronic quality system software platforms. Strong written and verbal communication skills for effective cross‑functional collaboration. Preferred / Nice-to-Have Skills Experience supporting audits, CAPA processes, deviations, or change control. Familiarity with electronic document management systems (EDMS) or commercial QMS tools. Experience in a GMP manufacturing, biologics, or cell therapy environment. Exposure to ISO audit practices or participation in internal audits. Ability to analyze quality data, produce reports, and identify trends. Work Environment / Physical Demands Primarily office‑based, focusing on quality system management and documentation activities. Requires prolonged periods of computer use for documentation, reporting, and system administration. Occasional lifting of office materials up to 15 pounds. Ability to move between office and operational areas to support audits and cross‑functional work. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Supplier Quality Associate is a critical role responsible for overseeing the development and maintenance of a robust supplier quality program, managing external audit programs, and ensuring compliance with Good Manufacturing Practice (GMP) standards. This position will drive supplier qualifications, conduct risk-based audits, and collaborate with cross-functional teams to maintain high-quality standards and support continuous improvement. The ideal candidate is a detail-oriented professional with extensive experience in supplier quality management and GMP/GLP environments, capable of working independently to meet project goals while ensuring regulatory compliance. This role will play a pivotal part in upholding Capricor's commitment to quality and excellence in the development of innovative therapies.The team this person will be joining develops and maintains the Supplier Quality Program, conducts supplier qualifications and audits, manages SCAR activities, generates and manages Quality Agreements, and develops SOPs.Responsibilities Develop and Maintain Supplier Quality Program: Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain. Travel: Occasional travel may be required for supplier audits or vendor meetings. Create Supplier Scorecards: Develop and maintain scorecards to evaluate supplier performance and drive accountability. Ensure Audit Readiness: Maintain audit readiness and compliance with GMP and other regulatory standards. Conduct Supplier Qualifications and Audits: Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality. Manage SCAR Activities: Oversee all supplier corrective action request (SCAR) processes, ensuring timely resolution of issues. Collaborate on Material Specifications: Work with cross-departmental teams to develop and refine material specifications. Prepare Quality Metrics: Compile and present quality metrics to stakeholders to support decision-making. Address Quality Issues: Partner with internal teams to resolve supplier quality and audit-related challenges. Drive Best Practices: Contribute to the development and implementation of best practices to enhance compliance and performance. Perform Data Analysis: Conduct data analysis and maintain organized records, reports, and databases to support quality processes. Implement Continuous Improvement: Recommend and implement measures to enhance quality processes and operational efficiency. Present Data Internally: Deliver data-driven insights to support decision-making and quality initiatives. Work Independently: Operate with minimal supervision to achieve project goals and meet deadlines. Review and Approve Documents: Review and approve assigned documents to ensure accuracy and compliance. Perform Additional Duties: Undertake other quality-related responsibilities as assigned to support organizational objectives. Requirements Education: Bachelor's degree in a relevant Biological Science discipline required. Experience: 3 years of experience in a GMP Quality Control laboratory or GMP/GLP setting required, with direct experience in Supplier Quality Management and corporate/supplier audits. Experience conducting audits is a plus. Supplier/Vendor Qualification: 3+ years of hands-on experience in qualifying suppliers and vendors, including risk assessments, capability evaluations, and ongoing performance monitoring. SCAR Management: Experience managing Supplier Corrective Action Requests (SCARs), from initiation through closure, ensuring timely and effective resolution of quality issues. SOP Development: Skilled in drafting, revising, and maintaining SOPs to support quality system effectiveness and regulatory compliance. Experience facilitating Supplier Quality Agreements is a plus. Technical Skills: Proficiency in Outlook, MS Office, and eQMS is a plus Communication and Teamwork: Excellent communication, time-management, and teamwork skills to collaborate effectively across departments. Organizational Skills: Strong organizational skills and attention to detail to manage records, reports, and databases. Multitasking: Ability to prioritize and manage multiple responsibilities in a fast-paced environment. Work Environment Adaptability: Ability to gown and work in classified areas for audits or inspections. Independent Work: Ability to independently perform tasks, generate reports, and escalate issues as needed. ASQ CQA certification preferred; candidates without current certification must demonstrate a willingness and ability to obtain certification within a specified timeframe. Strong team player with the ability to collaborate effectively across cross-functional departments. Work Environment and Physical Demands Setting: Primarily office- and laboratory-based, focusing on supplier quality management, audits, and documentation, in an office or hybrid arrangement due to limited office space. Physical Requirements: Requires gowning and working in classified areas; involves prolonged periods of computer use for data analysis, report generation, and SOP development; occasional lifting of office materials or equipment up to 20 pounds. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting AgenciesCapricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. We are seeking an individual to join our Quality Compliance department. This role conducts internal and external audits to ensure our biopharma operations comply with applicable regulations, standards, and company procedures. The ideal candidate brings hands-on GMP/GxP auditing experience within the life sciences industry and partners cross-functionally to drive continuous improvement and a strong culture of compliance.Responsibilities Internal Audits: Plan, conduct, and report risk-based GxP audits across manufacturing, QC, labs, validation, and supply chain. Supplier Audits: Lead and support vendor audits and monitor ongoing supplier performance, as needed. Audit Execution: Develop audit agendas, checklists, and sampling strategies aligned with regulatory expectations. Reporting & CAPA: Issue clear audit reports, classify findings, and track CAPA effectiveness to closure. Inspection Readiness: Support regulatory inspection readiness. Gap Assessments: Assess compliance against regulations and industry standards and recommend improvements. Cross-Functional Partnership: Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems. Metrics & Communication: Maintain audit schedules, dashboards, and communicate status and trends to management. Quality Improvement: Support SOP development, training, and continuous improvement initiatives. Additional Support: Willing to support activities related to post-marketing safety and surveillance and additional responsibilities as needed. Minimum Qualifications Education: Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience. Experience: 2-5 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry, including audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control). Regulatory Knowledge: Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GxP principles. Communication: Strong writing skills and attention to detail; able to produce clear, evidence-based audit reports. Technical Proficiency: Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification. Stakeholder Management: Excellent communication and stakeholder management skills; comfortable engaging at all levels. Preferred Qualifications Certification: Certified Quality Auditor (CQA) - ASQ, or equivalent certification; candidates without certification must demonstrate the ability and willingness to obtain it within a defined timeframe. Vendor Oversight: Experience auditing CMOs/CDMOs and complex supply chains. Digital/Data: Background with data integrity, CSV, Annex 11, and Part 11 assessments. Specialized Manufacturing: Exposure to biologics, cell & gene therapy, aseptic processing, or sterile manufacturing. Post-Marketing: Knowledge of ISO 9001/13485 and quality systems related to post-marketing safety and surveillance (as applicable). Core Competencies Integrity & objectivity in evidence gathering and reporting. Risk-based thinking and prioritization. Analytical problem-solving and pragmatic recommendations. Collaboration across functions and suppliers. Time management, organization, and follow-through. Work Conditions On site based in San Diego. Occasional travel for supplier audits. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Quality Systems Associate will support and maintain Capricor's Quality Management System (QMS) to ensure compliance with FDA, GMP, ISO 9001, and internal quality standards. This role will assist in document control, training, audit preparation, quality records management, and system administration while collaborating across functional teams to strengthen Capricor's quality operations.This is an excellent opportunity for someone who is detail‑oriented, organized, and eager to grow their quality career in a fast‑paced biotech environment.Responsibilities Support maintenance and continuous improvement of the Quality Management System (QMS) according to FDA, GMP, and ISO 9001 requirements. Assist in document control activities, including creation, revision, routing, issuance, and archival of controlled documents. Help manage and track corrective and preventive actions (CAPA) to ensure timely investigation, follow‑up, and closure. Assist in preparing for and conducting internal audits; support readiness for external audits and inspections. Coordinate and track employee training activities to ensure staff remain compliant and current with required qualifications. Support management of deviations, non‑conformances, and audit findings, ensuring documentation is accurate and complete. Assist with implementing and maintaining change control processes, ensuring proper documentation, review, and approval. Collaborate with cross‑functional teams (QA, QC, Manufacturing, Facilities, R&D) to support quality system activities and improvements. Help generate, analyze, and maintain quality metrics and trend reports to support continuous improvement. Assist with administration of quality system software, including user access management, record maintenance, and troubleshooting. Stay informed on evolving regulations, guidance documents, and industry best practices. Required Skills Bachelor's degree in Life Sciences, Engineering, or a related field. Minimum 2+ years of experience in quality systems, quality assurance, or quality operations within a regulated industry (pharmaceuticals, biologics, medical devices, etc.). Knowledge of FDA regulations, GMP guidelines, and ISO 9001 standards. Strong attention to detail and organizational skills. Ability to work independently and collaboratively in a fast‑paced environment. Proficiency in Microsoft Office (Word, Excel, PowerPoint). Experience with QMS or electronic quality system software platforms. Strong written and verbal communication skills for effective cross‑functional collaboration. Preferred / Nice-to-Have Skills Experience supporting audits, CAPA processes, deviations, or change control. Familiarity with electronic document management systems (EDMS) or commercial QMS tools. Experience in a GMP manufacturing, biologics, or cell therapy environment. Exposure to ISO audit practices or participation in internal audits. Ability to analyze quality data, produce reports, and identify trends. Work Environment / Physical Demands Primarily office‑based, focusing on quality system management and documentation activities. Requires prolonged periods of computer use for documentation, reporting, and system administration. Occasional lifting of office materials up to 15 pounds. Ability to move between office and operational areas to support audits and cross‑functional work. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that's transforming lives with every breakthrough. Come Work With Us!At Capricor, you'll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which ****************. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

The anticipated salary range for candidates who will work in San Diego, CA is $72,000 to $90,000 annually. 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 years of experience within the job, type and years of experience within the blood banking industry, education, etc. Job Summary Under minimal supervision of management, Medical Laboratory Scientists perform manufacturing processes in a highly regulated environment-from receipt of unprocessed apheresis platelets, through maintaining accurate records of finished components in preparation to distribute to available inventory. The QC lab CLSs test products across the three stages of production (before, in-process, and final) and review the data to ensure the high quality and maximum efficacy of blood components. Responsibilities Perform essential laboratory responsibilities according to established procedures. Support the SDBB safety, GMP and Quality Plan. Adheres to GMP guidelines. Safely operate laboratory equipment in accordance with established SOPs. Obtain samples for product QC testing and further manufacturing. Perform donor and product quality control evaluations. Perform sterility testing on apheresis platelets and operate Bact/ALERT instrument. Perform pathogen reduction process using illuminator instrument. Operate Hematology analyzer to manufacture platelets using large volume delayed sampling and pathogen reduction methods. Perform pH analysis using pH Meters Perform residual WBC testing using Fluorescence Microscopy method. Perform routine equipment QC and maintenance. Evaluate, gather data, trend, and assess results. Assist in training new personnel and other staff members. Assist in laboratory paperwork documenting information accurately and completely in a timely manner. Complete all tests required for each product. Initiate and participate in the investigations and assess any potential impact on product quality. Conduct retesting of product as needed to support quality investigations. Participate in research projects. Participate in department meetings and educational programs. Review and approve quality control on products, reagents, and various test kits. Receive / Review, Upload and Commit IDM test results. Provide support for the donor notification/look-back process. Perform Iso titration on platelet components. Communicate with production personnel and Quality Assurance department. Assist with validations, special projects, and new process developments. Monitor supply inventory levels and assist with material ordering. Understand and adhere to the policies and standards as developed as part of the San Diego Blood Bank Compliance Program. Perform other related duties as assigned or requested. Working Environment Normal laboratory environment with biohazard precautions. May be exposed to blood or bodily fluids that may be capable of transmitting diseases. May be exposed to chemicals that may be hazardous. May be called on to work or attend meetings at other than routinely scheduled hours. Physical Requirements Must be able to stand or sit long hours. Must be able to work on a computer 4 - 8 hours a day. Must be able to communicate clearly. May be required to lift to 40 pounds. Equipment Used General office equipment (computer, printer, fax, copy machine). Various software systems (Blood Establishment Computer System, Quality Management System). Laboratory equipment, including, but not limited to: Centrifuges. Heat sealers. Scales. Refrigerators/incubators. Sterile Connection Devices. BacT/ALERT 3D analyzer. Hematology cell counter. Illuminators. ADAM rWBC analyzer. pH Meter. Qualifications Education: MLS/MT (ASCP)cm or equivalent experience. CA Clinical Laboratory Scientist (CLS)- Generalist. Experience: Laboratory experience preferred but not required. Understanding of technical aspects of lab department, blood banking concepts, hematology, microbiology, serology, and flow cytometry. Skills: Organized and able to efficiently prioritize and handle multiple tasks at one time to provide a productive workflow. Professional communication both written and oral, which is clear and precise. Provide direct and constant supervision over unlicensed laboratory personnel. Must be detail oriented, well organized and display good time management skills. Ability to perform under pressure and work under stressful situations. Interpersonal skills to establish and maintain professional relationships. The San Diego Blood Bank is an Equal Opportunity Employer. EOE/Minority/Female/Disability/Vets The above statements are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

JOB SUMMARY: Under the supervision of the Admitting Supervisor and the Manager of Admitting, the Insurance Verifier is responsible for verifying benefits for all inpatient, Surgery and observation accounts. The Insurance Verifier is to display courtesy with all patients, staff and visitors and work in a cooperative manner to fulfill the goals of the department and hospital. EDUCATION/TRAINING/EXPERIENCE: Previous hospital experience as an admissions representative preferred.. High School Diploma or Equivalent Preferred. Required upon 90 days hire; BCLS (AHA), AB508

at Glidewell Dental Essential Functions: Performs inspections for products manufactured by dental technicians; performs quality control inspections according to the quality standard procedures. Evaluates each case thoroughly to ensure correct product per Rx specifications. Serves as a liaison between dental technicians and managers. Communicates with colleagues, dental technicians, and managers in a prompt articulate manner on a continuous basis. Relies on extensive technical knowledge to make decisions and accomplish departmental goals. Communicates with supervisors, QC personnel, and technicians about work quality, quality standards, turnaround time, deadlines, and work flow. Provides constructive feedback to all dental technicians in regards to quality of work produced. Ensures high productivity and work quality by problem solving, motivating, and helping technicians. Complies with safety procedures. Seeks advice and input from the manager when needed. Understands all file trees. Sends and receives files to and from specified labs as directed. Trains technicians. Performs other related duties and projects as business needs require at direction of management. Education and Experience: High school diploma or equivalent. Pay Range: $18.69/hr Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell! In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more! Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed. Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.

Under minimal supervision of management, Medical Laboratory Scientists perform manufacturing processes in a highly regulated environment-from receipt of unprocessed apheresis platelets, through maintaining accurate records of finished components in preparation to distribute to available inventory. The QC lab CLSs test products across the three stages of production (before, in-process, and final) and review the data to ensure the high quality and maximum efficacy of blood components.

Under the direction of the NA Quality Team, the Quality Technician is responsible for supporting Inspection and rework of products sold by Johnson Health Tech North America. Duties will include working directly with operations teams to improve quality, supporting the documentation and tracking of defects, and coordinating rework efforts to fix issues as soon as possible in accordance with company policies and procedures. Responsibilities Inspection * First Piece inspection of new SKU's * Targeted Inspection of inventory based on issues found * Inbound, assembly, and outbound quality Rework * Rework finished goods in advance of assembly * Coordinate and train temp labor to assist in rework Training * Face-to-face interaction with the assembly team daily * Research proper assembly procedures and provide assembly instructions * Report defects and train the assembly team on entering defects into tracking system * Lead/Participate in continuous improvement projects Requirements Education: * High school diploma required * Associate degree in technical field preferred * Additional training and/or certifications in quality systems preferred Experience: * Assembly experience preferred * Past experience in an inspection or repair service role preferred Other Requirements: * Proficiency in Office 365 products * SAP experience preferred * Forklift certification * Familiarity with measuring instruments. Examples include: VOM calipers, tension gauges, etc. * Valid drivers license is required * Ability and willingness to travel both domestically and internationally Benefits: We offer an excellent compensation package and team-oriented work environment with growth opportunities. Some of our outstanding benefits include: * Health & Dental Insurance * Company paid Life Insurance * 401(k) * Paid Time Off benefits * Product discounts * Wellness programs EOE/M/W/Vet/Disability #ZR

Job DescriptionDescription: Under the direction of the NA Quality Team, the Quality Technician is responsible for supporting Inspection and rework of products sold by Johnson Health Tech North America. Duties will include working directly with operations teams to improve quality, supporting the documentation and tracking of defects, and coordinating rework efforts to fix issues as soon as possible in accordance with company policies and procedures. Responsibilities Inspection •First Piece inspection of new SKU's •Targeted Inspection of inventory based on issues found •Inbound, assembly, and outbound quality Rework •Rework finished goods in advance of assembly •Coordinate and train temp labor to assist in rework Training •Face-to-face interaction with the assembly team daily •Research proper assembly procedures and provide assembly instructions •Report defects and train the assembly team on entering defects into tracking system •Lead/Participate in continuous improvement projects Requirements: Education: •High school diploma required •Associate degree in technical field preferred •Additional training and/or certifications in quality systems preferred Experience: •Assembly experience preferred •Past experience in an inspection or repair service role preferred Other Requirements: •Proficiency in Office 365 products •SAP experience preferred •Forklift certification •Familiarity with measuring instruments. Examples include: VOM calipers, tension gauges, etc. •Valid drivers license is required •Ability and willingness to travel both domestically and internationally Benefits: We offer an excellent compensation package and team-oriented work environment with growth opportunities. Some of our outstanding benefits include: · Health & Dental Insurance · Company paid Life Insurance · 401(k) · Paid Time Off benefits · Product discounts · Wellness programs EOE/M/W/Vet/Disability #ZR

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 *****************************************

Join our mission-driven Quality team as the Quality Control Inspector at Endologix! WHO WE ARE: Endologix LLC is a California-based global medical device company dedicated to improving patients' lives through innovative therapies for the interventional treatment of vascular disease. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician training-supported by industry-leading clinical evidence. At Endologix, we're driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health. What sets us apart is not just our technology, but our culture. At Endologix, we foster a forward-thinking, mission-driven environment where every team member plays a vital role in advancing patient care. Our values guide how we operate: we prioritize patient outcomes, act with integrity, stay curious and innovative, move boldly in pursuit of excellence, and collaborate across teams and with physicians to achieve exceptional results. As for our people? We empower them with the tools, trust, and continuous learning they need to grow. If you're passionate about making a meaningful difference in healthcare, you'll find purpose and belonging here. ABOUT THE ROLE: We're looking for a Quality Control Inspector to join our mission-driven Quality team. In this role, you'll be responsible for performing inspections of components, subassemblies, and finished medical devices to ensure compliance with quality standards and regulatory requirements. This includes conducting quality checks, performance tests, reviewing documentation, and verifying Device History Records (DHR) for product release in accordance with the medical device Quality Management System (QMS). Responsibilities WHAT YOU'LL DO: * Perform audits, inspections, configuration checks, and functional testing to ensure product quality and compliance with established procedures. * Review and verify lot history records for completeness, accuracy, and adherence to SOPs; investigate records related to customer experience reports. * Inspect subassemblies, finished products, purchased components, and tools using defined criteria and standard mechanical, and/or electrical measurements. * Conduct product rework on subassemblies or finished goods as required. * Accurately document inspection and testing results in compliance with Good Documentation Practices (GDP). * Review Device History Records (DHR) for compliance with established procedures and GDP requirements. * Identify issues and provide initial recommendations for corrective actions or process improvements to supervisors. * Perform product testing to ensure conformance to quality standards. * Work within a cleanroom environment, following all applicable protocols and safety requirements. * Perform temperature and particle count monitoring; manage ERP (QAD) and MES application transactions; handle multiple tasks efficiently in a fast-paced manufacturing environment. * Perform other duties as assigned by the supervisor. * Demonstrate punctuality, reliability, and a strong work ethic. Qualifications WHAT YOU'LL BRING: Education: * High School Diploma or equivalent required. Experience: * 1-5 years of Quality Control experience, preferably in the medical device industry. Skills/Competencies: * Ability to understand and follow technical procedures, work instructions, and basic specifications related to the inspection of products and components. * Skill in identifying relevant information in technical drawings and documents and reporting any discrepancies to the supervisor. * Familiarity with applicable quality standards and willingness to learn about specific regulations under supervision * Mechanical aptitude and working knowledge of measurement instruments. * Strong written and verbal communication skills for reports, correspondence, and presentations. * Mathematical proficiency in fractions, percentages, ratios, and proportions. * Problem-solving skills with the ability to work in a cross-functional environment and manage multiple priorities. WHAT WE OFFER: At Endologix, we know that great work starts with great people - and people do their best when they feel valued and supported. That's why we offer competitive pay, solid benefits, career growth, a culture that genuinely cares, and the flexibility you need to thrive both at work and at home. But more than that, we offer purpose. You'll be part of a team that's making a real impact on patients' lives. When you join us, you're not just taking a job, you're building a meaningful career with a team that's invested in your success. The compensation package includes: * Hourly rate of $24.03/hr-$29.44/hr * Discretionary bonus * Equity participation as approved by Board of Directors (4-year vesting schedule) * Comprehensive health, dental, and vision insurance plans * Generous PTO and holiday schedule * 401(k) retirement plan with company match Plus: * Employee wellness initiatives and mental health support * Collaborative and inclusive company culture focused on impact and innovation * Opportunities for career growth and internal mobility HOW WE LEAD WITH OUR CORE VALUES: * Patient Outcomes Drive Us: We improve lives with every advancement we deliver. * Integrity Defines Us: We do what's right, stay transparent, prioritize quality, and own our actions. * Innovation Advances Us: We stay curious, adaptable, and push boundaries. * Boldness Propels Us: We take smart risks and are unafraid in our pursuit of excellence. * Collaboration Unites Us: We partner across teams and with physicians to drive exceptional results. OUR COMMITMENT TO EQUAL OPPORTUNITY & VETERAN INCLUSION: Endologix LLC is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. As a federal contractor, Endologix LLC is committed to taking affirmative action to recruit, employ, and advance in employment qualified individuals with disabilities and protected veterans.

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Position Description Are you detail-oriented with a passion for maintaining the highest standards of quality in manufacturing? Join Applied Medical as a Quality Control Inspector and play a vital role in ensuring the excellence of our raw materials, components, and finished products. As part of our Quality Assurance team, you'll utilize precision measurement tools, review engineering documentation, and uphold strict compliance with industry standards. Key Responsibilities: * Conduct thorough inspection activities, including receiving, in-process, and final product verification. * Assess raw materials, components, subassemblies, and finished products for adherence to standards, guidelines, and specifications outlined in company procedures. * Interpret engineering drawings, shop order operations, and process controls to ensure accuracy in production. * Inspect products and materials following standard operating procedures and work instructions. * Utilize technical measuring devices to confirm product conformance to defined specifications. * Document and report nonconforming materials, ensuring accurate record-keeping. * Maintain detailed inspection results using data management software. Position Requirements * Forklift certified and/or willingness to learn. * 2+ years of experience working within quality management systems (ISO 9001, ISO 13485, or 21 CFR Part 820). * Ability to read, write, and communicate in English effectively. * Understanding and adherence to Applied Medical's Quality Systems and training guidelines. * Compliance with safety rules and company policies. * Ability to work Monday through Friday 8:00am - 4:30pm. Preferred * Hands-on manufacturing experience, particularly within the medical device industry. Benefits * Competitive compensation range: $18 - 23 / hour (California). * Comprehensive benefits package. * Training and mentorship opportunities. * On-campus wellness activities. * Education reimbursement program. * 401(k) program with discretionary employer match. * Generous vacation accrual and paid holiday schedule. Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply. Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. All compensation and benefits are subject to plan documents and written agreements. Equal Opportunity Employer Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.

GENERAL INFORMATION Quality Inspector (II, III, or Senior) Department: Quality Assurance Reports to: Quality Engineering Purpose of the Job This Quality Inspector position will report to Quality Engineering. Main responsibilities include performing incoming inspections of materials/parts/products and reviewing and approval of manufacturing batch records and inspection records. This position will require to perform disposition of materials/parts/products. As a Quality Inspector, you will also support Quality Engineering with other Quality Management System (QMS) activities, such as assisting with environmental monitoring and quality metrics. Major Duties and Responsibilities Interpret drawings and specification documents. Perform incoming inspection of materials/components/subassemblies/finished products following standard operating procedures and using standard inspection tools, including the MicroVu and Keyence. Determine inspection sample size based on procedures, specifications, and standards. Help develop inspection methods, including automated inspection programs using the MicroVu and Keyence. Review/approve executed batch records for manufacturing and inspection records in accordance to QMS procedures and Good Documentation Practices. Approve/perform final disposition of materials/components/subassemblies/finished products. Assign and apply expiration dating labels to materials/parts/products, as per specifications/quality procedures. Initiate Non-Conformance Material Reports (NCMRs) and deviations when discrepancies are observed during inspections and record review process. Report discrepancies and issues to QA Engineering and affected function(s). Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order. Maintain accurate records as per Document Control procedures. Support training of IQC personnel. Assist with performing environmental monitoring of Controlled Environment Rooms (CERs), as needed. Support Quality in the collection of quality metrics data. Interact closely with different functions of the organization. Education and/or Job Experience 2-5 years of experience performing inspections and reviews/approvals of manufacturing batch records/inspection records Government Regulated Environment experience such as FDA and ISO 13485 Must have adequate computer experience (knowledge of Microsoft Word, Excel) Experience working in a cGMP environment Skills and Specifications Attention to detail and organizational skills Good interpersonal and communication skills Ability to work as a part of a team and promote a team environment

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Position Description The Quality Inspector plays a critical role in maintaining the safety, reliability, and compliance of Applied Medical's medical devices following clinical use. This post-market quality inspector position ensures that returned products meet Applied Medical's stringent quality standards while supporting patient safety and continuous product improvement. Working within an ISO 13485 and FDA-regulated environment, the Quality Inspector performs detailed inspections, documentation, and collaboration with cross-functional teams to support ongoing product integrity and regulatory compliance. Key Responsibilities * Inspect and assess returned medical devices to verify condition, cleanliness, and compliance with safety and decontamination standards. * Use calibrated measuring tools to confirm product integrity against specifications. Document findings in Applied Medical's enterprise resource planning (ERP) and electronic quality management system (eQMS) platforms with accuracy and traceability. * Collaborate cross-functionally with the Servicing, Regulatory Affairs, and Customer Relations teams to resolve documentation discrepancies and product concerns. * Maintain compliance with applicable regulatory standards, including 21 CFR Part 820, ISO 9001, and ISO 13485. * Support continuous improvement initiatives by contributing feedback. * Adhere to safety protocols when handling decontaminated or potentially biohazardous materials in accordance with bloodborne pathogen procedures. Success in This Role Looks Like * Conducts accurate and efficient inspections that uphold Applied Medical's quality and safety standards. * Contributes to clear, compliant, and timely documentation that supports post-market surveillance and regulatory reporting. * Demonstrates precision, consistency, and accountability in all inspection and verification activities. * Builds strong working relationships with cross-functional partners to resolve quality issues and improve processes. * Supports Applied Medical's mission of delivering reliable, high-quality devices that advance patient care and clinical outcomes. Position Requirements This position requires the following skills and attributes: * High school diploma or equivalent education. * Minimum of two years of experience in quality assurance or inspection within a regulated manufacturing environment (e.g., medical device, pharmaceutical, or aerospace). * Working knowledge of ISO and FDA regulatory frameworks, including 21 CFR Part 820. * Strong analytical skills with meticulous attention to detail. * Proficiency in ERP and eQMS systems for data entry and documentation (e.g., SAP). * Clear written and verbal communication skills in English. * Ability to lift between fifteen and twenty-five pounds on an occasional to regular basis. * Organizational discipline and the ability to manage time effectively in a fast-paced environment. Preferred The following skills and attributes are preferred: * Experience working in a medical device manufacturing or clinical servicing environment. * Familiarity with bloodborne pathogen protocols, product decontamination, and sterilization processes. * Exposure to continuous improvement methodologies such as Lean or Six Sigma. * Understanding of ISO 13485 quality systems and regulatory documentation practices. Benefits * Competitive compensation range: $18 - 23 / hour (California). * Comprehensive benefits package. * Training and mentorship opportunities. * On-campus wellness activities. * Education reimbursement program. * 401(k) program with discretionary employer match. * Generous vacation accrual and paid holiday schedule. Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply. Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. Equal Opportunity Employer Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates.

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Position Description Are you detail-oriented with a passion for maintaining the highest standards of quality in manufacturing? Join Applied Medical as a Quality Control Inspector and play a vital role in ensuring the excellence of our raw materials, components, and finished products. As part of our Quality Assurance team, you'll utilize precision measurement tools, review engineering documentation, and uphold strict compliance with industry standards. Key Responsibilities: * Conduct thorough inspection activities, including receiving, in-process, and final product verification. * Assess raw materials, components, subassemblies, and finished products for adherence to standards, guidelines, and specifications outlined in company procedures. * Interpret engineering drawings, shop order operations, and process controls to ensure accuracy in production. * Inspect products and materials following standard operating procedures and work instructions. * Utilize technical measuring devices to confirm product conformance to defined specifications. * Document and report nonconforming materials, ensuring accurate record-keeping. * Maintain detailed inspection results using data management software. Position Requirements * 2+ years of experience working within quality management systems (ISO 9001, ISO 13485, or 21 CFR Part 820). * Ability to read, write, and communicate in English effectively. * Understanding and adherence to Applied Medical's Quality Systems and training guidelines. * Compliance with safety rules and company policies. Preferred * Hands-on manufacturing experience, particularly within the medical device industry. Benefits * Competitive compensation range: $18 - 23 / hour (California). * Comprehensive benefits package. * Training and mentorship opportunities. * On-campus wellness activities. * Education reimbursement program. * 401(k) program with discretionary employer match. * Generous vacation accrual and paid holiday schedule. Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply. Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. All compensation and benefits are subject to plan documents and written agreements. Equal Opportunity Employer Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.