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  • Quality Supervisor

    Omni One 4.5company rating

    Quality systems specialist job in Columbus, OH

    Quality Supervisor - Automotive Industry Columbus, OH $85,000 - $95,000 Bonus and excellent benefits Are you a visionary leader with a passion for driving excellence and innovation? We're on the lookout for a dynamic Quality Engineering Leader to lead and inspire a talented team within our esteemed automotive corporation. Join a company with a rich history of producing exceptional products and an unwavering commitment to continuous improvement. With a solid customer base and a forward-thinking culture, we're primed for long-term success. Enjoy an exciting career with outstanding benefits, job security, and the opportunity to make a lasting impact! Why You'll Love It Here:Comprehensive Benefits Package Job Stability: Join a company with a proven track record and a strong reputation Growth Potential: Lead, develop, and make strategic changes that will shape the future Key Responsibilities:Lead and Develop: Inspire and guide a talented quality team to reach new heights Manage: Supplier quality programs and processes for new model launch Enhance Quality Systems: Drive the implementation and continuous improvement of quality systems Improve Process Controls: Identify and optimize key processes to maintain top-tier standards Engage on the Shop Floor: Be hands-on in resolving quality issues and driving improvements Supervise Operations: Oversee staffing, training, and daily operations within the quality department Customer Collaboration: Work directly with customers to address issues and drive solutions Cross-Department Liaison: Collaborate with various plant departments to ensure seamless operations What We're Looking For:Proven leadership skills to inspire and drive teams to success Expertise in PPAP, APQP, FMEA, and root cause analysis Knowledge of IATF and TS16949 standards Bachelor's degree in a relevant field, automotive experience, and a strong, stable work history Previous experience in a quality engineering or supervisory role within an automotive manufacturing environment Excellent communication and organizational abilities Apply Today: Send your resume to ****************** or call us at ************. All inquiries are kept confidential. Omni One specializes in placing Engineers and Technical Professionals. Our services are employer-paid (at no cost to you).
    $85k-95k yearly 1d ago
  • Quality Manager

    Invisible Technologies 4.0company rating

    Remote quality systems specialist job

    About Invisible Invisible Technologies makes AI work. Our end-to-end AI platform structures messy data, automates digital workflows, deploys agentic solutions, measures outcomes, and integrates human expertise where it matters most. Our platform cleans, labels, and structures company data so it is ready for AI. It adapts models to each business and adds human expertise when needed, the same approach we have used to improve models for more than 80% of the world's top AI companies, including Microsoft, AWS, and Cohere. Our successes span industries, from supply chain automation for Swiss Gear to AI-enabled naval simulations with SAIC, and validating NBA draft picks for the Charlotte Hornets. Profitable for more than half a decade, Invisible reached $134M in revenue and ranked as the number two fastest growing AI company on the 2024 Inc. 5000. In September 2025, we raised $100M in growth capital to accelerate our mission of making AI actually work in the enterprise and to advance our platform technology. About The Role As a company redefining operations through AI innovation, our ability to deliver consistently high-quality outcomes is at the core of the value we provide to our clients. We are seeking a detail-oriented and impact-driven Delivery Quality Manager to ensure that our AI training and multilingual data operations maintain the highest standards of accuracy, consistency, cultural relevance, and linguistic excellence. In this role, you will work in close collaboration with some of the most influential organizations in generative AI and LLM development. You'll act as a quality guardian across our enterprise delivery programs-ensuring that our human-in-the-loop (HITL) workflows, advanced multilingual data generation processes, and high-touch client services operate at peak precision and reliability. You'll partner with Operations Managers, project leads, and client stakeholders to define and implement robust quality assurance protocols, drive performance improvements, and cultivate a culture of continuous enhancement across delivery teams. From proactive QA audits to root-cause analyses, you'll play a mission-critical role in maintaining the trust and satisfaction of some of the world's most forward-thinking AI labs and companies. This position requires an analytical mindset, a sharp eye for detail, and a passion for operational excellence. Success in this role means not only identifying problems-but creating scalable systems and frameworks to prevent them. You'll be on the front lines of building the standards that shape how human-generated data trains and improves the AI models of tomorrow. What You'll Do Cross-Functional Collaboration: Work closely with Delivery, Product, Engineering, and Customer Success teams to address quality concerns and build preventive measures. Process Optimization: Identify process inefficiencies or gaps in both AI data and multilingual pipelines, and work with relevant teams to streamline operations and improve delivery accuracy and speed. Reporting & Insights: Generate regular reports and insights on delivery performance trends, multilingual QA activities, and recommendations to leadership. Quality Assurance Strategy: Develop and implement comprehensive QA frameworks for large-scale AI data and multilingual delivery workflows, aligned with industry best practices and internal standards. Tooling & Automation: Evaluate and implement QA tools and automation frameworks to streamline quality checks and reduce manual errors across delivery pipelines. What We Need Bachelor's degree in Operations Management, Engineering, Computer Science, Linguistics, or related field. Proven expertise in language QA concepts and workflows, including linguistic quality assessment, cultural adaptation, and managing multilingual projects. 5+ years of experience in quality assurance, service delivery, or operations, preferably in a tech, localization or AI-focused environment. Deep understanding of delivery and multilingual lifecycles, QA methodologies, and performance metrics. Experience working in agile environments and using project management tools Strong analytical skills with experience in data-driven decision-making. Familiarity with AI/ML concepts and workflows is a strong plus. What's In It For You Invisible is committed to fair and competitive pay, ensuring that compensation reflects both market conditions and the value each team member brings. Our salary structure accounts for regional differences in cost of living while maintaining internal equity. For this position, the annual salary ranges by location are: Tier 1$132,000-$147,300 USDTier 2$120,000-$134,000 USDTier 3$108,000-$120,000 USD You can find more information about our geographic pay tiers here. During the interview process, your Invisible Talent Acquisition Partner will confirm which tier applies to your location. For candidates outside the U.S., compensation is adjusted to reflect local market conditions and cost of living. Bonuses and equity are included in offers above entry level. Final compensation is determined by a combination of factors, including location, job-related experience, skills, knowledge, internal pay equity, and overall market conditions. Because of this, every offer is unique. Additional details on total compensation and benefits will be discussed during the hiring process What It's Like to Work at Invisible: At Invisible, we're not just redefining work-we're reinventing it. We operate at the intersection of advanced AI and human ingenuity, pushing the boundaries of what's possible to unlock productivity and scale. Ownership is at the core of everything we do. Here, you won't just execute tasks-you'll build, innovate, and shape the future alongside world-class clients pushing the boundaries of AI. We expect bold ideas, relentless drive, and the ability to turn ambiguity into opportunity. The pace is fast, the challenges are big, and the growth is unmatched. We're not for everyone, and we're okay with that. If you're looking for predictable routines, this isn't the place for you. But if you're driven to create, thrive in dynamic environments, and want a front-row seat to the AI revolution, you'll fit right in. Country Hiring Guidelines: Invisible is a hybrid organization with offices and team members located around the world. While some roles may offer remote flexibility, most positions involve in-office collaboration and are tied to specific locations. Any location-based requirements or hybrid expectations will be communicated by our Talent Acquisition team during the recruiting process. AI Interviewing Guidelines: Our hiring team thoughtfully uses AI to support an efficient, engaging, and inclusive interview process. Since AI can also be a helpful tool for candidates, we've outlined expectations for using it ethically throughout your interview journey. Click here to learn more about how we use AI and our guidelines for candidates. Accessibility Statement: We're committed to providing reasonable accommodations for individuals with disabilities. If you need assistance or accommodation due to a disability, please contact our Talent Acquisition team during the recruitment process at accommodation@invisible.email . Equal Opportunity Statement: We're an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or veteran status, or any other basis protected by law. Due to a high volume of candidates, Invisible may use automated decision-maker technologies to filter candidates based on response to our application questions and other provided information. Our use of automated decision-making enables us to be efficient by providing a manageable list of possible candidates that meet our mandatory hiring criteria. If you object to our use of automated decision-making please contact us.
    $132k-147.3k yearly Auto-Apply 13d ago
  • Quality Assurance Specialist

    STAQ Pharma Inc. 3.7company rating

    Quality systems specialist job in Columbus, OH

    Job Description STAQ Pharma is currently hiring for a Quality Assurance Specialist to join our team here in Columbus Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company's mission and vision. Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects. Duties/Responsibilities: Lead the document control program to ensure procedures meet CGMP requirements Manage training documentation and track employee compliance with training plans Issue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc. Support in-process and finished product lot acceptance sampling and inspection Participate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplier Develop and implement corrective and preventive actions geared toward continuous process improvements Support the finished product label printing and issuance process Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements Provide supplier related support to production and receiving inspection team Other duties and tasks, as assigned Required Skills/Abilities: Excellent independent judgement and interpersonal skills Excellent mathematical, written communication, and verbal communication skills Strong technical writing skills and attention to detail Knowledge of and proficiency in the use of basic statistics Familiarity with Good Manufacturing Practices and FDA Regulations Supplier Auditing experience Knowledge of ERP System Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus Education and Experience: 2-5 years of Quality Assurance experience Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing B.S. or B.A. on Sciences or a relevant field or equivalent experience Professional certification in Quality Engineering or Quality Auditing, preferred Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.
    $53k-83k yearly est. 28d ago
  • Customer Quality Manager

    SMA America 4.9company rating

    Remote quality systems specialist job

    Why Work at SMA America At SMA America, we believe in Energy that Changes . Since 1981, we've been developing innovative solar technology that simplifies, secures, and enhances the performance of photovoltaic systems - all while pushing the boundaries of what's possible in clean energy. But we're not just transforming power - we're empowering people. We've built a culture where bold ideas are welcomed, collaboration is second nature, and your career growth truly matters. With our Rocklin, CA headquarters as the hub, we offer a hybrid work model, competitive benefits, and a team-driven environment where your impact is seen and felt. Whether you're a sales expert, service pro, or engineering innovator, if you're ready to join a purpose-driven team committed to shaping the future of energy - we'd love to meet you. PURPOSE OF POSITION The Customer Quality Manager is accountable for the substantial timely management, tracking and coordination of any customer related quality topics in the US. The position ensures alignment and close teamwork with the customer quality team at the headquarters, supporting fast communication, a unified direction and mindset. PRIMARY DUTIES / RESPONSIBILITIES Leads, drives and tracks quality activities by supporting complete problem resolution of product failures with customer impact. Supervises and manages special projects with customer quality impact as needed or required. Initiates and manages the verification process of product problems or failures in a global network. Drives and tracks corrective actions utilized in the defined 8D steps. Manages, coordinates and tracks remedial actions with Supplier Quality Managers, Engineering, Service personnel as required in resolving product quality issues. Tracks and follows up on quality-related actions with all involved functions (Sales, Service, Production, Development) and escalates if deadlines are missed or deliverables are not met. Interfaces with customers to drive continuous quality improvement and facilitates customer audits or assessments upon request. Participates in on-site evaluations of non-conforming products in the field. Prepares documentation for decision making process within the global Quality Circle process. Applies statistical methods to track, trend, and analyze quality data related to non-conforming products reported by customers. Interfaces with international colleagues in the continual improvement of product/system/solution quality. Other duties as may be assigned by supervisor or management. REQUIRED RELEVANT PROFESSIONAL EXPERIENCE Bachelor's degree in engineering or electrical engineering (Master's preferred) or related field, or similar education At least 10 years of experience in the customer quality management field in a manufacturing environment Expertise in 8D method for corrective action and the quality tools 5-Why, Ishikawa diagramming, and pareto analysis. Profound project management skills especially including action tracking and special project management. Excellent communication skills in negotiations with critical / opposing parties. Ability to present information to formal mid/high-level management boards on quality issues. Excellent communication, leadership, and cross-functional collaboration skills. Strong skills in office suite: Word, Excel, Project, PowerPoint, and statistical software packages. Ability to travel occasionally. Working knowledge in JIRA, Salesforce, SAP, and CRM is a plus. Acts with an entrepreneurial mindset Certification in quality management (e.g., CQE, CQA, Six Sigma). Experience in solar, automotive, aerospace, electronics, or similar regulated industries. WE OFFER The salary range for this position is $104,000-134,000 per year, dependent upon experience Comprehensive benefits including health, dental and vision coverage (including $0 premium options) Dedicated Hybrid Schedule: In-Office Tuesday and Thursdays; remote on Monday, Wednesday, and Fridays 401(k) plan with company match Opportunities for professional development and training Inclusive, collaborative, and innovative work environment Our EEO Policy We are an equal opportunity employer and we make our employment decisions on the basis of merit and without regard to one's race, color, creed, sex (includes gender, pregnancy, childbirth and related medical conditions), gender identity, religion, marital status, age (over 40), national origin or ancestry, physical or mental disability (includes HIV/Aids), medical condition (cancer, genetic characteristics), veteran's status, sexual orientation, or any other consideration made unlawful by law. In accordance with applicable law protecting qualified individuals with known disabilities, SMA will attempt to reasonably accommodate qualified applicants with known disabilities, unless doing so would create an undue hardship on SMA. Any qualified applicant with a disability who believes he or she requires an accommodation in order to perform the essential functions of the job for which he or she is applying should identify the accommodation(s) needed in the application. Our Privacy Policy During your job application or recruitment process with us: (a) SMA may collect your personal information directly from you, such as when you submit your application and resume on our online portal or when you have job interviews with us. We may also obtain your personal information from third parties, including but not limited to your former employers, background or employment check service providers or third-party recruiters; and, (b) SMA may use or process applicants' personal information for relevant purposes including but not limited to general communications with you, identity verification, background or employment checks, determination of eligibility, and making hiring decisions. For successful job applicants who become SMA's staff, we may retain and integrate your personal information collected during the recruitment process into your records at SMA. For unsuccessful job applicants, [SMA may retain your application for internal records or for future recruitment purposes]. If you are a California resident, you have specific rights regarding your personal information under the California Consumer Privacy Act of 2018, as amended including by the California Privacy Rights Act of 2020, and its implementing regulations (the “CCPA”). This Company Personnel and Covered Individuals Privacy Notice for California Residents issued by SMA is applicable to you and explains your CCPA rights and our collection, use or disclosure of your personal information. If you have any question regarding our privacy policy, please contact us at US_DataPrivacy@sma-america.com
    $104k-134k yearly Auto-Apply 47d ago
  • Regional Quality Manager (Midwest)

    Solv Energy, LLC

    Remote quality systems specialist job

    SOLV Energy is an engineering, procurement, construction (EPC) and solar services provider for utility solar, high voltage substation and energy storage markets across North America. The Regional Quality Manager will be responsible for overseeing and managing the quality assurance and control processes for all PV EPC projects in their assigned region. The individual will ensure that all projects meet the highest standards of quality and comply with industry regulations and company standards. The Regional Quality Manager will primarily work in an office setting but will also be required to visit project sites in their assigned region (Midwest) regularly to perform training and instruction to the field teams, conduct audits and First Article Inspections. The role also involves travel to meet with clients, suppliers, and regulatory agencies, and occasionally travels to various locations for seminars, conferences and meetings. : *This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned Position Responsibilities and Duties: Develop and implement quality plans that align with SOLV Energy's Quality Management System, SOLV SOPs and contract requirements for each of their projects. Establish, maintain, and continuously improve quality systems to ensure compliance with industry standards, regulatory requirements, and customer expectations. Monitor project quality: Conduct regular inspections and audits of ongoing and completed projects to ensure adherence to quality standards, AHJ's requirements, manufacturers installation instructions, code compliance; identifying areas for improvement. Manage quality control processes: Oversee the testing, inspection, and evaluation of materials, components, systems and processes used in PV projects within your region. Train and support: Provide direct training and guidance to project teams on quality assurance and control practices, SOLV Energy's Quality SOP's, SWI's, MOP's and reference guides, ensuring that all team members understand and follow established procedures. Collaborate with stakeholders: Work closely with project managers, engineers, suppliers, and clients to address quality-related issues and ensure customer satisfaction. Document and report findings: Maintain detailed records of quality inspections, audits, and corrective actions, and prepare regular reports for management and clients. Become proficient in the use of SOLV's proprietary “Sunscreen” software to train project teams in documentation processes and to initiate, report and document all quality matters on the projects in the designated region. Conduct frequent, formal audits on documentation compliance, reporting methods, installation processes/procedures and methods, material handling, and vendor product performance. Conduct Root Cause Analysis when needed. Utilizing both 5-Why or 8D methods, depending on circumstance, conduct and document thorough RCA to identify quality issues on projects. Create, implement and monitor formal CAPA's based on results of the RCA. Continuous improvement: Identify opportunities for process improvements and implement corrective actions to enhance overall project quality and efficiency. Ensure compliance: Stay up-to-date with industry standards, regulatory requirements, and best practices, and ensure that all projects adhere to relevant guidelines and regulations. Minimum Skills or Experience Requirements: Experience: Minimum of 5 years of experience in quality management, preferably in the solar or renewable energy industry. Certifications: Quality management certifications such as ASQ Certified Auditor, ISO 9001, Six Sigma, or PMP are highly desirable. Bachelor's degree in engineering, OSHA 10, 30, Journeyman, etc. are all highly desirable. Skills: Strong knowledge of quality assurance and control methodologies. Strong knowledge of electrical construction and electrical safety. Experience with construction drawings and installation procedures. Excellent analytical and problem-solving skills. Effective communication and interpersonal skills. Proficient in quality management software and tools. Ability to work as part of a team. SOLV Energy Is an Equal Opportunity Employer At SOLV Energy we celebrate the power of our differences. We are committed to building diverse, equitable, and inclusive workplaces that improve our communities. SOLV Energy prohibits discrimination and harassment of any kind against an employee or applicant based on race, color, age, religion, sex, sexual orientation, gender identity or expression, marital status, national origin, or ethnicity, mental or physical disability, veteran status, parental status, or any other characteristic protected by law. Benefits: Employees (and their families) are eligible for medical, dental, vision, basic life and disability insurance. Employees can enroll in our company's 401(k) plan and are provided vacation, sick and holiday pay. Compensation Range: $116,812.00 - $146,016.00 Pay Rate Type: Salary SOLV Energy does not accept unsolicited candidate introductions, referrals or resumes from third-party recruiters or staffing agencies. We require all third-party recruiters to communicate exclusively with our internal talent acquisition team. SOLV Energy will not pay a placement fee to any third-party recruiter or agency that has not coordinated their recruiting activity with the appropriate member of our internal talent acquisition team. In addition, candidate introductions or resumes can only be submitted to our internal talent acquisition recruiting team if a signed vendor agreement is already on file and the third-party recruiter or agency has received formal instructions from our internal talent acquisition team to submit candidates for a particular job posting. Any unsolicited candidate introductions, referrals or resumes sent by third-party recruiters to SOLV Energy or directly to any of our employees, or received through our website or career portal, will be considered property of SOLV Energy and will not be eligible for a placement fee. In the event a third-party recruiter submits a resume or refers a candidate without a previously signed vendor agreement, SOLV Energy explicitly reserves the right to pursue and hire the candidate(s) without financial liability to such third-party recruiter. Job Number: J10751 If you're interested in a meaningful career with a brighter future, join the SOLV Energy Team.
    $116.8k-146k yearly Auto-Apply 60d+ ago
  • Quality Manager - Medical Device Startup (Class II)

    Wearlinq

    Remote quality systems specialist job

    WearLinq is hiring! We are a growing medical device startup commercializing an FDA Class II device. We're seeking a proactive, hands-on Quality Manager to build, lead, and continuously improve our Quality Management System (QMS). This role is ideal for a quality professional who thrives in a fast-paced, early-stage environment and wants to directly influence product development, regulatory readiness, and company culture. You will be responsible for maintaining compliance with FDA 21 CFR Part 820 and ISO 14971, while also supporting design control, supplier qualification, risk management, and post-market processes. Key Responsibilities Quality System Development & Compliance Maintain and improve a right-sized QMS tailored to a startup environment while ensuring compliance with FDA requirements. Manage document control, change control, training records, equipment calibration, and supplier quality. Prepare for and lead FDA and ISO audits once the company moves toward commercialization. Design & Development Support Partner closely with R&D to embed quality into design control activities-design reviews, verification and validation planning, risk management, and design history file maintenance. Ensure design documentation aligns with regulatory expectations for Class II devices. Manufacturing & Supplier Quality Develop supplier qualification and monitoring processes appropriate for startup scale. Support process validation and production readiness activities with manufacturing partners. Ensure inspection and release processes are defined and traceable. CAPA, Nonconformance, and Risk Management Lead root cause analysis, corrective/preventive actions, and trending. Maintain the risk management file per ISO 14971 throughout the product lifecycle. Post-Market Readiness Contribute to complaint handling, vigilance, and post-market surveillance systems as commercial activities begin. Help establish systems for field actions and product improvements. Leadership & Culture Serve as the company's primary quality lead and FDA liaison. Provide training and guidance to cross-functional teams on quality principles. Promote a culture of compliance, ownership, and continuous improvement. Qualifications Education & Experience Bachelor's degree in engineering, life sciences, or related technical field (advanced degree preferred). 5+ years of experience in medical device quality assurance; startup or small-company experience strongly preferred. Proven knowledge of FDA 21 CFR Part 820 and ISO 14971. Hands-on experience with design control, risk management, and process validation for Class II devices. Experience leading or supporting FDA inspections or ISO audits. Familiarity with electronic QMS tools or willingness to implement one. Skills & Attributes Entrepreneurial mindset with ability to build processes from the ground up. Excellent communication, organization, and problem-solving skills. Comfortable balancing regulatory rigor with startup agility. Strong cross-functional collaboration with R&D, operations, and regulatory teams. Preferred Certifications Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) a plus. ISO 13485 Lead Auditor certification a plus. Compensation & Benefits Competitive startup compensation (salary + potential equity). Health, dental, and vision insurance. Remote work option. Professional growth opportunities as the company scales.
    $97k-157k yearly est. 47d ago
  • Manager, Quality GMP

    Mineralys Therapeutics

    Remote quality systems specialist job

    “Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit ************************ Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. The GMP Quality Manager is responsible for overseeing all Quality Management System (QMS) activities within a Good Manufacturing Practice (GMP)-regulated environment. This role ensures that manufacturing, testing, packaging, and distribution activities comply with applicable regulatory requirements (FDA, EMA, ICH, etc.). The GMP Quality Manager supports GMP leadership in quality assurance, drives continuous improvement, and supports successful GMP inspections and audits. Principal Responsibilities 1. Batch Review & Product Release · Oversee review and approval of batch records, analytical data, and supporting documentation. · Ensure timely disposition of materials, intermediates, and finished products. · Support investigations of out-of-specification (OOS), out-of-trend (OOT), and deviation events. 2. Vendor and Site Oversight · Support qualification, periodic review, and auditing of GMP vendors. · Review vendor and site quality issues, change control, deviations, and CAPAs. 3. Audit & Inspection Readiness · Support the planning, conduct, and follow up on internal GMP audits and GMP external vendor audits. · Review audit schedules, reports, and CAPA tracking. 4. Training & SOP Oversight · Support the development and maintenance of GMP training programs for employees. · Support the development, review and maintenance of SOPs. 5. Quality Management System · Support the development, implementation, and maintenance of the Quality Management System (QMS). · Ensure compliance with GMP regulations, internal procedures, and industry standards. · Manage document control, change control, deviation investigations, CAPAs, and product release processes. · Track and analyze quality metrics to identify trends and opportunities for improvement. 6. Continuous Improvement · Lead quality improvement initiatives to enhance compliance, efficiency, and product quality. · Implement risk management tools (e.g., FMEA, risk assessments) to support sound decision-making. Skills and Attributes Velocity - Drive Speed with Purpose Foresight & Acceleration Manage Tight Timelines Clear Decision-Making in Ambiguity Data-Driven Decision Making - Ground Strategy in Evidence Data Interpretation Metrics-Oriented Agile Mindset - Embrace Iteration and Change Adaptability to Shifting Development Plans Iterative Planning & Engagement Frictionless Execution - Simplify the Path to Results Operational Clarity & Precision Lean, Cross-Functional Collaboration Strategic Communication Autonomy - Lead with Ownership and Accountability · Self-Directed and Proactive · Trusted Decision Maker Travel This position requires up to 20 % travel. Frequently travel is outside the local area and overnight. Some of the travel may be international. Education and Experience Bachelor's degree in life sciences, Engineering, Pharmacy or related discipline 5-8+ years of QA experience in biotech/pharmaceutical environment; experience in small biotech strongly preferred. Knowledge of GMP and working familiarity with GCP; GLP experience is a plus. Ability to work independently in a fast-moving, resource-lean environment. Ability to interpret global regulatory expectations (FDA, EMA, ICH). Prior involvement in inspection readiness or regulatory submissions. These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $118,000 - $135,000 #LI-Remote
    $118k-135k yearly Auto-Apply 7d ago
  • Quality Systems Specialist

    Hitachi Astemo Ohio Manufacturing

    Quality systems specialist job in Sunbury, OH

    Quality Senior Specialist - Auditing Reports To: Manager I - Quality Systems Job Tasks, Objectives, Prerequisites, Etc. Prerequisites Ability to facilitate groups in root cause problem solving Ability to maintain confidentiality of information Ability to multi-task and handle large volumes of work in a fast-paced environment Ability to travel, occasionally with little notice, and some international travel. Ability to work flexible hours in support of 3-shift operations and video conferences with HQ in Japan. ASQ certifications in Auditing preferred Excellent communication skills with the ability to clearly and directly communicate both written and verbally. Knowledge of AIAG Quality standards (i.e. DFMEA, PFMEA, PCP, PPAP etc.) Microsoft Office expertise in Excel, Word, PowerPoint and Project Root Cause Problem Solving and Corrective Action (8D, 5P, 5 Why) Strong analytical troubleshooting and decision-making Strong follow-up skills Responsibilities 5S 3T compliance Adhere to Safety Policy and practices. Assist Associates with MQ1 Items Assure Conformance to requirements for outside audits Compile and Update Open / Past Due Audit CPR/Issue Reports Conduct Audits as Schedules (Training, Process Assurance, Quality Systems) Conduct Special Audits as required Confirm Audit Countermeasures Confirm Audit Findings Confirm Audit Requirements Coordinate Audits as scheduled (Training, Process Assurance, Layered Process Audits, Quality Systems) Develop and Manage Audit Schedules (Training, Process Assurance, Layered Process Audits, Quality Systems) Develop Checklist (Training, Process Assurance, Layered Process Audits, Quality Systems) Evaluate countermeasures proposed to correct negative trends Follow all company policies and regulations per the associate handbook or other written standards that apply to his / her job assignment Follow up and Analyze Audits (Training, Process Assurance, Layered Process Audits, Quality Systems) Lead special projects and other duties as required. MQ1 Audit System Verification New Hire Orientation Participate in CM meeting for findings from Outside Audits Participate in Outside Audits Perform additional projects assigned by department head and support all shifts as required Perform Product/Process Audits to verify products are manufactured and inspected in accordance with standards. Post Open / Past Due Audit CPR/Issue Reports weekly Prepare Associates for Outside Audits Prepare documentation for Outside Audits Reporting of Open/Past due Audit CPR's / Issues (Training, Process Assurance, Layered Process Audits, Quality Systems) Review completed audits for accuracy Support departmental 6S activities Update and Manage Auditor Training (Training, Process Assurance, Layered Process Audits) Verify / Close Audit findings Verify and Close Audits (Training, Process Assurance, Layered Process Audits, Quality Systems) Work cross-functionally across Operations, R&D, support departments and Corporate Quality to meet internal and customer quality requirements. Enter Layered Process Assurance Audits Review and approve Quality Documentation (PQCT Table II, Manufacturing and Operator Checksheets) Equal Opportunity Employer (EOE) - Qualified applicants will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender, identity, disability, protected veteran status and national origin. At Astemo, we're challenging the status quo with the power of diversity, inclusion, and collaboration. Our goal is to build an inclusive work environment that celebrates the differences of our employees. We want to ensure that every employee feels valued, respected and empowered. We don't just accept difference-we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Astemo is proud to be an equal opportunity employer. If you need a reasonable accommodation to apply for a job at Astemo, please send the nature of the request and contact information to ************************* when applying for the position.
    $55k-73k yearly est. Auto-Apply 43d ago
  • Services Quality Manager (Remote)

    SOLV Energy

    Remote quality systems specialist job

    SOLV Energy is an engineering, procurement, construction (EPC) and solar services provider for utility solar, high voltage substation and energy storage markets across North America. The Services Quality Manager will lead the development and execution of quality assurance strategies for post-construction services in utility-scale solar projects. You'll ensure service excellence, asset performance, and compliance with ISO 55000 standards, focusing on long-term value creation through effective asset lifecycle management. This role is fully remote. Specific location details and expectations will be discussed during the interview process. : *This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned Position Responsibilities and Duties: Quality & Compliance Create and maintain a Quality Management System (QMS) tailored to solar O&M and service operations Ensure compliance with ISO 9001 and ISO 55000 standards, focusing on asset integrity, reliability, and performance Asset Management Alignment Integrate service quality processes with asset management objectives, including preventive maintenance, performance monitoring, and lifecycle optimization Collaborate with engineering and operations teams to ensure service activities enhance asset value and reduce risk Performance & Improvement Define and monitor KPIs for service quality, asset uptime, energy yield, and customer satisfaction Lead root cause analysis and implement corrective and preventive actions for service-related issues Drive continuous improvement initiatives across service workflows, documentation, and field operations Stakeholder Engagement Interface with clients, subcontractors, and internal teams to ensure service delivery meets contractual and regulatory expectations Support client audits and performance reviews with data-driven insights and quality documentation Training & Culture Train service technicians and field staff on quality protocols, ISO 55000 principles, and asset care standards Promote a culture of accountability, safety, and excellence in service execution Minimum Skills or Experience Requirements: 5 plus years in quality assurance or asset management in solar, energy, or infrastructure sectors Strong knowledge of ISO 9001 and ISO 55000 frameworks Experience with solar O&M, SCADA systems, CMMS platforms, and performance analytics Familiarity with asset lifecycle planning, risk-based maintenance, and reliability engineering Certifications in Quality (e.g., CQE, CQA) or Asset Management (e.g., IAM Certificate) preferred Strategic thinking with a systems-based approach to service and asset quality Strong analytical and problem-solving skills Effective communicator with cross-functional leadership capabilities Proficiency in quality tools (e.g., FMEA, Six Sigma, RCA) and data visualization platforms SOLV Energy Is an Equal Opportunity Employer At SOLV Energy we celebrate the power of our differences. We are committed to building diverse, equitable, and inclusive workplaces that improve our communities. SOLV Energy prohibits discrimination and harassment of any kind against an employee or applicant based on race, color, age, religion, sex, sexual orientation, gender identity or expression, marital status, national origin, or ethnicity, mental or physical disability, veteran status, parental status, or any other characteristic protected by law. Benefits: Employees (and their families) are eligible for medical, dental, vision, basic life and disability insurance. Employees can enroll in our company's 401(k) plan and are provided vacation, sick and holiday pay. Compensation Range: $116,733.00 - $142,998.00 Pay Rate Type: Salary SOLV Energy does not accept unsolicited candidate introductions, referrals or resumes from third-party recruiters or staffing agencies. We require all third-party recruiters to communicate exclusively with our internal talent acquisition team. SOLV Energy will not pay a placement fee to any third-party recruiter or agency that has not coordinated their recruiting activity with the appropriate member of our internal talent acquisition team. In addition, candidate introductions or resumes can only be submitted to our internal talent acquisition recruiting team if a signed vendor agreement is already on file and the third-party recruiter or agency has received formal instructions from our internal talent acquisition team to submit candidates for a particular job posting. Any unsolicited candidate introductions, referrals or resumes sent by third-party recruiters to SOLV Energy or directly to any of our employees, or received through our website or career portal, will be considered property of SOLV Energy and will not be eligible for a placement fee. In the event a third-party recruiter submits a resume or refers a candidate without a previously signed vendor agreement, SOLV Energy explicitly reserves the right to pursue and hire the candidate(s) without financial liability to such third-party recruiter. #LI-Remote Job Number: J12262 If you're interested in a meaningful career with a brighter future, join the SOLV Energy Team.
    $116.7k-143k yearly Auto-Apply 34d ago
  • Pennsylvania Quality Manager (Security)

    Surefox Consulting, LLC

    Remote quality systems specialist job

    Surefox is dedicated to being the leader in the physical risk management industry and the company of choice for military veterans searching for a career and culture that values their skills and expertise. Surefox North America Inc is a veteran-owned company that strives to create a diverse and unique culture of trained and talented individuals. We seek an experienced part-time Pennsylvania Quality Manager for Surefox's Security Agency License with integrity and professionalism who can join our team. You will work on security licensing requirements and compliance for Surefox and assist its employees in providing security services in the state. In your day-to-day role as Surefox's Pennsylvania License Manager, you will act as a liaison between Surefox and state compliance and licensing agencies, departments, and employees. You will perform all duties in accordance with Surefox policies and procedures and all state & federal regulations. We are looking for someone who has exceptional observational skills and pays close attention to detail. As we encourage veterans and candidates currently in the military reserve to apply, we welcome all who share the same passion for protection as we do. We are not offering visa sponsorship for this position at this time. What you will do: Comply with all state and local laws for a Pennsylvania Quality Manager regarding security services licensing. Perform all services required by state and local laws for a Pennsylvania Quality Manager regarding security services licensing. Upon request, plan for and meet with state auditors on behalf of Surefox regarding any audits performed or requested by the State licensing agency. Track and manage any compliance and training requirements for Surefox to maintain its Security license with the licensing agency. Track and manage any compliance and training requirements and confirm the active licenses of Surefox employees providing security services. Collaborate with other corporate departments and teams to ensure compliance documentation and requirements are met. Track and report on licensing performance assurance and compliance requirements within the provided guidelines. Prepare reports on accidents, incidents, and suspicious activities involving Surefox clients and/or employees related to security services performed by Surefox. Prepare and submit reports required by state and local agencies, as but not limited to, new hire reporting and termination of employment reporting. Maintain records as required by state and local agencies. Attend project meetings upon request to assess and relay compliance requirements. Work independently and adapt to various work-paces while always maintaining a high level of attentiveness and energy. What is required: Must be a minimum of 25 years of age, a citizen of the United States and have no criminal record. Must maintain a physical address in Allegheny County, Pennsylvania. This must be a street address; it CANNOT be a post office box. Must have a minimum of three (3) years experience as a government investigator, regularly employed detective, a sheriff, a member of the Pennsylvania State Police, or a former member of a police force with a rank above patrolman. Must be able to pass an extensive background check, fingerprinting, and drug screening (Surefox will consider for employment qualified applicants with criminal histories in a manner consistent with all requirements of State and local laws, regulations or codes). Demonstrated competence in reacting to and handling emergencies. Ability to effectively communicate with people at all levels and from various backgrounds. Good judgment with the ability to make timely and sound decisions. Ability to understand and follow both written and verbal instructions. Ability to work independently and as a team member. What is desired: Security experience required. Military background is a plus. Report writing experience preferred. If you share our values and are ready to build your next career, we want to hear from you!
    $76k-109k yearly est. Auto-Apply 60d+ ago
  • Quality Manager

    EXL Talent Acquisition Team

    Remote quality systems specialist job

    EXL (NASDAQ: EXLS) is a global analytics and digital solutions company, recognized for driving business outcomes through data, analytics, and AI. The Quality Manager will be responsible for managing a team of Quality Reviewers, ensuring high-quality insurance survey products, and providing expertise to all stakeholders in the survey process. This role includes a strong focus on leadership, continuous learning, and hands-on involvement in reviewing complex insurance surveys. As part of the EXL Survey and Risk Control team, you will be expected to maintain high standards of professionalism and expertise. For more information on benefits and what we offer please visit us at ************************************************** Experience in Residential or Commercial Survey required. Strong professionalism and emotional intelligence. Excellent analytical and resourcefulness skills. Knowledge of risk assessment and replacement cost estimation. Proficient in written and oral communication. Familiarity with computer equipment, software, and office tools. Ability to manage multiple projects and handle urgent, time-sensitive tasks. Manage a team of Quality Reviewers to ensure the quality of insurance survey reports. Serve as the subject-matter expert in the designated focus area (residential/commercial survey). Lead by example, reviewing complex surveys for quality and providing guidance to the team. Collaborate with Managers, Consultants, and Clients to ensure accurate and thorough survey documentation. Continuously improve skillset through training and learning opportunities. Participate in special projects and be available for ad hoc tasks as needed.
    $76k-109k yearly est. Auto-Apply 12d ago
  • Quality Manager

    Heart of Ohio Family Hea Lth Centers 3.0company rating

    Quality systems specialist job in Columbus, OH

    The primary function of the Quality Program Manager is responsible for providing day to day management of the quality improvement program. Responsible for coordinating activities of quality department staff, suggesting process changes, measuring data, and completing QA activities to achieve organization goals for quality measures for programs like UDS, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, CMC, and individual insurance plan contracts. Reports to: Director of Quality and Clinical Systems Supervises: Yes Dress Requirement: Business Casual Work Schedule: Monday through Friday during standard business hours Times are subject to change due to business necessity Exempt Essential Job Duties and Responsibilities Work with supervisor and members of clinical leadership to develop, implement, monitor, and measure plans to improve processes and quality outcomes. Work with supervisor, clinical leadership, data analytics team, and external data vendor Unity PHM to analyze data, clean data, and perform quality assurance activities. In collaboration with supervisor, Chief Medical Officer, and others, the position is responsible for carrying out system-wide quality programs. Assists with developing, planning, and implementing policies and procedures. Works closely with supervisors, clinical teams, and non-clinical teams for quality improvement efforts. Assists with designing processes for quality improvement purposes. Plays a key role in maximizing revenue from value-based care, pay-for-performance, and risk adjustment contracts. Ensure compliances with program requirements. Examples include individual insurance plan contracts, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, and CMC programs. Focuses on better healthcare value and quality, including the improvement of clinical outcomes, patient experience, patient safety, costs, revenue, productivity, efficiency, employee and physician satisfaction, and process reliability. Leads or participates in meetings related to quality improvement. Coordinate, manage and report UDS measures and other data related to clinical quality. Manages performance improvement projects to assure milestones and key performance indicators are met within defined parameters. Documents the results of projects, and submits other documentation as requested. Develop and motivate department staff. Interview, monitor time and attendance, and manage performance of subordinates. Report on clinical quality measures internally and externally. Provide updates to internal and external stakeholders on progress in quality initiatives. Support data collection and reporting related to grants. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice. Qualifications Education: Bachelor's degree in a related field required. Examples include nursing, healthcare administration, public health, or similar. Certifications such as CPHQ and Lean Six Sigma are beneficial, but not required. Experience: At least four years of experience in the healthcare field, quality, data analytics, and/or management strongly preferred. Master's level education and appropriate background may substitute for some experience. Knowledge of clinical operations including the functions of the front and back-office utilization information systems is preferred. Previous experience working in an outpatient clinic is preferred. Knowledge/Abilities: Excellent communication skills, both written and verbal, are required. Strong organization and time management skills are required. Ability to work independently and demonstrate initiative is required. Proficiency with Microsoft Office is required. Displays cheerful demeanor and makes positive comments when on duty. Works cooperatively with other staff members. Displays sensitivity in a multi-cultural environment. General understanding of the medical billing process is preferred. Equipment Operated : Telephone Computer Printer Fax machine Copier Other office equipment as assigned Other office and medical equipment as assigned Facility Environment : Heart of Ohio Family Health operates in multiple locations, in Columbus, OH. All facilities have a medical office environment with front-desk reception area, separate patient examination rooms, nursing stations, pharmacy stock room, business offices, hallways and private toilet facilities. All facilities are ADA compliant. The patient examination rooms and office area is: kept at a normal working temperature sanitized daily maintains standard office environment furniture with adjustable chairs maintains standard office equipment; i.e., computer, copier, fax machine, etc. at a normal working height Physical Demands and Requirements : these may be modified to accurately perform the essential functions of the position: Mobility = ability to easily move without assistance Bending = occasional bending from the waist and knees Reaching = occasional reaching no higher than normal arm stretch Lifting/Carry = ability to lift and carry a normal stack of documents and/or files Pushing/Pulling = ability to push or pull a normal office environment Dexterity = ability to handle and/or grasp, use a keyboard, calculator, and other office equipment accurately and quickly Hearing = ability to accurately hear and react to the normal tone of a person's voice Visual = ability to safely and accurately see and react to factors and objects in a normal setting Speaking = ability to pronounce words clearly to be understood by another individual
    $69k-90k yearly est. Auto-Apply 60d+ ago
  • Cx - QA/QC Support Specialist (Electrical)

    Vertex Innovations 4.7company rating

    Remote quality systems specialist job

    The Electrical Cx - QA/QC Support Specialist ensures that electrical systems in data center projects meet all quality, safety, and operational requirements. This role combines proactive oversight with responsive problem-solving to ensure that power distribution, grounding, and protection systems are properly designed, installed, tested, and commissioned according to owner expectations, safety standards, and industry best practices. Due to the hazards associated with electrical systems, the specialist supports and coordinates closely with the Energy Marshal, confirming all pre-energization verifications and documentation are complete before startup. Working collaboratively with contractors, engineers, and customer teams, the specialist maintains professionalism under pressure and encourages a cooperative, improvement-oriented culture. The ideal candidate brings deep experience in electrical commissioning, strong safety awareness, and excellent communication and analytical skills. Location: This position is considered remote work, but you are required to be on-site at various client project sites each week as assigned. Key Responsibilities: Commissioning Activities Ensure all electrical systems are installed, tested, and performing in accordance with project specifications, design intent, and applicable codes and standards. Review Factory Acceptance Test (FAT) results for major equipment and track closure of open or deferred items with vendors and site teams prior to functional testing. Conduct proactive inspections through L1-L3 phases to confirm proper handling, installation, and readiness of equipment such as switchgear, PDUs, UPS systems, transformers, and generators. Verify that pre-functional and startup testing (L3) are properly executed and documented by trade contractors, ensuring all Lockout/Tagout (LOTO) and energization activities are coordinated with the site Energy Marshal. Validate integration between electrical, mechanical, and control systems, and oversee corrective actions through retesting prior to handoff to commissioning. Documentation and Reporting Prepare, maintain, and track QA/QC documentation-including inspection reports, checklists, MOPs, and test verification forms-within approved customer platforms. Compile and submit comprehensive commissioning reports and turnover packages that include test results, lessons learned, and as-built documentation. Collaboration and Communication Coordinate daily with project managers, design engineers, contractors, and client representatives to align quality and commissioning activities with project milestones. Participate in commissioning meetings, site walkdowns, and coordination sessions to report progress and identify potential risks or delays. Communicate findings constructively and participate in coordination meetings to report QA/QC progress, readiness, and safety verification prior to energization. Quality Assurance Perform field inspections to verify conformance with drawings, specifications, and best practices, emphasizing electrical safety and energization readiness. Identify and document non-conformances, recommend corrective actions, and support procedural improvements to enhance safety, efficiency, and reliability. System Turnover & Handoff Support Support commissioning handoff from L3 to L4, coordinating documentation and verifying closeout deliverables. Collect and verify O&M manuals, training materials, warranties, and attic stock for turnover to operations. Assist in scheduling and pre-coordination of training for operations staff. Qualifications: Education: Bachelor's degree in Electrical Engineering or a related field. Equivalent experience may be considered. Relevant certifications, such as Certified Commissioning Professional (CCP), Professional Engineer (PE), or LEED Accredited Professional, are a plus. Experience: Minimum of 5 years of experience in electrical systems commissioning, preferably in data centers or mission-critical facilities. Expertise in electrical distribution systems, including low, medium, and high-voltage equipment. Familiarity with industry standards and codes, such as IEEE, NEC, NFPA, and NETA. Skills: Strong technical knowledge of electrical system design, operation, and testing. Proficient in commissioning and project management software, such as Cx Alloy, Bluebeam, Procore, or similar platforms. Excellent problem-solving and analytical skills. Strong verbal and written communication skills. Ability to manage multiple priorities in a dynamic, fast-paced environment. Working Conditions: Regular travel to data center project sites. Ability to work in construction and industrial environments, including exposure to varying temperatures, noise levels, and confined spaces. May require extended hours during critical project phases. Compensation: $80,000 - $130,000, dependent on experience and location Health Benefits: Medical, Dental, Vision, LTD/STD, Life-AD&D Retirement: 401(k), discretionary Pension & Profit sharing, subject to Plan documents 15 days paid time off (prorated based on start date) and 8 holidays About Vertex Vertex Innovations, Inc. is a Colorado company founded in 2003 by Wayne and Erica Smith. "We could see where the future of communications was heading and wanted to take our passion and skill to build the nation's telecommunications infrastructure." Since those early days, Vertex Innovations has managed the buildout of today's wireless and fiber networks connecting millions of Americans and improving their daily lives. Our mission is to utilize our talents, experience, knowledge, and determination to create a connected society where everyone has the opportunity to foster meaningful connections, acquire knowledge, and make a positive impact on society. At Vertex, these Core Values created by our team serve as our guide in shaping today's connected society. Integrity - To move through the world with honesty and truth empowering our employees, clients and communities through our words and actions. Accountability - To take full ownership and responsibility in our roles as we serve our company, clients and communities. Commitment - To stand behind our word and our promises Respect - To embrace and honor the individuals, clients, and companies in their contribution to the work that we create together through our interactions, conversations and our way of being. Performance - To allow ourselves to be measured by our commitments and be accountable for every action to our employees, clients, and communities. VERTEX Innovations, Inc. 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.
    $36k-59k yearly est. 45d ago
  • Regulatory and Quality Assurance Specialist II (Remote)

    Us Fertility

    Remote quality systems specialist job

    US Fertility, the nation's largest partnership of physician-owned and physician-led top-tier fertility practices, a national network of premier IVF laboratories, are united under a shared mission to deliver the joy of parenthood through advanced reproductive medicine and innovative science. The Regulatory and Quality Assurance Special II is responsible for reviewing and implementing the applicable regulatory aspects and quality systems of the company while maintaining compliance with all regulatory agencies (FDA, State, Local and AABB). We have an immediate opening for a full-time Regulatory and Quality Assurance Special II to join our team. The schedule for this position is Monday-Friday 9am-5pm, and requires travel to Marlborough, MA once per month or as needed. How You'll Contribute: Implement, monitor, maintain, and improve the company's Quality System Implement, monitor, and maintain a document control system Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed Assure appropriate licensure is held and maintained by the company Facilitate quarterly meetings with medical directors to provide regulatory and quality updates Ensure medical directors complete all signoffs as required Assure compliance to international regulatory agencies Tracking and trending of laboratory, cryogenic, andrology, and deviation systems Maintain and improve deviation/non-conformance system Report events to regulatory bodies as applicable Assure training and competency of all staff Assist in preparation of regulatory strategies for changes to existing systems Participate in Continuing Education programs in related field Participate in planning and implementation of regulatory systems, document/change control and validation activities Establish and maintain good working relationships with department heads, regulatory authorities, and government agencies Implement and oversee audits for departments and systems to assure compliance to regulations and standards Track and ensure any identified deficiencies are rectified post an inspection/audit event Monthly and quarterly in person audits of quality and regulatory manuals and records Monthly and quarterly reports to leadership on Quality and Regulatory activities Perform other related duties as assigned by management What You'll Bring: Bachelor's degree or equivalent combination of training and experience Must have a high level of interpersonal skills to handle sensitive and confidential situations. Position continually requires demonstrated poise, tact, and diplomacy Must be able to interact and communicate professionally with individuals at all levels of the organization Clear and effective communication skills Proficiency in a variety of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, Excel, PowerPoint) Self-starter that adapts well to change in a fast-paced, dynamic environment Prior laboratory experience preferred Knowledge of industry, Federal and State regulations, licensing processes Strong aptitude for analyzing data, audit processes and reconciling records Demonstrated organizational skills and the ability to prioritize and coordinate multiple processes Excellent interpersonal skills and ability to work as part of a multi-disciplinary team and build and maintain effective working relationships. Excellent verbal & written communication skills Ability to work as part of a multi-disciplinary team Ability to organize and lead collaborative teams to facilitate quality projects (validations, corrective action plans, etc.) Occasional travel required (up to 25%) Able to adapt and thrive in the fast-paced, rapidly changing environment The successful candidate will have the ability to work well independently, as well as part of a team Excellent multi-tasking abilities More important than the best skills, however, is the right person. Employees who embrace our mission, vision, and core values are highly successful. What We Offer: Competitive pay + bonus Comprehensive training Medical, dental, vision, and 401(k) matching Generous paid time off and holidays Retirement plan Tuition assistance Ability to make an impact in the communities we serve At US Fertility, we promote and develop individual strengths in order to help staff grow personally and professionally. This is an ideal time to join our team! To learn more about our company and culture, visit here.
    $63k-94k yearly est. 24d ago
  • Quality Assurance Specialist/Engineer, Remote

    Nexis Builds

    Remote quality systems specialist job

    Ready to Build the Future? Apply Now! Join Nexis Builds and be part of a company that's redefining civil engineering with quality, technology, and innovation. Apply today and lets build something great together. What to expect: Competitive salary based on experience, ranging from $65,000 - $95,000 per year. Access to comprehensive health benefits, 401(k) employer match, and paid time off. Career development through mentorship, technical certifications, and leadership programs. About Nexis Builds At Nexis Builds, we are at the forefront of civil engineering, delivering large-scale infrastructure projects with precision, innovation, and sustainability. As a one of kind company, we are committed to building structures that last while continuously improving the way we work. Our team thrives on problem-solving, efficiency, and collaboration, ensuring that every project meets the highest standards of quality, safety, and client satisfaction. To maintain our commitment to excellence, we are seeking a Remote Quality Assurance (QA) Specialist/Engineer to oversee our project workflows, ensure regulatory compliance, and enhance quality processes from a remote setting. This role is integral to delivering high-quality engineering solutions across various projects. Your Role in Our Mission As a QA Specialist/Engineer, you will play a crucial role in ensuring that all engineering projects meet quality, compliance, and safety standards. You will work remotely to monitor performance, analyze trends, and drive continuous improvements, collaborating with onsite teams, engineers, and project managers to optimize processes. Key Responsibilities Monitor & Audit Project Workflows - Conduct remote quality audits on engineering workflows and construction documentation. - Identify deviations and work with teams to implement corrective actions. Data-Driven Quality Assurance - Track and analyze Service Level Agreements (SLAs) to ensure project deliverables meet expectations. - Develop real-time dashboards and trend reports to highlight quality performance and areas for improvement. - Work with AI-driven analytics tools to enhance predictive quality control. Process Improvement & Standardization - Collaborate with engineers and project managers to refine construction quality control plans. - Identify and eliminate inefficiencies in project execution. - Assist in developing and documenting tailored quality assurance plans for civil engineering projects. Regulatory & Compliance Oversight - Ensure all projects comply with local, national, and international regulations. - Conduct virtual inspections using remote monitoring tools, live-streaming, and drone data analytics. - Support field teams in maintaining OSHA, EPA, and building code compliance. Training & Continuous Learning - Train project teams on quality standards, best practices, and compliance protocols. - Lead virtual training sessions to enhance quality awareness across different departments. - Participate in special projects and process improvement initiatives. What Were Looking For Must-Have Skills & Experience: Bachelors degree in Civil Engineering, Quality Management, Construction Management, or a related field. 3+ years of experience in a QA/QC role within the construction or civil engineering industry. Strong understanding of quality control procedures, engineering best practices, and industry standards ). Experience using data visualization tools (Excel, Power BI, Tableau) to generate reports. Excellent analytical and problem-solving skills to detect and resolve quality issues. Proficiency in remote collaboration tools (Microsoft Teams, Asana, Trello, or similar). Strong communication and interpersonal skills for interacting with cross-functional teams. Ability to multitask and prioritize work in a fast-paced engineering environment. Nice-to-Have Skills: Experience with BIM software (Revit, AutoCAD) for virtual quality inspections. Knowledge of Machine Learning & AI applications in predictive quality control. Familiarity with cloud-based project management systems (Procore, Primavera, Bluebeam). Certifications such as Certified Quality Engineer (CQE), Six Sigma, or PMP. What You Can Expect in This Role Remote-first position with occasional onsite visits if required. Full-time (40 hours per week) role with flexible work hours. Competitive salary based on experience, ranging from $65,000 - $95,000 per year. Access to comprehensive health benefits, 401(k) employer match, and paid time off. Career development through mentorship, technical certifications, and leadership programs. Opportunity to be part of a high-impact, innovation-driven engineering team. At Nexis Builds, we believe in growth, flexibility, and innovation. We are committed to fostering a diverse, inclusive, and equitable workplace where everyone has the opportunity to thrive. Ready to Build the Future? Apply Now!
    $65k-95k yearly 60d+ ago
  • ASSURE Patient Specialist - San Antonio, TX (Per Diem/On Call)

    Kestra Medical Technologies

    Remote quality systems specialist job

    The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra's solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life. The ASSURE Patient Specialist (APS) conducts patient fitting activities in support of the sales organization and the team of Regional Clinical Advisors (RCA). The APS will serve as the local patient care representative to provide effective and efficient patient fittings. This is a paid per fitting position. ESSENTIAL DUTIES Act as a contractor ASSURE Patient Specialist (APS) to fit and train local patients with a wearable defibrillator via training assignments dispatched from corporate headquarters. The APS will be trained and Certified as an ASSURE Patient Specialist by Kestra. Ability to provide instruction and instill confidence in Assure patients with demonstrated patient care skills Willingness to contact prescribers, caregivers and patients to schedule services Ability to accept an assignment that could include daytime, evening, and weekend hours Travel to hospitals, patient's homes and other healthcare facilities to provide fitting services Measure the patient to determine the correct garment size Review and transmit essential paperwork with the patient to receive the Assure garment and services Manage inventory of the Assure system kits, garments, and electronic equipment used in fittings Flexibility of work schedule and competitive pay provided Adhere to Pledge of Confidentiality Information regarding a patient of this company shall not be released to any source outside of this company without the signed permission of the patient. Furthermore, information will only be released internally on a need-to-know basis. All Team Members will not discuss patient cases outside the office or with anyone not employed by this company unless they are directly involved with the patient's case. COMPETENCIES Passion: Contagious excitement about the company - sense of urgency. Commitment to continuous improvement. Integrity: Commitment, accountability, and dedication to the highest ethical standards. Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or service. Action/Results: High energy, decisive planning, timely execution. Innovation: Generation of new ideas from original thinking. Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind. Emotional Intelligence: Recognizes, understands, manages one's own emotions and is able to influence others. A critical skill for pressure situations. Highly organized, service and detail orientated Passionate about the heart-failure space and a strong desire to make a difference Strong interpersonal skills with communicating and assisting clinicians with providing care for patients. Interest and desire for life-long learning to continuously improve over time. Requirements Education/Experience Required: 1 year in a paid patient care experience (not as a family care giver) Clinical or engineering background which may include but is not limited to nurses, cardiac device sales representatives, clinical engineers, catheterization lab technicians, physician assistants, or ECG technicians. Disclosure of personal NPI number (if applicable) Completion of background check. Florida and Ohio must complete a level 2 screening paid for by Kestra. Willingness to pay an annual DME fee which is deducted from the completed work order Ability to pay for vendor credentialing upfront during a 90-day probationary period Experience in patient and/or clinician education Valid driver's license in state of residence with a good driving record Ability to consistently work remotely Disclosures are required for any potential relationships and referral sources Must be able to achieve credentialing for hospital system entry including, but not limited to: Documentation of vaccination and immunization status Pass background check Pass drug screening testing Review and agree to hospital policies and procedures Completion of online courses, i.e., HIPAA, Bloodborne Pathogens and Electrical/Fire Safety Preferred: Knowledge of MS Office, Excel, PowerPoint, MS Teams Direct cardiac patient care experience - RN, RT, CVIS, Paramedic, CRM WORK ENVIRONMENT Variable conditions during travel Minimal noise volume typical to an office or hospital environment Possible environmental exposure to infectious disease (hospital and clinic settings) Extended hours when needed Drug-free PHYSICAL DEMANDS Ability to travel by car Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage Frequent stationary position, often standing or sitting for prolonged periods of time Frequent computer use Frequent phone and other business machine use Occasional bending and stooping Ability to lift up to 40 pounds unassisted, at times from in and out of vehicle TRAVEL Frequent travel by car in agreed upon geography OTHER DUTIES: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
    $46k-81k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Specialist II, CMO

    Harrow, Inc.

    Remote quality systems specialist job

    Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us. Who is Harrow? Harrow (Nasdaq: HROW) is a leading North American ophthalmic-focused pharmaceutical company. Harrow is an incredible entrepreneurial company - where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow's values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world - providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need . We encourage you to learn more about Harrow and its unique culture to see if you're the right person to help contribute as we build a truly exceptional company, one we are all so proud of! Harrow's ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including: An expanding Posterior Portfolio including IHEEZO and TRIESENCE A broad Dry Eye Disease product line, led by VEVYE and bolstered by well-known adjacent ocular surface disease products such as FLAREX and TOBRADEX ST A Specialty Anterior Segment product line, which includes various high-need and utility products such as ILEVRO , NEVANAC , and VERKAZIA Job Summary The QA Specialist II is responsible for overseeing and supporting external manufacturing operations of our global CMO Partners. The QA Specialist II position is an individual contributor role responsible for providing mid-level QA oversight of CMO operations in accordance with business agreements and international regulatory and industry standards. Secondarily, this role provides mid-level administrative support and basic general peer-to-peer guidance to junior team members to the internal quality department. Duties also include administrative tasks and projects for both the management and for members of the quality department. Core Responsibilities Partner closely with Harrow Eye's External Manufacturing, Supply Chain and Regulatory Affairs team to ensure consistent and collaborative communication to external manufacturing partners Work cross functionally to provide a single point of contact for QA technical support to internal team and external manufacturing partners Effectively communicate issues, risks, and proposed solutions within the organization Assist with, conduct and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation. Provide communication, support, and guidance to manufacturing partners and within the QA CMO team Facilitates implementation of policies and procedures for CMO compliance, including development of quality agreements. Quality business processes and product disposition in accordance with team derived strategy and business realities. Perform batch record review and lot disposition activities as required Support internal and external audits as needed Create and revise standard operating procedures as needed Coach and mentor junior team members on a peer-to-peer level basis. Other duties as assigned. Qualifications & Requirements A minimum of BS/BA in a scientific disciplinary. 5+ years related industry experience with a minimum of 3 years' experience in quality assurance, quality control and compliance. Proven track record on investigations, deviations, change controls, product quality complaints and supplier qualification. Strong organizational skills, including ability to follow assignments through to completion. Knowledge of relevant regulations and guidance documents Strong decision-making capability and ability to ask compelling questions and to think strategically and understand global impact of decision Excellent verbal and written communication skills Detail-oriented with skills in problem solving and solid decision-making abilities Experience with working autonomously with proven ability to meet deadlines Proficient in the use of standard Microsoft Office software products, including Outlook, Word, and Excel required.
    $50k-79k yearly est. Auto-Apply 20d ago
  • EN/VR QA & Training Specialist

    Cybermedia Technologies

    Remote quality systems specialist job

    CTEC is a leading technology firm that provides modernization, digital transformation, and application development services to the U.S. Federal Government. Headquartered in McLean, VA, CTEC has over 300 team members working on mission-critical systems and projects for agencies such as the Department of Homeland Security, Internal Revenue Service, and the Office of Personnel Management. The work we do effects millions of U.S. citizens daily as they interact with the systems we build. Our best-in-class commercial solutions, modified for our customers' bespoke mission requirements, are enabling this future every day. The Company has experienced rapid growth over the past 3 years and recently received a strategic investment from Main Street Capital Corporation (NYSE: MAIN). In addition to our recent growth in Federal Civilian agencies, we are seeking to expand our capabilities in cloud development and footprint in national-security focused agencies within the Department of Defense and U.S. Intelligence Community. We are seeking to hire an EN/VR QA & Training Specialist to our team! Join Us in Empowering Lives Through SSA's Employment Support Initiatives Are you passionate about making a meaningful difference in people's lives? The Social Security Administration (SSA) is committed to helping individuals with disabilities achieve greater independence through employment. By joining our team, you'll play a vital role in supporting this impactful mission-helping people unlock their potential, build confidence, and create brighter futures. If you're driven by purpose and inspired by the chance to make a lasting impact, we invite you to be part of a program that changes lives every day. The EN/VR QA & Training Specialist leads advanced quality assurance and training activities for the EN/VR Help Desk. This position performs in-depth performance analysis, conducts comprehensive call monitoring, and delivers individualized coaching and feedback to Help Desk staff to drive ongoing quality improvement and compliance. The Specialist develops and updates training programs, oversees onboarding and continuing education initiatives, and works closely with management to identify trends and recommend process enhancements. Responsibilities include detailed documentation of findings, analysis of key performance metrics, and facilitating workshops or group training sessions. Duties and Responsibilities: • Lead advanced call monitoring and quality assurance for EN/VR Help Desk operations. • Analyze performance data and key metrics to identify trends, risks, and opportunities for improvement. • Provide detailed coaching and actionable feedback to individual staff and teams. • Develop, deliver, and update training programs, materials, and job aids. • Facilitate onboarding for new Help Desk staff and ongoing development for existing team members. • Document and report on quality assurance findings, compliance issues, and training effectiveness. • Collaborate with management to implement process improvements and best practices. Requirements: • Bachelor's degree with 2-4 years of relevant experience, or high school diploma/GED with 8-10 years related experience. • In-depth experience conducting quality assurance, performance analysis, and staff coaching in customer service or help desk environments. • Strong analytical skills and proficiency with call monitoring and reporting tools. • Demonstrated ability to develop training content and deliver effective training sessions. • Excellent written and verbal communication and interpersonal skills. • Leadership ability and proven track record of driving quality improvements. • Thorough understanding of program compliance and service standards. Must be able to obtain and maintain a SSA Public Trust Clearance If you are looking for a fun and challenging environment with talented, motivated people to work with, CTEC is the right place for you. In addition to employee salary, we offer an array of employee benefits including: Paid vacation & Sick leave Health insurance coverage Career training Performance bonus programs 401K contribution & Employer Match 11 Federal Holidays
    $50k-79k yearly est. Auto-Apply 60d+ ago
  • QA/Compliance Specialist - Wellness and Consumer Brands

    Bioptimizers

    Remote quality systems specialist job

    At BiOptimizers, our mission is to move people from baseline health to peak biological performance. Rooted in scientific rigor, we design supplements and experiences that empower individuals to excel. Our remote-first team collaborates cross-functionally, blending innovation with results to magnify human potential. The QA/Compliance Specialist plays a key role in ensuring that all products, raw materials, and manufacturing partners meet the company's quality and regulatory standards. This position is responsible for reviewing and maintaining quality documentation, approving and monitoring suppliers, and ensuring compliance with the Dietary Supplement Health and Education Act (DSHEA), 21 CFR Part 111/117, and related FDA and FTC regulations Key Responsibilities Quality Documentation & Product Compliance Review Certificates of Analysis (CoAs), master manufacturing records (MMRs), and batch production records (BPRs) from contract manufacturers for accuracy and completeness. Verify that all documentation complies with internal specifications, label claims, and DSHEA requirements for identity, purity, strength, and composition. Maintain comprehensive document control systems, including version management, retention, and archival of GMP documentation. Review finished product labels and marketing claims for DSHEA and FDA compliance. Support product release processes by ensuring that each lot meets established quality standards before distribution. Supplier Qualification & Oversight Lead or support supplier qualification, approval, and requalification activities per company procedures and DSHEA/GMP standards. Evaluate supplier documentation, including GMP certifications, audit reports, questionnaires, and ingredient specifications. Maintain the Approved Supplier List (ASL) and track supplier performance, deviations, and corrective actions. Support audits of contract manufacturers and ingredient suppliers to verify compliance with GMP and DSHEA. Regulatory & DSHEA Compliance Ensure all dietary supplement products are manufactured, labeled, and marketed in compliance with DSHEA, FDA, and FTC regulations. Maintain awareness of regulatory updates related to dietary supplements and communicate implications to internal stakeholders. Assist in managing adverse event reporting, product recalls, and regulatory inspections in alignment with DSHEA and company policy. Support development, review, and continuous improvement of SOPs, CAPAs, and change control processes. Partner with cross-functional teams to ensure product claims are substantiated and compliant with DSHEA structure/function requirements. Continuous Improvement & Quality Culture Identify gaps in quality systems and recommend enhancements to strengthen compliance and operational efficiency. Support internal training programs on DSHEA, GMP, and quality standards to reinforce compliance culture across teams. Participate in internal audits and assist in readiness for FDA, NSF, or third-party inspections. Education: Bachelor's degree in Life Sciences, Food Science, Chemistry, Biology, or related field required. Experience: 3-5 years of QA/compliance experience in the dietary supplement, nutraceutical, or pharmaceutical industry. Demonstrated understanding of DSHEA, FDA cGMP (21 CFR Part 111/117), and related regulatory requirements. Experience working with contract manufacturers and suppliers in a quality or compliance capacity. Strong attention to detail and organizational accuracy. Excellent written and verbal communication skills. Proficiency with document management systems and Microsoft Office Suite. Ability to interpret and apply DSHEA, GMP, and labeling regulations in practical business settings. Preferred Qualifications Experience with regulatory submissions, structure/function claim substantiation, and label compliance review. Familiarity with NSF, UL, Non-GMO, and Organic certification standards. Experience using electronic QMS or document control software (e.g., MasterControl, Greenlight Guru, TrackWise). Knowledge of international supplement regulations (e.g., Health Canada, EU). Work Location This is a fully remote position. BiOptimizers has a globally distributed team and supports flexible work arrangements across time zones. Company Hours & Collaboration With team members across many countries and time zone differences of up to 16 hours, we've established a standard collaboration window from 9:00 AM - 5:00 PM EST. This is not a required work schedule, but a shared time frame for meetings and team syncs. At BiOptimizers, we support flexibility - team members are encouraged to work the hours that best suit them, as long as they: Attend required meetings Communicate effectively across time zones Deliver work by agreed-upon deadlines Equal Opportunity Statement BiOptimizers is committed to diversity and inclusion and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other basis protected by applicable law.
    $50k-79k yearly est. Auto-Apply 20d ago
  • QA Compliance Specialist

    Lancesoft 4.5company rating

    Quality systems specialist job in Columbus, OH

    The QA Compliance Specialist position exists to support the execution of quality & regulatory functions in the organization to ensure compliance with the AV-SH quality/business systems to applicable regulations, standards and corporate policies. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Support external audit activities (FDA, FDB, ISO registrar audits etc.). Audit areas of client s Vascular Quality System. Support administration of Quality System processes (CAPAs, Internal Audits etc.). Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports. Track and trend compliance activities on a periodic basis. This may include CAPA & IACA metrics etc. Generate compliance metrics for Management Reviews. Assist the organization to receive timely feedback on open corrective actions. Participate in cross divisional activities to integrate quality system information. Conduct review and update Quality System procedures as necessary. Assist in developing & conducting Quality System training as necessary. File Quality Records (audit reports, IACAs, CAPAs etc.). Ensure that all responsibilities are carried out in compliance with governing regulations and standards. Other duties as assigned. Education: Bachelor Degree or equivalent plus 4 + years of related work experience or equivalent combination.
    $69k-90k yearly est. 43d ago

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