Quality assurance manager jobs in Madison, WI - 114 jobs

Endsulin (***************** is a cutting-edge pre-clinical gene therapy startup biotechnology company in Madison, WI. Our primary goal is to develop a gene therapy to treat diabetes for the millions of people suffering from diabetes worldwide. Endsulin is located at University Research Park in the Forward Biolabs co-working biotechnology incubator. Job Description The Director of Quality Assurance and Regulatory Affairs (QA/RA), you will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality products enter emerging, regulated, and clinical global markets. You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company. Continuous improvement and ad-hoc issue resolution to drive improvement of quality operations, at the lowest costs and in full compliance of all relevant regulations and standards. This role is ideally suited to a candidate who is self-motivated and excited by an opportunity to rise to frequent and diverse challenges. Qualifications Duties/Responsibilities • Responsible for development, implementation, maintenance, and overall success of the company's quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality. • Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy. • Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. • Ensure that regulated processes and systems are always inspection ready. • Oversee the performance of internal and external audits. • Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. • Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RA functions • Serve as person responsible for regulatory compliance (PRRC). • Other duties as assigned. Skills & Abilities • Extensive experience hosting regulatory inspections and interacting with regulators • Strong understanding of global registration requirements and demonstrated track record of successful market access. • Experience with computer software validation (CSV) and implementation for QMS and ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution • General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices • Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management • Proven ability to create culture of accountability and ownership • Proven track record with establishing and maintaining strong internal and external partnerships. • Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. • Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. • Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. • Highly independent and self-motivated and integrates well within a team. Physical Demands • Ability to remain seated for long periods of time while working on computer or referring to documents. • Must have manual dexterity to operate computer keyboard and standard office equipment. • Positions: Standing, walking, sitting, stooping. • Ability to travel. Education • Bachelor's degree required in a science, engineering field or related discipline. • MBA is a plus Experience • 10 years of QMS experience and demonstrated leadership experience. • Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT); CFR's parts 210 &211. Additional Information All your information will be kept confidential according to EEO guidelines.

Give hope. Give health. Make your mark in the fight against cancer. At Accuray, we make a direct and powerful impact on the lives of cancer patients every day - helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer - helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world. Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives. Job Description Do you have a passion for quality and a drive to ensure suppliers meet top-tier standards? Accuray is always on the lookout for skilled Supplier Quality Engineers to join our team. If there isn't a current opening that matches your skill set, we encourage you to apply through this General Interest Pipeline. By doing so, you'll be considered for future Supplier Quality opportunities that align with your experience and career goals. WHY WORK FOR ACCURAY? At Accuray, we give hope through innovation. Our goal is to develop cutting-edge radiation therapy solutions that help people diagnosed with cancer get back to living their lives, faster-and every role contributes to this purpose. We're a team of passionate problem-solvers driven by the desire to make an impact. You'll work in a collaborative, inclusive environment where your ideas-and your growth-matters. We offer competitive benefits, flexible work options, and the chance to shape the future of healthcare with AI and advanced technologies. Join us-and help give patients hope for more time to make memories that matter. About The Role and What we Look For Supplier Quality Engineer: The supplier quality engineer is a member of the quality assurance team who plans and performs activities related to the selection, monitoring, and control of purchased materials and suppliers. They work cross-functionally with engineering, procurement, manufacturing, service, and other quality teams to support all phases of the product lifecycle from initial product development through customer support. Successful candidates for this role have a high degree of resourcefulness by delivering timely and effective results in a dynamic and fast-paced environment with a high degree of autonomy. If you have experience in Supplier Quality, we encourage you to apply to this General Interest Pipeline. This allows us to consider you for future openings as they become available. To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship. EEO Statement At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top - and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin - including individuals with disabilities and veterans.

Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on **Director of Quality** to lead product and supplier quality assurance efforts within our **Life Sciences business unit** , which includes the **Datavant Connect** and **Aetion Evidence Platform** . These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is essential to operationalizing Datavant's **Quality Management System (QMS)** across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments. **What You Will Do** + Lead the development and continuous improvement of Datavant's QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance. + Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring. + Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation. + Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring. + Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives. + Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners). + Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP. + Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation. + Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality program in external communications, including client onboarding, RFIs, and quality-related escalations. **What You Need to Succeed** + 8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations. + Strong working knowledge of relevant regulations and frameworks, including **FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** , and **GDPR** . + Proven leadership in scaling and operationalizing a **QMS in a SaaS, RWD, or GxP context** . + Experience managing and mentoring cross-functional teams. + Demonstrated success overseeing **validation, supplier oversight, internal audits, and CAPA management** . + Deep understanding of **data governance, privacy, and security** best practices. + Experience interacting with external auditors, customer compliance teams, or regulatory agencies. + Strong communication skills-capable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders. **What Helps You Stand Out** + Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions. + Background working in or with tokenization, health data linkage, or privacy-enhancing technologies. + Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams. + Training or certification in Six Sigma, ISO Auditing, or software validation methodologies. + Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl). + Experience contributing to industry working groups on quality, data integrity, or health data compliance. \#LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is: $165,000-$230,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here (************************************************** . Know Your Rights (*********************************************************************** , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, (************************************************************** Id=**********48790029&layout Id=**********48795462) by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here (******************************************************************************************************* . Requests for reasonable accommodations will be reviewed on a case-by-case basis. For more information about how we collect and use your data, please review our Privacy Policy (**************************************** .

Are you looking to join a dynamic team that provides its people with the tools to be successfull and opportunities to grow? Universal Logistics is a leading provider of customized transportation and logistics solutions, offering a comprehensive suite of services including transportation, value-added, intermodal, and specialized services utilized throughout entire supply chains. Universal has immediate career opportunities in your area. Apply today to become part of the Universal team! Universal Logistics Holdings, Inc. is a leading asset-light provider of customized transportation and logistics solutions. We provide our customers with supply chain solutions that can be scaled to meet your changing demands and volumes. We offer a comprehensive suite of services including transportation, value-added, intermodal and specialized services that can be utilized throughout your entire supply chain. Currently, we are seeking Warehouse Quality Manager candidates for a position based out of our operation in Madison, WI. where we support manufacturer in the area. Job Responsibilities: -Process engineering and validation -Developing and maintaining Quality Management System manual, procedures and standard work instructions -Identifying non-conformances with root cause corrective actions to mitigate occurrences and risk -Implementing quality objectives (KPI) across all departments for monitoring and measuring performance -KPI trend analysis -Forecasting operational capacity across all departments -Scheduling Layered Process Audits (LPA) and Process Failure Modes and Effects Analysis (PFMEA) -Inventory management and reconciliation -Standardized training procedure and developing associates -Continuous improvement projects with focus on lean and six sigma principles (PDCA, DMAIC & DMADV) -Developing and generating report card for supplier compliance The ideal candidate will possess knowledge and/or experience in the following areas: -Experience in ISO: 9001, 2015 International Standard Certification -Experience in developing and implementing a Quality Management System -Lean and six sigma principles (PDCA, DMAIC & DMADV) -Understanding of the importance of PEAR in regard to Quality Management System -Experience in managing third-party audits to ensure compliance with regulatory standards Other requirements include: · Bachelor's Degree preferred · Highly organized with a strong attention to detail · Good oral and written communication skills · Eager to learn · Ability to make quick decisions · Good work ethics · Ability to meet deadlines This position offers a competitive wage and benefits package, as well as offering upward mobility within the company. If you are an energetic, self-motivated individual with the drive to become part of a growing organization, do not hesitate, respond today! Look us up on the web at: **************************

Are you ready for a new beginning? We need your talent, knowledge and dedication to better our world with biology. Our purpose points the way In Novonesis, we know that solutions rooted in biology can help solve humanity's biggest challenges. Since we began more than a century ago, this has been our guide. It's how we've gotten so far. And it's how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless. We're here to better our world with biology. Join us as the Site Quality Manager - Food Cultures and Dietary Ingredients As the Site Quality Manager, you'll oversee quality operations for food cultures and dietary ingredient production. You'll play a pivotal role in aligning product usage requirements with practical, compliant, and efficient manufacturing processes. This is your opportunity to lead across business units, influence key stakeholders, and ensure exceptional quality standards from shop floor to boardroom. Are you a passionate quality professional with deep knowledge of 21 CFR 117? Can you bridge the gap between product requirements and manufacturing excellence? If so, we want YOU to be the next Quality Leader at our Wisconsin-based food manufacturing facility! In this role you'll make an impact by: Driving compliance with 21 CFR 117 and other FDA regulations. Translating complex product requirements into actionable and achievable manufacturing standards. Collaborating across departments to align quality goals with broader business objectives. Leading audits, inspections, and quality system improvements as the go-to resource. Inspiring and guiding teams to achieve sustainable, high-performance results. To succeed you must hold: 10+ years of experience in food, feed, or dietary ingredient manufacturing. 5+ years of people leadership experience, including mentoring, developing, and empowering teams to achieve high performance and continuous improvement. Expertise in 21 CFR 117 and GMP principles. Proven ability to lead cross-functional teams and drive quality excellence. Strong communication skills to influence everyone-from the shop floor to executives. A track record of turning regulatory requirements into practical, effective solutions. Location: Madison, WI (On-Site) Application deadline: January 31, 2026 Expected salary range: $130,000 - $150,000 Benefits you will enjoy: 401(k) with up to a 9% company contribution Minimum of 3 weeks of vacation plus 12 holidays and 2 weeks of Wellness Time Health, Dental, Vision & Life insurance Healthcare savings account option Employee assistance program Parental leave Tuition reimbursement All benefits begin on your first day Could our purpose be yours? Then apply today! At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV. Novonesis is dedicated to fostering a unique community by embracing and respecting differences. We make all employment decisions based on business needs, ensuring that every individual can thrive, regardless of identity or background such as ethnicity, religion, gender, sexual orientation, age, disability, or veteran status. Want to learn more? Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com Not the right fit for you? Even if this job isn't the right fit for you, perhaps you know someone who might find it interesting. If so, please feel free to share the job link and encourage them to apply. Thank you for your referral! Please check out our other open positions. The right fit for you could just be a few clicks away. Stay alert: Avoid recruitment scams At Novonesis, we are committed to maintaining a safe and transparent recruitment process. Please be aware of potential scams targeting job seekers and take note of the following: Novonesis will never ask for sensitive personal information, such as bank account details, Social Security numbers, or passwords, at any stage of the hiring process. Novonesis does not make employment offers without conducting interviews with candidates. If you receive suspicious communication claiming to be from Novonesis, please do not share any personal or financial information. We encourage you to verify the legitimacy of the message by contacting us directly through our official channels.

Managing, analyzing, integrating and improving business development capabilities. Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities * Executes against the Quality & Regulatory Business Development Process. This includes scheduling, preparation, execution, reporting, and follow-up activities associated with Business Development activities; identification and communication of high-risk issues; reporting compliance concerns and recommended improvements to business leadership; developing and ensuring strategy is executed to current industry practices and regulatory expectations. * Standardization of processes, tools, and performance management system. * Requires ability to lead functional teams or projects with indirect resources and medium to high risk and/or complexity. Communicates difficult concepts and influences others' options on topics. May guide others to consider a different point of view. * Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation. * Impacts the team's ability to achieve service, quality, and timeliness of objectives. Work is subject to GE HealthCare policy objectives. * Regularly advises Quality and Regulatory management in business development. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required. * Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision. * Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results. Required Qualifications * Master's Degree and a minimum of 7 years' experience in the medical device or pharmaceutical industry; or Bachelor's Degree and a minimum of 9 years' experience in the medical device or pharmaceutical industry; or will consider a High School Diploma and a minimum of 13 years' of progressive responsibility in the medical device or pharmaceutical industry. * Minimum of 5 years' Experience driving Global programs to resolve quality compliance issues (directly). * Experience with Pharma QMS requirements and regulatory requirements including but not limited to FDA 21 CFR Part 211 & 212, Eudralex and PICS. Desired Characteristics * Demonstrated ability to lead programs /projects. Ability to document, plan, market, and execute programs. Established project management skills. * Demonstrated ability to analyze and resolve problems. * ASQ Certification (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt). * Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely. * Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner. * Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions. * Strong oral and written communication skills in English. * Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others. * Ability to travel domestically and internationally up to 20%. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. #LI-MC2 We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $142,400.00-$213,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: Yes

Why work for Manitou Group? Manitou is purposefully committed to you, its people. Based on a “One United Team” focus, we internationally cultivate our purpose-driven and agile work environment. As an equal opportunity employer, we cultivate, build and elevate our more than 6000 employees and their diversity across more than 30 countries we operate in. There are 6 main plants with locations in France, the USA, India, Italy and more than 30 subsidiaries all around the world. Are you looking for a new opportunity? Join us to be part of our continuous success. GENERAL ACCOUNTABILITY: The Quality Manager will have responsibility for planning, implementing and administering policies and activities to (1) ensure compliance with standards, rules and regulations, and (2) prevent warranty claims. The Quality Manager position will report to the Plant Manager. DUTIES & RESPONSIBILITIES: Develop, implement, communicate and maintain a quality system for the facility that meets or exceeds customer requirements to include specific quality goals, objectives, policies, procedures, and audit systems for the business. Set the direction of quality assurance by effectively leading cross-functional teams, analyzing root cause, developing corrective action programs, and employing formal problem solving methodologies. Work with other departments to ingrain these principles and methods throughout the organization. Establish methods and standards to monitor quality performance. Work with staff to develop and implement standard work procedures and quality control checks throughout the manufacturing process. Identify any trends and communicate the results to drive continuous improvement within the facility. Participate in new product reviews to help design quality into the product and processes. Develop internal and supplier quality metrics, trend analysis, continuous improvement plans, and statistical reports that will support the procurement process and establish a level of supplier compliance with quality and assurance. Continually reduce variability within existing processes by utilizing problem solving techniques. Establish a strong customer feedback mechanism using corrective action reports. EXPERIENCE: Minimum 5 years prior experience in quality assurance for a commercial product manufacturer. Direct experience with managing quality systems for a highly engineered product portfolio. Experience in quality system audits. EXPERTISE: Knowledge of the principles of quality assurance, ISO/TS, TQM, Six Sigma, and LEAN manufacturing. Sound administrative skills and well-developed management skills. Proven ability to mentor and motivate personnel in order to balance staffing strength with profitability and growth. Ability to build positive partnerships and work collaboratively with cross-functional business teams. Excellent communication skills, written and verbal skills. EDUCATION: Bachelor's Degree in engineering or applied science field required. Equivalent combination of experience and education will be considered. INTERNAL & EXTERNAL CONNECTIONS: Internal: Sourcing, Purchasing, Quality, and Production Teams External: Interaction would be suppliers related to the product family you are assigned. What does MANITOU Group offer? Base Salary Range between $96,000 - $130,000 per year, plus a potential annual bonus based on performance metrics Actual pay determined by experience level, skills, qualifications & work location This position is located in Madison, SD onsite. Travel Requirements - Travel is limited but may visit our Yankton facility periodically In addition to an inclusive compensation package, we offer a comprehensive benefits program including Medical/Dental/Vision, a matching 401k, tuition reimbursement, volunteer program, wellness activities, employee and family activities throughout the year and so much more! Applicants must be authorized to work in the United States. Manitou Group is an Equal Opportunity Employer. Qualified applicants are considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, or disability status. What is MANITOU Group? To learn more about Manitou Group, click here

Job ID 45321 Date 17 December 2025 Job Family * Quality Type of contract * Permanent * Permanent Why work for Manitou Group? Manitou is purposefully committed to you, its people. Based on a "One United Team" focus, we internationally cultivate our purpose-driven and agile work environment. As an equal opportunity employer, we cultivate, build and elevate our more than 6000 employees and their diversity across more than 30 countries we operate in. There are 6 main plants with locations in France, the USA, India, Italy and more than 30 subsidiaries all around the world. Are you looking for a new opportunity? Join us to be part of our continuous success. GENERAL ACCOUNTABILITY: The Quality Manager will have responsibility for planning, implementing and administering policies and activities to (1) ensure compliance with standards, rules and regulations, and (2) prevent warranty claims. The Quality Manager position will report to the Plant Manager. DUTIES & RESPONSIBILITIES: * Develop, implement, communicate and maintain a quality system for the facility that meets or exceeds customer requirements to include specific quality goals, objectives, policies, procedures, and audit systems for the business. * Set the direction of quality assurance by effectively leading cross-functional teams, analyzing root cause, developing corrective action programs, and employing formal problem solving methodologies. Work with other departments to ingrain these principles and methods throughout the organization. * Establish methods and standards to monitor quality performance. Work with staff to develop and implement standard work procedures and quality control checks throughout the manufacturing process. Identify any trends and communicate the results to drive continuous improvement within the facility. * Participate in new product reviews to help design quality into the product and processes. * Develop internal and supplier quality metrics, trend analysis, continuous improvement plans, and statistical reports that will support the procurement process and establish a level of supplier compliance with quality and assurance. * Continually reduce variability within existing processes by utilizing problem solving techniques. * Establish a strong customer feedback mechanism using corrective action reports. EXPERIENCE: * Minimum 5 years prior experience in quality assurance for a commercial product manufacturer. Direct experience with managing quality systems for a highly engineered product portfolio. * Experience in quality system audits. EXPERTISE: * Knowledge of the principles of quality assurance, ISO/TS, TQM, Six Sigma, and LEAN manufacturing. * Sound administrative skills and well-developed management skills. * Proven ability to mentor and motivate personnel in order to balance staffing strength with profitability and growth. * Ability to build positive partnerships and work collaboratively with cross-functional business teams. * Excellent communication skills, written and verbal skills. EDUCATION: * Bachelor's Degree in engineering or applied science field required. Equivalent combination of experience and education will be considered. INTERNAL & EXTERNAL CONNECTIONS: * Internal: Sourcing, Purchasing, Quality, and Production Teams * External: Interaction would be suppliers related to the product family you are assigned. What does MANITOU Group offer? * Base Salary Range between $96,000 - $130,000 per year, plus a potential annual bonus based on performance metrics * Actual pay determined by experience level, skills, qualifications & work location * This position is located in Madison, SD onsite. * Travel Requirements - Travel is limited but may visit our Yankton facility periodically * In addition to an inclusive compensation package, we offer a comprehensive benefits program including Medical/Dental/Vision, a matching 401k, tuition reimbursement, volunteer program, wellness activities, employee and family activities throughout the year and so much more! * Applicants must be authorized to work in the United States. * Manitou Group is an Equal Opportunity Employer. Qualified applicants are considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, or disability status. What is MANITOU Group? To learn more about Manitou Group, click here Apply Link copied Share Location(s) * United States - Madison To view this interactive map, you must consent to the Google Maps service. Allow and display the map

Quality Manager - Assurance Location: SVA Offices (On-site preferred; regular travel required) - includes Madison, WI; Brookfield, WI; Colorado Springs, CO Reports To: Director of Quality Management At SVA, we believe in Serving People Better-our clients, our communities, and each other. The Quality Manager - Assurance plays a key role in advancing the firm's assurance practice by supporting audit quality, consistency, and compliance across the firm. This position supports the Director of Quality Management by performing Engagement Quality Reviews (EQRs)-with a strong emphasis on Government Auditing Standards (HUD, USDA-RD, and Single Audits)-and by contributing to firm-wide initiatives that strengthen assurance quality, efficiency, and technical excellence. Essential Functions Perform Engagement Quality Reviews for assurance engagements, focusing on audits under GAGAS / Yellow Book standards. Assist with the implementation and ongoing maintenance of the firm's Quality Management Policies and Procedures (QMPP). Monitor new accounting and auditing standards and support firm-wide implementation efforts. Maintain and enhance the firm's Assurance Resources, including practice aids, technical guidance, and intranet/Teams sites. Provide technical research and guidance on complex accounting and auditing matters. Support assurance quality initiatives and efficiency-improvement projects. Participate in internal training efforts, including CPE programs and the annual A&A Update. Assist with maintaining compliance with GAGAS / Yellow Book requirements. Serve as a Qualified Reviewer or Assurance Manager on engagements, as needed. Qualifications Bachelor's degree in Accounting or related field required; Master's preferred 7+ years of public accounting audit experience Experience with Government Auditing Standards and Single Audits preferred Active CPA license required Skills & Attributes Strong expertise in audit documentation review and quality standards Excellent written, verbal, and interpersonal communication skills Ability to research and clearly communicate complex technical issues Highly motivated, detail-oriented, and capable of working independently Strong ethical standards and professional judgment Ability to manage deadlines and perform well under pressure Located near and willing to travel regularly to SVA offices (on-site work preferred) Demonstrates SVA's core value of Serve People Better and aligns with the SVA DNA Fundamentals

The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Manager, Data Quality, is responsible for overseeing the full data management lifecycle and operational workflow of Company Entity Management (CEM) for company and contact data within Dodge Construction Network's (Dodge) master data ecosystem. This role leads both onshore and offshore teams to ensure the accuracy, completeness, and standardization of company entities that power Dodge's products, customer experiences, and analytics. The Manager will define and execute the end-to-end operating model for CEM including the development of Standard Operating Procedures (SOPs), establishing KPIs, designing quality and governance frameworks, and defining requirements for automation and human-in-the-loop workflows. This role drives continuous improvement by refining processes, enhancing data sourcing and enrichment, evaluating automation outputs, and collaborating closely with cross-functional partners across Product, Engineering, and Operations. This leader must bring strong people management and project management skills, an analytical mindset, and have experience working in scalable data operations environments. This is a full-time position and reports directly to the Director of Data Acquisition. **_Preferred Location_** + This is a remote, home-office-based role, and candidates located in the continental United States will be considered. + For this position, there is a preference to hire in the Central and Eastern Time Zone; however, candidates in other areas/time zones would be considered as well. **_Travel Requirements_** Expected travel is minor for this role. **_Essential Functions_** + Design, maintain, and improve company and contact entity workflows, SOPs, SLAs, and quality standards + Define and track KPIs for team efficiency, business impact, financial stewardship, and client satisfaction + Oversee entity creation, updates, merges, conflict resolution, and exception handling + Partner with automation, engineering, and data science to integrate and optimize human-in-the-loop and machine-assisted processes + Analyze performance patterns to identify automation gaps, reduce manual interventions, and continuously improve processes + Lead, mentor, and develop CEM team members + Establish performance expectations, work allocation, and capacity planning + Manage relationships with third party data providers and offshore vendors + Collaborate closely with Engineering, Product, Sourcing, and Sales to align CEM standards with business and platform needs + Participate in roadmap discussions, attribute model design, and classification/taxonomy updates **_Education Requirement_** Bachelor's degree in Information Systems, Data Analytics, Supply Chain Management, Computer Science, Engineering, Operational Management, or related technical fields or equivalent education and work experience. **_Required Experience, Knowledge and Skills_** + 7+ years of experience in data operations, master data management, digital operations, or business transformation + 2+ years managing teams + Proven experience managing both onshore and offshore teams + Experience with SQL and/or Python programming + Advanced problem solving and data driven decision making capabilities + Proven record of managing external vendor relationships + Ability to translate technical concepts into actional business insights for non-technical stakeholders + Experience with automation tools, scraping frameworks, and data pipelines + Exposure to data operations utilizing machine learning and data enrichment techniques + Proficiency in data governance, KPI management, and quality assurance + Strong project management skills, including planning, prioritization, and execution of change management + Excellent written and verbal communication skills for presenting strategies, reporting performance metrics, and building relationships with stakeholders **_Preferred Experience, Knowledge and Skills_** + Data Visualization tools such as AWS Quicksight, PowerBI, Tableau + Knowledge of construction industry or content workflows a plus + Experience with salesforce a plus + Familiarity with cloud-based data environments + Familiarity with Jira/Confluence **_About Dodge Construction Network_** Dodge Construction Network exists to deliver the comprehensive data and connections the construction industry needs to build thriving communities. Our legacy is deeply rooted in empowering our customers with transformative insights, igniting their journey towards unparalleled business expansion and success. We serve decision-makers who seek reliable growth and who value relationships built on trust and quality. By combining our proprietary data with cutting-edge software, we deliver to our customers the essential intelligence needed to excel within their respective landscapes. We propel the construction industry forward by transforming data into tangible guidance, driving unparalleled advancement. Dodge is the catalyst for modern construction. **_Salary Disclosure_** Dodge Construction Network's compensation and rewards package for full time roles includes a market competitive salary, comprehensive benefits, and, for applicable roles, uncapped commissions plans or an annual discretionary performance bonus. **_For this role, we are only considering candidates who are legally authorized to work in the United States and who do not now or in the future require sponsorship for employment visa status._** **_A background check is required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job and consistent with all federal state and local ordinances._** **_Reasonable Accommodation_** **_Dodge Construction Network is committed to recruiting, hiring, and promoting people with disabilities. If you need an accommodation or assistance completing the online application, please email_** **_***************************_** **_._** **_Equal Employment Opportunity Statement_** **_Dodge Construction Network is an Equal Opportunity Employer. We are committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All employment decisions shall be based on merit, qualifications, and business needs without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law._** \#LI-Remote \#LI-CS1 \#DE-Remote \#DE-2026-22

For more than 95 years, Standard Process Inc. has been a visionary leader in whole food nutrient solutions. Our whole food philosophy and mission to change lives extends far beyond our supplements to the very people we employ. We value compassion, accountability, respect, and excellence. This strong foundation has created an environment where our employees are seen as members of our family and are given the tools and resources to succeed, both personally and professionally. The Opportunity Under the direction of the Sr. Manager, Software Engineering, the Manager, Software Quality leads the Software Quality function within the Build pillar, providing player‑coach leadership to Software Development Engineers in Test (SDET) and Software Quality Analysts (SQA). The role establishes a Continuous Quality program-embedding automated and manual testing into CI/CD, defining quality gates, and publishing actionable quality metrics-to accelerate delivery while reducing risk and defect escape. The Manager partners with Agile Delivery (Plan) on acceptance criteria and UAT readiness, with IT Operations (Run) on release readiness and environment stability, and with Security & Compliance (Protect) to ensure secure‑by‑design practices and compliance in regulated areas. What You'll Do People Leadership & Team Operations Lead a multidisciplinary team of SDET/SQA professionals; set goals, run 1:1s, coach career growth, and manage performance. Recruit, onboard, and develop talent across IC and Team Lead levels; build a culture of engineering excellence, psychological safety, and customer focus. Establish coverage for release/regression windows as needed; maintain training plans and skills matrices. Quality Strategy & Governance Define the test strategy and test pyramid (unit → service/API → UI) with risk‑based testing aligned to product criticality. Set quality gates for CI/CD (minimum unit coverage, static analysis, vulnerability checks, integration/UI automation pass thresholds) and enforce entry/exit criteria for test phases and releases. Own software quality SOPs, templates, and definitions of ready/done; ensure traceability from requirements to test evidence. Publish a quality scorecard and dashboards; track defect escape rate, test coverage, deployment frequency, change failure rate, and lead time for changes. Test Engineering & Tooling Direct automated testing (unit, API/service, UI, contract) integrated into CI/CD; drive suite stability, speed, and signal‑to‑noise. Oversee manual/exploratory testing for complex, usability, and risk‑based scenarios; manage test case design, data, and environments. Drive non‑functional testing (performance, accessibility, reliability); coordinate synthetic and canary tests with Operations. Champion shift‑left practices (peer reviews, static analysis, SAST/DAST, security test patterns) and manage defect lifecycle from triage to closure. Evaluate and implement tooling-including opportunities for AI‑assisted automation-balancing velocity, reliability, and compliance. Release & Environment Management (in partnership) Enforce release readiness (test results, risk assessments, rollback/runbooks); provide quality sign‑off for Build‑owned services. Coordinate non‑prod/prod environment usage, test data refreshes, and deployment windows with DevOps and Run; ensure CI/CD quality gates are effective and auditable. Participate in Change Enablement (CAB) representing Build for quality risk; retain evidence for audits and validation. Incident / Problem / Change (Build scope) Provide L3 application SME support; join MIM bridges for Build‑owned services; validate hotfixes and post‑release checks. Lead/Co‑lead RCAs when software defects are causal; convert findings into tests/guardrails and backlog items; update KEDB. Accountable for the quality of Build‑originated changes; ensure peer review, test evidence, and back‑out plans; coordinate with Run on deployment windows and with Protect on risk/compliance review. Cross‑Pillar Collaboration Partner on clear acceptance criteria, UAT planning, and business readiness; ensure production defects are captured with actionable detail. Align on incident/problem trends; co‑own release quality and post‑release validation; integrate monitoring hooks and SLOs into tests. Embed secure‑by‑design checks and coordinate remediation/verification of security defects in the pipeline; maintain evidence. Compliance & Documentation Ensure testing and validation practices satisfy regulatory and quality requirements (e.g., FDA/GMP CSV, HIPAA, PCI) for applicable systems. Maintain audit‑ready evidence (test results, approvals, traceability) and SOP adherence; participate in internal/external audits. What You Bring Education & Certifications Bachelor's degree in Information Technology, Computer Science, Engineering, or related field required; equivalent experience considered. ISTQB Foundation (or equivalent) required; Advanced/Manager, Agile‑testing, or automation certifications preferred. Experience 8+ years in software quality assurance/engineering with 3+ years leading teams and/or managing quality programs. Demonstrated experience embedding automation in CI/CD and operating quality gates across multiple product teams. Hands‑on with test automation frameworks (e.g., Selenium, Playwright, Cypress, Postman) and at least one programming/scripting language. Experience coordinating UAT and production release quality in agile environments; familiarity with DevOps toolchains. Experience in regulated environments (e.g., FDA/GMP CSV, HIPAA, PCI) preferred. Specialized Knowledge & Skills Strong leadership and coaching skills; able to set direction, prioritize under pressure, and hold teams and partners accountable. Excellent communication and executive presence; builds trust with engineers, product leaders, and auditors. Data‑driven decision making; experience with quality analytics and continuous improvement. Customer‑first mindset; pragmatic balance of velocity and quality. Necessary Competencies Integrity & sound judgment under pressure Ownership & reliable follow-through Customer empathy (accessibility, performance, reliability) Crisp, audience-aware communication Influence without authority; cross-pillar collaboration Systems thinking with analytical rigor (uses meaningful metrics) Bias for automation & simplification Adaptability, learning agility, and resilience Talent development & coaching; inclusive leadership Travel Requirements Minimal travel required. Why Standard Process? Standard Process is proud to be a top workplace! We offer a comprehensive and competitive benefit package, which includes: Competitive salary and annual incentive program Comprehensive health care and flexible benefit plan, including pet insurance Company-matched 401(k) plan Profit sharing plan On-site childcare with highly accredited curriculum Platinum WELCOA award-winning wellness program, including: On-site 24x7 fitness center Whole food court On-site chiropractic care On-site massage therapist Personal trainer Daily fitness classes On-site life coach $450 monthly Standard Process supplement allowance Paid time off and holiday time Educational assistance Company hosted outings and events Strong community involvement Standard Process understands the importance of diversity and believes in providing equal employment opportunity for all employees and applicants for employment. Accordingly, all personnel decisions, including but not limited to hiring, compensation, promotions, training, benefits, termination, or other terms and conditions of employment, are made without regard to age, race, creed, color, disability, veteran status, marital status, sex, national origin, ancestry, arrest or conviction record, sexual preference, genetic information, or any other legally protected characteristic in accordance with law.

Testing software that saves lives. Join the Quality Management team at Epic and become the last line of defense for software that impacts the lives of 305 million people worldwide. As a Quality Manager, you'll collaborate closely with developers, crafting intuitive tools for health organizations, testing new features, uncovering bugs in our software, and overall making our software a joy to use. You'll apply your extensive language skills to clearly and accurately prepare a wide range of technical documentation, training materials, and other written materials related to Epic's software. This role offers exceptional flexibility, allowing Quality Managers to specialize in areas such as software usability design, technical automation, or project coordination for customer software installations. Bring your intelligence, curiosity, and creativity, and we'll equip you with the knowledge needed to excel. Together, we'll shape the future of healthcare technology. Learn more about our team at *********************************************** Test the limits of our software for the most innovative health systems on the planet. The top-ranked health systems in U.S. News and World Report are Epic customers. Our community includes major systems like the Mayo Clinic, Johns Hopkins, Cleveland Clinic, and Kaiser Permanente, as well as leading academic medical centers at the University of Wisconsin, University of Michigan, University of California, University of Texas, The Ohio State University, and many more. Live affordably in a city known for its rising tech talent. Epic is located just outside Madison, Wisconsin, the second fastest growing market for tech talent in the United States and home to the state capital and the University of Wisconsin. Madison, a city surrounded by water, has received accolades for being the greenest city in America (NerdWallet), the best city for renters (SmartAsset), the fittest city in America (Fitbit), and the third best metro in the US for young professionals (Forbes Advisor). More than just important work. Our uniquely themed campus was designed to heighten your ability to get stuff done in your office, a conference room, or by the fireplace in a comfy chair. All meals are restaurant-quality but cost only a few dollars, and they're prepared by a team comprised of kitchen talent from restaurants around the country. And, after five years here, you'll earn a four-week sabbatical anywhere in the world. Staff have kayaked in Patagonia, attended a Beyoncé concert in Ireland, built a library in Tanzania, and run a marathon in Antarctica. We offer comprehensive benefits to keep you healthy and happy as you grow in your life and career, and your merit-based compensation will reflect the impact your work has on the company and our customers. You'll also be eligible for annual raises and bonuses, as well as stock grants, which give you an even greater stake in the success of Epic and our customers. Healthcare is global, and building the best ideas from around the world into Epic software is a point of pride. As an Equal Opportunity Employer, we know that inclusive teams design software that supports the delivery of quality care for all patients, so diversity, equity, and inclusion are written into our principles. Please see our full non-discrimination statement at ***************************** Requirements * Bachelor's degree or greater (any major) * Excellent knowledge of one of the following languages: * Arabic * Armenian * Haitian Creole * Hmong * Italian * Russian * Vietnamese * Relocation to Madison, WI area (reimbursed) * Knowledge of Epic software is not required, we will train you! * COVID-19 vaccination * Eligible to work in the United States without visa sponsorship

IPMPC LLC. is a rapidly growing manufacturer that has been designing and distributing high quality retort products. We offer a rewarding work environment with advancement opportunities while maintaining a small company, employee-focused atmosphere. We are currently searching for Quality Manager to join our manufacturing team . Quality Manager Focus Area The key role of the Quality Manager is to drive the standards, within the pet food facility ensuring all products that go out the door are safe and to specification. Key focus being placed on complaints target/levels, micro & environmental issues, product quality, GMP's adherence to procedures. Be preventive not reactive. Always putting the customer needs first & reacting to their requests or complaints in a timely & concise manner. Building “Quality capability” across the site through training. Culture development and role modeling. Description and Responsibilities Management of the Food Safety, Quality and HACCP systems to ensure that they are systematic, comprehensive, thorough, fully implemented, effective and maintained. Management of process control checks, raw material / finished product testing and release procedures to ensure that products manufactured meet the specification and standards that have been agreed or are expected. Ensure any food safety or quality issues that cannot or are not being dealt with at the facility are communicated to the relevant function so that appropriate executive action can be undertaken. Lead, manage and coordinate all facility quality improvement activity. Management of customer, third party and regulatory audits. Management of the internal, GMP and Hygiene auditing systems. Actively promote a quality improvement culture and contribute to the development of quality systems and strategies. Manage, direct and coordinate the investigation of complaints relating to site production. including the necessary reporting, communication, and corrective actions, as per the site customer complaint procedure. Develop, maintain, and coordinate monthly quality reports with trend analysis to both site management and production operator levels. Manage the process and make decisions in respect of non-conforming product, and rework of rejected stocks. Responsibility for ensuring that the Major Incident Policy is fully implemented. Develop, manage, and coordinate the training needs identification process for Food hygiene standards, HACCP, Hygiene training, and/or all other prevailing quality related requirements and standards for all staff on the site. Coordinate and ensure the provision of information to customers in a timely and efficient manner (certificates, reports, general enquiries, etc.). As a key member of the site management team, contribute to the Plant Management and decision making, and activity of the Plant Management team. Responsibility for managing and achieving the departmental budget and all prevailing departmental Key Performance Indicators. Assist in the development and implementation of quality KPI's for the site. Responsibility for managing, leading, and directing all staff reports and/or teams. Manages all people matter relating to the Quality department developing and supporting the team as appropriate e.g. motivating, delegating, performance management, coaching, appraisals, recruiting, and identifying & arranging job related and development training. Deputize staff member to cover in the absence of other site-based Quality personnel -supporting and working at other sites as required from time to time. Undertakes training and trains others as identified by management for the proper discharge of duties or future requirements. Any other reasonable tasks or duties as required by management. This list is not exhaustive and is designed to be an outline of the scope of the role. Develop and Write SOPs. Qualifications Degree in a Food Science related subject. Proficient written, numerical, and verbal skills. Fluency of English language. Numerical ability to record, interpret and analyze key process date. Experience leading a team that continually seeks a better way. Experience working in Food Manufacturing environment. Experience leading continuous improvement activities such as RCA, process capability. Understanding of Food Safety and Quality Management systems essential. Knowledge of the BRC, FSSC 22000, Global Food Standards and specific customer standards as they apply. The ability to communicate targets & goals in a clear concise fashion and provide space and time for team members to deliver against these. To be very structured and disciplined in adherence to standards set. To be an example to all team members of how things should be done. Proficient in the use of MS Office tools. Must be able to Read, Write, and Speak English

Job Description Workforce Solutions partners with companies to find the perfect match between top talent and the right role. If you're seeking a new job in the Audit field within the public accounting industry, submit your resume today! Some job titles you may be seeking could include: Staff Auditor Assurance/Audit Associate Senior Auditor Senior Assurance/Audit Associate Assurance/Audit Senior Assurance/Audit Manager Senior Assurance/Audit Manager Assurance/Audit Director Assurance/Audit Partner Assurance/Audit Partner-in-Charge Peer Reviewer By joining our talent network, you'll gain access to job openings that match your skills, experience, and career goals. Whether you're looking for a full-time, part-time, remote, hybrid, or onsite position, our team of expert recruiters is dedicated to connecting you with roles that fit your needs. Ready to find your next opportunity? Submit your resume, and let us help you take the next step in your career journey!

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The QA Specialist I - Doc Control will manage, coordinate, and maintain CGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. . • Maintain DCR/Quality system event databases and Master Documents / List • Maintain Designated Satellite Areas for controlled paper based record management system • Create Labels as needed • Facilitate Client Batch Record Creation / Modifications / Approvals • Issue and Archive Batch Records / Testing Data Capture Sheets / Lab Books / Equipment Log Books / Room Log Books/Quality system event documents • Facilitate Biennial SOP reviews • Maintain Document / Material / Batch Numbering Logs • Obsolete Documents • Writes and develops QA SOPs under minimal supervision • Independently Develops/implements new systems for Document control under minimal supervision • Manage Record / Document Filing system • Proof and edit document changes including minor SOP updates, if necessary • Assist with Line Clearances (Backup capacity) • Assist in audit preparation and reconciliation • Other duties as assigned Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. • Requires the ability to communicate effectively using speech, vision, hearing and written word • Requires bending, squatting, climbing, reaching • Requires the ability to lift, carry, push or pull light weights (up to 20 pounds) Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Interacts with all departmental staff, including giving training and/or presentations to large groups • Work is completed in an office environment where the noise level is typically moderate Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Exceptional Organizational Skills • Competent in MS Office • Professional Verbal and Written Communication Skills Required • Data Processing, Spreadsheets, SOP Generation • Prior GMP experience preferably in a the pharmaceutical manufacturing industry • High School Diploma/associates degree with a Minimum of ten years in a cGMP Environment; 5-10 year previous experience with Bachelor's degree • Detail Oriented • Strong multitasker who is comfortable working in a fast paced • Team oriented and strong collaborative approach to work #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Job Title: Production Quality Manager Department: Quality AssuranceReports To: Director of Quality We are seeking a highly motivated and experienced Production Quality Manager to lead our quality assurance program for manufacturing operations. The ideal candidate will play a critical role in ensuring that our products meet rigorous defense industry standards, government regulations, and customer specifications. This position requires a strong understanding of quality management systems, production processes, and compliance requirements. The Production Quality Manager will lead a team of quality professionals and collaborate closely with production, engineering, and program management teams to drive continuous improvement and ensure the delivery of high-quality, mission-critical products. Key Responsibilities Quality Leadership Lead, mentor, and develop a team. Act as the primary point of contact for quality issues with customers, government representatives, and regulatory agencies. Provide training and guidance on quality standards, processes, and tools to employees at all levels Guide new products from concept through product realization Implement and monitor key performance indicators (KPIs) to measure and improve product quality and production efficiency Manage quality control activities throughout the production lifecycle, including incoming materials, in-process inspections, and final product testing Production Oversight Identify and resolve production quality issues by driving root cause analysis and implementing corrective/preventive actions. Develop, implement, and maintain quality assurance processes and procedures to meet applicable defense and nuclear industry standards (e.g., ISO 9001, ASME NQA-1, MIL-STD, ITAR, FAR/DFARS) Oversee audits (internal, customer, and third-party) and ensure non-conformances are documented and resolved in a timely manner Continuous Improvement Champion Lean, and other process improvement initiatives to reduce defects, improve efficiency, and lower costs. Analyze production and quality data to identify trends, risks, and opportunities for improvement. Lead efforts to implement advanced quality tools, such as Statistical Process Control (SPC), Failure Modes and Effects Analysis (FMEA), and Design of Experiments (DOE). Qualifications Education & Experience Bachelor's degree (Engineering or Technical field preferred) Minimum of 7 years of experience in quality management within a manufacturing environment, preferably in the defense, aerospace, or high-tech industries. Experience with defense contracting and government compliance standards (e.g., ITAR, FAR/DFARS). Skills & Certifications Strong knowledge of quality management systems and tools. Familiarity with defense and military standards and requirements. Quick Response Manufacturing QRM or equivalent certification preferred. ASQ Certified Manager of Quality and Operational Excellence Proficient in quality tools and software, including SPC, FMEA, and root cause analysis techniques. Excellent leadership, communication, and problem-solving skills. Ability to interpret engineering drawings, technical specifications, and production schedules. Additional Requirements This position requires access or potential access to Unclassified Naval Nuclear Propulsion Information, which is Not Releasable to Foreign Nationals (NOFORN) data. Therefore, to meet NOFORN requirement, you will have to provide proof of US Citizenship and attest that you do not have dual citizenship. Acceptable proof of US Citizenship is a US Passport, US Birth Certificate or Naturalization Certificate. Ability to obtain and maintain a security clearance. Flexibility to travel to suppliers, customers, or other company locations as needed. Physical Demands & Work Environment Work is performed in a combination of office and manufacturing environments. Ability to occasionally lift objects weighing up to 35 pounds. Accurate color vision (Jaegar J1 and color panels) Use of personal protective equipment (PPE) required in production areas. What We Offer Competitive salary and benefits package. Opportunities for professional growth and development in a mission-critical industry. A collaborative and dynamic work environment where your contributions make a difference. This specification is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision. Ability to competently perform all the essential duties of the position, with or without reasonable accommodation, demonstrated commitment to effective customer service delivery, and the ability to work productively as a member of a team or work group are basic requirements of all positions at Fairbanks Morse. Join our team and contribute to the production of high-quality, reliable products that support national security and defense missions. Apply today!

The purpose of this position is to provide medical device quality assurance support at Arrowhead. This position will report to the Director, Supply Chain Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will provide Medical Device Subject Matter Expertise to support Quality and project teams to ensure clinical and commercial product quality are in compliance with relevant US and ROW medical device regulations, guidance, and laws. Responsibilities * Serve as an internal medical device subject matter expert, both US and ROW, for all relevant elements of QMS and quality of combination product development and commercialization, assuring proper integration and support of device regulations, including, but not limited to Change Management, Risk Management, DHF/DMR Maintenance, Internal Audits, etc. * Monitor, guide, and ensure internal stakeholders' decision-making and actions are consistent with QSR, ISO 13485, ISO 14189, Good Distribution Practices (GDP), relevant international laws and guidance, and Arrowhead policies and procedures. * Develop, define, support, review, augment, and/or approve a variety of controlled documents to ensure adherence to Medical Device Regulations and requirements. * Identify gaps in existing processes, as well as need for new processes. Collaborate with cross-functional teams for solution development and implementation. * Provide quality guidance to internal stakeholders and project teams during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation. * Support continuous improvement to the combination product QMS, monitoring and identifying areas for improvement. * Support development and management of Supplier Quality activities such as Quality Agreements, supplier audits, and assessment and performance evaluations (SCARs, Customer Notifications, etc.) * Support internal audits, certifications, and regulatory inspections at Arrowhead and its suppliers. * Review Clinical Study Plans that include device instructions. Requirements: * BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred * Minimum of eight (8) years industry experience in Quality Assurance, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility. * Medical Device experience required. Combination Product and Supplier Quality experience preferred. * Knowledge of GxP, focus on QMS, QSR, as well as ICH/FDA, EU MDR, ISO 13485 guidance documents and standards applicable to clinical and commercial products. Preferred: * Works independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment. * Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels. * Ability to consistently communicate with external parties in a professional manner. * Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet. * Ability for occasional business

Endsulin (***************** is a cutting-edge pre-clinical gene therapy startup biotechnology company in Madison, WI. Our primary goal is to develop a gene therapy to treat diabetes for the millions of people suffering from diabetes worldwide. Endsulin is located at University Research Park in the Forward Biolabs co-working biotechnology incubator. Job Description The Director of Quality Assurance and Regulatory Affairs (QA/RA), you will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality products enter emerging, regulated, and clinical global markets. You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company. Continuous improvement and ad-hoc issue resolution to drive improvement of quality operations, at the lowest costs and in full compliance of all relevant regulations and standards. This role is ideally suited to a candidate who is self-motivated and excited by an opportunity to rise to frequent and diverse challenges. Qualifications Duties/Responsibilities • Responsible for development, implementation, maintenance, and overall success of the company's quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality. • Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy. • Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. • Ensure that regulated processes and systems are always inspection ready. • Oversee the performance of internal and external audits. • Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. • Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RA functions • Serve as person responsible for regulatory compliance (PRRC). • Other duties as assigned. Skills & Abilities • Extensive experience hosting regulatory inspections and interacting with regulators • Strong understanding of global registration requirements and demonstrated track record of successful market access. • Experience with computer software validation (CSV) and implementation for QMS and ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution • General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices • Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management • Proven ability to create culture of accountability and ownership • Proven track record with establishing and maintaining strong internal and external partnerships. • Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. • Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. • Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. • Highly independent and self-motivated and integrates well within a team. Physical Demands • Ability to remain seated for long periods of time while working on computer or referring to documents. • Must have manual dexterity to operate computer keyboard and standard office equipment. • Positions: Standing, walking, sitting, stooping. • Ability to travel. Education • Bachelor's degree required in a science, engineering field or related discipline. • MBA is a plus Experience • 10 years of QMS experience and demonstrated leadership experience. • Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT); CFR's parts 210 &211. Additional Information All your information will be kept confidential according to EEO guidelines.