Quality Assurance Specialist
Quality assurance manager job in Waunakee, WI
The Operations On-Site QA Specialist will be introduced to the on-site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP QA setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the Operations On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below.
Conducts on the floor reviews of all manufacturing and testing operations.
Performs verifications required to support manufacturing and testing documentation (including but not limited to batch records, cleaning records, logbooks, and test methods).
Assists all departments in the identification and evaluation of facility events.
Performs on the floor reviews of executed batch records.
Assists in the organization and/or the establishment/maintenance of relevant procedures/documents.
Assists in audits where necessary.
Supports the document control team in issuing records as needed.
Performs other duties as assigned
Data Quality Engineer
Quality assurance manager job in Madison, WI
About FAC Services
Want to build your career helping those who build the world?
At FAC Services, we handle the business side so architecture, engineering, and construction firms can focus on shaping the future. Our trusted, high-quality solutions empower our partners, and our people, to achieve excellence with integrity, precision, and a personal touch.
Job Purpose
FAC Services is expanding our QA team with a strategic new hire: a Data Quality Engineer who will play a pivotal role in ensuring the quality and reliability of our data infrastructure. This role will focus on testing data pipelines, validating data integrity across systems, and supporting infrastructure automation efforts. You'll collaborate closely with Infrastructure, DevOps, and QA teams to build scalable, test-driven solutions that support our growing data ecosystem.
This is a hybrid position, and candidates must reside within 60 miles of Madison, WI.
Primary Responsibilities
The Data Quality Engineer will be responsible for ensuring the quality and reliability of data pipelines, APIs, and infrastructure automation. This includes designing and executing automated tests for ETL/ELT workflows, validating data integrity across cloud platforms, and performing extensive API endpoint testing. The role also involves supporting Infrastructure as Code (IaC) testing using tools like Ansible, ARM, and Bicep, and contributing to CI/CD pipelines and Azure-based testing initiatives.
Data Quality & Pipeline Testing
Design and implement automated tests for ETL/ELT pipelines and data marts.
Validate data transformations, integrity, and quality across Azure, Snowflake, and Microsoft Fabric environments.
Collaborate with developers and data engineers to implement test-driven development (TDD) practices for APIs and data workflows.
Ensure confidence in data quality through rigorous testing of data pipelines and integrations.
API Endpoint Testing
Perform extensive testing of RESTful API endpoints, including functional, regression, and integration testing.
Validate API responses, error handling, and performance under various conditions.
Work closely with developers to ensure comprehensive test coverage and early detection of issues.
Use tools such as Postman, Swagger, or custom scripts to automate and document API testing.
Infrastructure as Code (IaC) & Automation
Support infrastructure automation testing using tools like Ansible, ARM templates, Bicep, and Power Automate.
Contribute to the development of reusable QA frameworks that integrate with existing systems.
Participate in the design of automated provisioning and deprovisioning workflows for infrastructure and user hardware.
Cloud & System Testing
Assist in testing hybrid Azure environments, including network, security, scalability, and fuzz testing.
Collaboration & Leadership
Work cross-functionally to ensure QA alignment across infrastructure and application teams.
Lead by example, demonstrating best practices and continuous improvement.
Share knowledge and mentor team members in data quality and automation practices.
Qualifications
To perform this job successfully, an individual must be able to perform each primary duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Experience
3+ years in QA engineering, specializing in data testing/infrastructure
Extensive ETL/ELT testing, data validation, and quality frameworks experience
Skilled in SQL and scripting (Python, PowerShell)
Knowledge of CI/CD tools and workflows (Git, Azure DevOps)
API testing experience; familiar with Swagger documentation
Understanding of IaC tools (Ansible, ARM, Bicep)
Microsoft Azure expertise
Strong communicator and effective team player
Quality Supervisor-3rd Shift
Quality assurance manager job in Darien, WI
Reporting to the QA Manager, you will provide guidance, technical assistance and scheduling to quality assurance technicians and associates. As a quality assurance professional, you are involved in all aspects of quality and safety including audits, HACCP program evaluation, GMP training, sanitation evaluation, pest control, purchasing supplies, working with operations personnel on quality and safety issues, inspecting returned and incoming products, customer complaints, implementing policies and procedures and evaluating new equipment installation or repair.
What You Will Do:
Coordinate quality assurance activities (e.g., audits, training, purchasing, etc.)
Provide technical assistance and training to QA personnel
Monitor and verify the HACCP plan's CCPs following policy and procedure
Conduct GMP and sanitation audits of operations and warehouse areas
Work with operations personnel on quality and safety issues
Verify operations control systems are functional and being followed
Places product on hold, release or disposition while adhering to policy and procedure
Evaluate damaged products
Coordinates resolution of customer complaints as necessary
Ensure SPC Management practices are followed
What You will have:
BS Degree in Biology, Microbiology, Chemistry, Food Science or other related degree required. Education may be substituted for years of experience.
3+ years related experience required preferably in the food industry
1+ year of supervisory experience, managing a team of people
Experience with Food Safety Guidelines/Good Manufacturing Practices (GMPs) and safe practices and procedures
Experience with HACCP Plans
Understanding of government regulations (FDA, USDA)
Familiar with Fundamentals of Total Productive Maintenance (TPM)
Large organization/corporate experience
What You Can Expect Physically:
Regular standing, walking, and communication throughout the shift.
Occasional lifting or moving of items up to 50 pounds, along with tasks that involve reaching, kneeling, or crouching.
Work in an environment with varying temperatures and noise levels.
Visual acuity required for close and distance vision, color differentiation, and depth perception.
Reasonable accommodation provided to support individuals with disabilities in performing essential job functions.
Relocation assistance is available for this position. Preference will be given to local candidates.
#LI-Onsite
#LI-Associate
#LI-MW1
Compensation:
Pay Range:$63,000-$93,000
The annual salary listed above is the expected offering for this position. An employee's actual annual salary will be based on but not limited to: location, relevant experience/level and skillset, while balancing internal Conagra employees' equity. Conagra Brands will comply with applicable law regarding minimum salaries for exempt employees.
Our Benefits:
We care about your total well-being and will support you with the following, subject to your location and role:
Health: Comprehensive healthcare plans, wellness incentive program, mental wellbeing support and fitness reimbursement
Wealth: Great pay, bonus incentive opportunity, matching 401(k) and stock purchase plan
Growth: Career development opportunities, employee resource groups, on-demand learning and tuition reimbursement
Balance: Paid-time off, parental leave, flexible work-schedules (subject to your location and role) and volunteer opportunities
Our Company:
At Conagra Brands, we have a rich heritage of making great food. We aspire to have the most impactful, energized and inclusive culture in food. As a member of our 18,000+ person team across 40+ locations, you are empowered to reach your potential, make an impact and own your career. We're in the business of building champions - within our people and our iconic brands like Birds Eye , Slim Jim and Reddi-Wip .
Our focus on innovation extends beyond making great food, it also reflects our commitment to embracing new solutions that positively impact our team, the communities we serve and the health of our planet. Foodies Welcome.
Conagra Brands is an equal opportunity employer and considers qualified applicants for employment without regard to sex, race, color, religion, ethnic or national origin, gender, sexual orientation, gender identity or expression, age, pregnancy, leave status, disability, veteran status, genetic information and/or any other characteristic or status protected by national, federal, state or local law. Reasonable accommodation may be made upon request.
Director of Quality Assurance & Regulatory Affairs (QA/RA)
Quality assurance manager job in Madison, WI
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.
Supplier Quality Talent Community - General Interest Pipeline
Quality assurance manager job in Madison, WI
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.
Auto-ApplySr. QA Manager
Quality assurance manager job in Madison, WI
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 Senior QA Manager will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role supports and provides quality oversight of the day-to-day operations of the Madison, WI based drug manufacturing facility. In this role, the opportunity exists for the incumbent to shape and transform GxP programs by providing QA expertise and guidance to lead product candidates and pipeline assets. The incumbent will also be a key member of a cross functional team focused on harmonization and improvement of quality systems and processes across all PCI WI GMP locations.
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.
Provides quality oversight of manufacturing activities on a day-to-day basis.
Review, develop, and improve quality system procedures, specifications, and test methods.
Provide status reports, including relevant quality metrics and participates in the management review process.
Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
Monitor, identify, and propose quality process/system improvements and provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
Serve as QA representative to cross functional project teams such as process improvement.
Perform risk assessments to comply with internal procedures and external guidelines.
Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable.
Ensures site readiness for regulatory inspections, client audits, and internal audits.
Perform review of raw material documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization.
Assist with internal audits, client audits as well as supplier audits as needed. Review and approve supplier documents requiring Quality approval.
Interface with internal and external customers to address any documentation and compliance concerns.
Provides oversight to Quality walkthroughs for Shutdown and Inspection Readiness activities and ensures compliance with site and corporate procedures.
Establish and communicate performance objectives for Quality Assurance staff that are consistent with the business's unit goals, Quality and Technical Operations objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
May provide Quality review and approval of investigations, deviations, events, change controls and CAPAs.
Hires, integrates, and develops high quality talent, capable of delivering against the department's goals and objectives.
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.
EDUCATION AND PROFESSIONAL EXPERIENCE
Knowledge of science generally attained through studies resulting in a BS degree in Science, Engineering, Biochemistry or related discipline, or its equivalent is required. ASQ certification preferred. ASQ certification preferred.
Minimum of 8 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production. Minimum of 2 years of management responsibility preferred.
A minimum of 8 years of overall experience in biopharmaceutical quality
Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.
Experience performing RCA, technical writing, and working with quality related investigations.
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of US and EU cGMP regulations and guidance
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
Background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing with oversight of final product release.
Knowledge in Operational Excellence and Continuous Improvement is highly desirable.
Experience in building and growing an organization into a high-performance team.
Knowledge of electronic systems including any of the following Master Control, or electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.
PERSONAL SKILLS & COMPETENCIES
Exceptional organizational skills
Ability to make risk-based decisions and resolve issues with minimal guidance.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Proficiency in MS Office including Word, Excel, Access, and Visio
Ability to lead people in a dynamic, fast-paced work environment.
Honesty, integrity, respect, and courtesy with all colleagues
Creative with the ability to work with minimal supervision and balanced with independent thinking.
Resilient through operational and organizational change
Demonstrated leadership, interpersonal, communication, and motivation skills.
Well-practiced in exercising sound judgment in decision-making
Demonstrated multitasking and organization skills.
Past experience where one was required to work in a team-based environment with a diverse group of people. Previous work responsibility, which required a high degree of attention to detail.
#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.
Auto-ApplyDirector, Quality & Regulatory Business Development-2
Quality assurance manager job in Madison, WI
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 $139,200.00-$208,800.00 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
Epic - Quality Manager, application via RippleMatch
Quality assurance manager job in Madison, WI
This role is with Epic. Epic uses RippleMatch to find top talent.
Quality Manager
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. 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.
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.
Experience our state-of-the-art campus, eat delicious food, and travel the world.
We don't believe in cubicles. (Well, we believe they
exist
, but…) 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. For lunch, visit King's Cross or Cassiopeia for a wide array of meal options, or go to one of our smaller, themed bistros, featuring wood-rotisserie, pan-Asian, and Latin-inspired cuisine. 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.
Live affordably in a city known for its rising tech talent.
Epic is located just outside Madison, Wisconsin, which is the second fastest growing market for tech talent in the United States, home to the state capital, and the University of Wisconsin. Madison has received accolades for being the greenest city in America (NerdWallet), the best city for renters (SmartAsset), the fittest city in America (Fitbit), and it has the highest concentration of millennial talent in the country (Inc.).
More than just important work.
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. Research has shown that job-seekers who are women, LGBTQ+, or members of historically underrepresented communities are less likely to apply for roles they don't seem completely qualified for, so we encourage all who are interested to apply. Please see our full non-discrimination statement at *****************************
Requirements
Bachelor's degree or greater (any major)
A history of academic and professional success
Willingness to travel 25-60% of working days, with a typical month including 1-2 trips lasting 2-4 days
Eligible to work in the United States without visa sponsorship
Relocation to the Madison, WI area (reimbursed)
COVID-19 vaccination
Auto-ApplyQuality Assurance Manager
Quality assurance manager job in DeForest, WI
Job Details Deforest Plant - Deforest, WIDescription
The Quality Assurance Manager is responsible for managing all Quality Assurance functions within their plant and to
follow procedures and embrace new technologies
.
Responsibilities:
Treat all internal and external contacts with uncompromising respect and integrity under all circumstances.
Develop and perform product and system audits to measure quality performance.
Lead team on product launch, validation (APQP/PPAP) and improvement efforts with an objective of ZERO defects.
Update and create procedures in compliance with the Corporate Quality mandate.
Ensuring awareness of customer requirements is promoted throughout the organization.
Function as a liaison between the customer and EVCO Plastics to resolve quality concerns.
Prepare management & customer reports with analytical data as required.
Ensure that on-going production meets the customer expectations with supporting evidence.
Coordinate activities to ensure compliance with Corporate Quality policies.
Administer and enforce company policies and disciplinary action procedures.
Provide overall direction of quality assurance personnel.
Interview, assist with the selection and training of new employees.
Shall ensure compliance to all legal and safety regulation regarding the operation of Evco facilities and compliance to all FDA regulation where applicable to the products produced.
Follow company safety procedures to ensure your safety as well as the safety of others.
Attend team meetings to promote team building.
General housekeeping to keep the work area and plant clean.
Qualifications
Qualifications:
Required:
Ability to communicate effectively with people at all levels of the organization
Bachelor Degree in Industrial or Quality Engineering or equivalent experience
GD &T knowledge and ability to use measurement instruments
Management skills necessary to direct the smooth operation of Quality Assurance functions
Working knowledge of Quality Assurance and the plastic injection molding process
Blueprint reading and proficient with MS Office
Self-motivated team player with a positive attitude
Organizational skills and maintain good attendance
Preferred:
ASQ-CQE, CQA Certification
QA Auditor
Quality assurance manager job in Madison, WI
**Join our Labcorp Quality department as a Quality Auditor in Madison, WI.** Are you wanting to move your career into the Quality department? This is a full-time benefitted, day position at the Madison, Wisconsin facility in the Quality department auditing the Immunology and Immunotoxicology work. Take your career to another level maintaining Quality!
**Join an exceptional organization and an exceptional Quality department.**
**Job Summary:**
- The individual in this role verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and in-lab phase audits where applicable for specific study types, participate in internal facility/process and/or supplemental inspections, and peer review QA SOPs. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g. Good Clinical Practice (GCP), and 21 CFR Part 58 Good Laboratory Practice (GLP) in the performance of their role.
**Job Duties:**
- Conduct, but not limited to protocol review, report/data audits, and internal facility/process inspections
- Peer review QA SOPs
- Support operational liaison meetings representing QA function
- Report on relevant quality metrics (for single topics/departments) and highlight trends
- Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed
**Minimal Experience and Education:**
- Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education
- Experience with plate reading technologies (e.g. MesoScale, EliSpot, BioPlex)
- Understanding of cell viability and cell potency testing
- General understanding of principles of flow cytometry
- 2 years in a regulatory environment
- Knowledge of and ability to interpret apply (applicable) regulations to monitor compliance
- Able to interpret data and identify quality critical problems
- Able to convey regulatory expectations
**Why People choose to work at Labcorp?**
At Labcorp, it's our people that make us great - it's what our clients, our partners and, most importantly, what our employees say. Here, you'll have the opportunity to work with extraordinary people with diverse viewpoints. You'll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends.
**Benefits:** Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here (************************************************************** **.**
**Labcorp is proud to be an Equal Opportunity Employer:**
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
**We encourage all to apply**
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site (**************************************************** or contact us at Labcorp Accessibility. (Disability_*****************) For more information about how we collect and store your personal data, please see our Privacy Statement (************************************************* .
Translation Quality Manager
Quality assurance manager job in Verona, WI
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
Quality Assurance Specialist
Quality assurance manager job in Madison, WI
ABS, Genus PLC has an exciting opportunity. We are looking for a Quality Assurance Specialist to support the ABS Operating System by executing and improving quality systems across ABS manufacturing sites.
This position is responsible for auditing, data analysis, training, and supporting continuous improvement initiatives aligned with Lean TPS principles. The specialist collaborates across regions to ensure consistent application of quality standards, drive root cause analysis, and embed a culture of first-pass quality and operational excellence.
This position is located in Wisconsin in the US and with international travel estimated at 10%.
The salary range for this position is $65,000 - 80,000 USD. The salary provided is a good faith estimate representative of all experience levels. Genus considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.
We would also consider employees working in other countries where Genus does business in LATAM, APAC and EMEA. Compensation and benefits would be aligned to that country.
You Will
Plan, execute, and oversee ABS operating system, process, and product audits to ensure adherence to standardized SOPs and quality requirements.
Maintain and improve global QMS functions such as Document Control, Change Control, and Auditing.
Track and investigate deviations, nonconformances, and customer complaints across regions, ensuring timely resolution and documentation.
Support harmonization of quality documentation and practices across global sites in alignment with the ABS Operating Model.
Collaborate with regional teams to ensure compliance with global quality system requirements and facilitate knowledge sharing.
Data Analysis & Reporting
Collect, interpret, and report production and quality data using statistical process control (SPC) and other analytical tools.
Monitor global quality KPIs and contribute to dashboards that support data-driven decision-making and continuous improvement.
Identify trends and systemic issues across sites, contributing to structured root cause analysis and corrective/preventive actions using tools such as A3, 5 Whys, and Fishbone diagrams.
Training & Capability Building
Develop and deliver global quality-related training on systems, policies, procedures, and core processes.
Collaborate with the Technical Training Manager and CI team to integrate Lean and quality principles into global training programs.
Provide coaching on risk assessment techniques and quality tools to cross-functional and cross-regional teams.
Collaboration & Continuous Improvement
Partner with Operations, R&D, Engineering, and CI teams globally to align quality efforts with business needs.
Participate in global Kaizen events, value stream mapping, and other CI activities to improve quality performance.
Support the deployment of Lean TPS principles and contribute to a culture of continuous improvement and operational excellence.
Other Duties
Comply with established global quality, safety, and environmental procedures and policies.
Perform other tasks as assigned by the Global CI & QA Manager.
Requirements
Demonstrates proficiency in application of QA system principles, concepts, industry practices, and standards and the interface with other functions like manufacturing, distribution, and maintenance.
Demonstrates strong verbal, technical writing, and interpersonal skills.
Knowledge of QA practices, theories, tools, and quality detection techniques
Experience in working with Microsoft Office, database software and QA applications
2+ years of relevant experience in a cGMP or an ISO-compliant environment (preferred).
Bachelor's degree in a scientific discipline with laboratory experience preferred (preferred).
Preferred Skills:
Exposure to Lean, Six Sigma, or other CI methodologies.
Familiarity with digital QA tools (e.g., Power BI, QMS platforms).
Understanding of equipment reliability and process capability concepts.
Multilingual capabilities are a plus.
Experience working across cultures and time zones.
Behavioral Expectations
Demonstrates ABS Values and behaviors in daily work.
Maintains professionalism in all communications.
Flexible and collaborative team member with a global mindset.
Actively participates in training and development opportunities.
Understands the business context and the role of quality in delivering customer value.
#LI-GL1
Business Overview
Genus is an agricultural biotechnology pioneer. We are a global FTSE 250 company, headquartered in the UK, and listed on the London Stock Exchange. Genus PLC has a presence in over 70 countries and a global workforce of over 3,000 employees and growing. We are a worldwide leader in porcine and bovine animal genetics, partnering with farmers to transform how we nourish the world - a mission that is important to a sustainable future.
ABS Global is a Genus company and is the world-leading provider of bovine genetics, reproductive services, technologies and udder care products. Marketing in more than 70 countries around the globe, ABS has been at the forefront of animal genetics and technology since its founding in 1941. We are uniquely positioned as a global player with a dedicated research and development function and an international distribution network. We breed and distribute the genes of the world's best bulls, scientifically selecting livestock whose offspring is designed to increase the profitability of our customers who are some of the world's biggest farmers and food producers. IntelliGen Technologies is the technology within ABS that develops sexed bovine genetics that helps customers maximize their profitability and reach their end goals in a fast and efficient manner.
Our vision is clear:
Pioneering animal genetic improvement to sustainably nourish the world.
Benefits Overview
US - At Genus, we offer a competitive salary. Benefits include health, dental, vision, FSA/HSA, long and short-term disability, 401K, tuition reimbursement, paid holidays and ETO (earned time off). This position will have opportunities for growth.
Equal Employment Opportunities
Genus is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Genus prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Genus conforms to the spirit as well as to the letter of all applicable laws and regulations.
Recruitment Fraud Warning
Genus plc will never ask you to provide fees or payment for computer, software, or other equipment or supplies during the recruitment and/or onboarding process. If you have any questions about your individual application, please contact the Genus Talent Acquisition team at ***********************.
Auto-ApplyDirector of Patient Safety & Quality (#3346)
Quality assurance manager job in Reedsburg, WI
Job DescriptionSalary:
RAMC is seeking a visionary and experienced individual to lead and advance our commitment to delivering safe, high-quality, patient-centered care!
Schedule: Monday through Friday
Hours per week: 40.0
Position Summary:
The Director of Patient Safety & Quality takes accountability for the planning, implementing, and monitoring activities related to clinical patient safety and aligns with the organizational mission, vision, and values. This individual accepts management responsibilities for the staff members employed in the roles of Infection Control Preventionist, RN-Data Analyst, RN-Patient Safety & Quality, Quality Specialist, Quality Assistant, and Medical Staff Specialist. This individual collaborates with the senior administrator responsible for risk management to integrate patient & quality activities. This individual collaborates with the Medical Staff Coordinator, to integrate provider peer review & quality activities.
Education and Training Required:
Graduation from an accredited School of nursing or academic equivalent;
Bachelor degree required (minimum);
Licensure as a Registered Nurse in the State of Wisconsin; OR
Registered Record Administrator;
Certification in Healthcare Quality Improvement (CPHQ) preferred.
Experience:
Minimum of two (2) years experience in patient safety and quality where performance improvement principles and concepts were utilized.
Minimum of one (1) year experience in peer review.
Good interpersonal skills, including knowledge of group dynamics and group processes, knowledge of adult learning principles, and the ability to interact with all levels of the organization, including the ability to influence and affect organizational change and transformation.
Possess strong analytical and organizational skills and have strong knowledge in the use of statistics, including the use of statistical tools and techniques.
Good working knowledge of computers and word processing.
Experience with Accountable Care Organization (ACO) preferred.
Special Knowledge, Skills, and Abilities:
Demonstrates knowledge of pertinent regulatory, accrediting, and advisory body requirements (i.e., Federal (CMS), The Joint Commission (TJC), etc.).
Demonstrates basic understanding of quality monitoring activities.
Project management skills with ability to organize and prioritize work activities.
Mathematical Skills: Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Demonstrates knowledge of statistical analysis.
Language skills: Ability to read, analyze, and interpret healthcare periodicals, professional journals, pertinent technical writings, and governmental regulations; ability to write reports, correspondence, and policies & protocols; and the ability to effectively present information and respond to inquiries.
Basic computer skills.
Ability to deal with and manage conflict and a diversity of opinions.
Ability to act with compassion, respect, prudent judgment and loyalty.
Ability to interact with others in an objective and positive manner.
Ability to function competently and effectively during periods of stress.
Ability to work independently.
Possesses general knowledge of growth and development theory and care of the patient across the life span in order to successfully educate and coach staff in appropriate and pertinent performance improvement activities.
Benefits:
RAMC offers an extensive benefits package to meet the needs of our employees and families.
We are committed to fostering a supportive and balanced work environment that encourages professional growth and personal well-being. Our focus on employee health and satisfaction is a cornerstone of our success.
Quality Manager
Quality assurance manager job in Darien, WI
Job Details WI Darien - Darien, WI Full Time $90000.00 - $110000.00 Salary/year 1st Shift QA - Quality ControlQuality Manager
Salary Range: $90k - $110k
Power Solutions International (PSI) is a leader in large gen-set packaging and enclosures. We provide turnkey, custom power packages that integrate alternators, cooling systems, controls, switchgear, cabling, and protection, delivered as containerized, skid, or walk-in solutions. Our team manages the full lifecycle from application engineering and 3D design to structural fabrication, wiring and piping, sound and thermal management, code compliance, factory acceptance testing, and site support. With scalable production capacity and disciplined program management, PSI delivers repeatable quality and reliable performance on complex builds for mission-critical and industrial applications worldwide.
Summary:
Under the direction of the Plant Manager the Quality Manager will be responsible for managing the Quality Department. In this role you will be part of the leadership team focused on supplying our customers with products that meet or exceed expectations. This position supports our Darien, WI and Beloit, WI facilities.
Responsibilities:
Planning, directing, and overseeing the operations of the Quality department
Maintains staff by interviewing, selecting, and training employees; maintaining and promoting a safe working environment; and developing personal growth opportunities for employees
Oversees and leads the work of employees within departments to ensure accurate and timeliness of work
Accomplishes staff results by communicating job expectations, coaching, and counseling employees, and enforcing company policies, procedures, and productivity standards
Train employees to read and follow drawings, specifications, and other instructions related to their role
Work with Engineering, Operations, and all supporting departments in developing and monitoring Control Plans for all products
Ensure ISO standards are established, maintained, and improve through proper procedures and internal auditing
Monitor Field Performance Data and drive corrective actions to prevent future occurrences and improve customer satisfaction
Develop Internal Quality Metrics for all areas and drive corrective measures to improve First Time Quality. The goal is to not make defects
Work with suppliers to ensure parts meet specifications
Supports resolution of Material Review Board Inventory
All other duties as assigned by management
Requirements:
Bachelor's degree in engineering or industrial/quality engineering. Consideration will be given to individuals who possess extensive Manufacturing and Quality experience.
Minimum 5 years of experience in Quality Management
Strong interpersonal skills with demonstrated ability to work with both direct reports and cross-functional groups
Knowledge of ISO-9001 required
Willingness to travel to suppliers as need (up to 10% domestically)
Root Cause analysis is a plus
Strong understanding of Statistics is desired
Knowledge in Lean Manufacturing and continuous improvement methods
PSI offers a wide range of benefits from medical, dental, and vision to pet insurance as well as discounted prescription plans. Additionally, we also provide a 401k match, life insurance and AD&D, short- and long-term disability, and an employee assistance program. Come join our team and learn more about PSI and what we have to offer!
Power Solutions International/3Pi is an EOE disability/vet company offering a drug-free workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Regional Quality Control Manager
Quality assurance manager job in Oconomowoc, WI
The County Materials Family of Companies manufactures and delivers concrete construction products to meet the demand for growing communities. We rely on our talented and dedicated team members to provide reliable products with personalized service. We are seeking a Regional Quality Control Manager for County Materials at Oconomowoc, WI.
Job Duties:
* Develop and implement quality management systems, policies, and procedures
* Oversee quality control at several locations to ensure adherence to established quality standards and promote a safety-first workplace
* Lead and mentor quality control team members to ensure compliance with company quality standards and industry specifications
* Analyze quality metrics and use findings to make data-driven decisions
* Track and report audit outcomes to ensure visibility and timely resolution
* Maintain documentation and certification compliance
* Serve as a communications liaison between plant operations, quality control, and external parties, such as industry associations and regulatory agencies.
Work Environment:
* Work in indoor and outdoor weather conditions, including extreme hot or cold temperatures.
* Work near moving machinery and equipment - could include electrical hazards.
* Work in a noisy environment
Physical Requirements:
* Carrying/Lifting 10 - 40 Pounds frequently
* Carrying/Lifting > 40 Pounds occasionally
* Sitting
* Standing / Walking / Climbing
* Squatting/Crouching/Kneeling/Bending
* Pushing / Pulling / Reaching Above Shoulder occasionally
Experience & Qualifications:
* Bachelor's degree in Quality Management, Engineering, Business Administration, or a related field.
* Minimum of 10 years of job-related experience. Must demonstrate in-depth knowledge of quality systems and possess strong analytical, communication, and leadership skills.
* Technology/Equipment: Highly proficient in Microsoft Office products and quality management software
Quality Assurance Specialist
Quality assurance manager job in DeForest, WI
ABS, Genus PLC has an exciting opportunity. We are looking for a Quality Assurance Specialist to support the ABS Operating System by executing and improving quality systems across ABS manufacturing sites.
This position is responsible for auditing, data analysis, training, and supporting continuous improvement initiatives aligned with Lean TPS principles. The specialist collaborates across regions to ensure consistent application of quality standards, drive root cause analysis, and embed a culture of first-pass quality and operational excellence.
This position is located in Wisconsin in the US and with international travel estimated at 10%.
The salary range for this position is $65,000 - 80,000 USD. The salary provided is a good faith estimate representative of all experience levels. Genus considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.
We would also consider employees working in other countries where Genus does business in LATAM, APAC and EMEA. Compensation and benefits would be aligned to that country.
You Will
Plan, execute, and oversee ABS operating system, process, and product audits to ensure adherence to standardized SOPs and quality requirements.
Maintain and improve global QMS functions such as Document Control, Change Control, and Auditing.
Track and investigate deviations, nonconformances, and customer complaints across regions, ensuring timely resolution and documentation.
Support harmonization of quality documentation and practices across global sites in alignment with the ABS Operating Model.
Collaborate with regional teams to ensure compliance with global quality system requirements and facilitate knowledge sharing.
Data Analysis & Reporting
Collect, interpret, and report production and quality data using statistical process control (SPC) and other analytical tools.
Monitor global quality KPIs and contribute to dashboards that support data-driven decision-making and continuous improvement.
Identify trends and systemic issues across sites, contributing to structured root cause analysis and corrective/preventive actions using tools such as A3, 5 Whys, and Fishbone diagrams.
Training & Capability Building
Develop and deliver global quality-related training on systems, policies, procedures, and core processes.
Collaborate with the Technical Training Manager and CI team to integrate Lean and quality principles into global training programs.
Provide coaching on risk assessment techniques and quality tools to cross-functional and cross-regional teams.
Collaboration & Continuous Improvement
Partner with Operations, R&D, Engineering, and CI teams globally to align quality efforts with business needs.
Participate in global Kaizen events, value stream mapping, and other CI activities to improve quality performance.
Support the deployment of Lean TPS principles and contribute to a culture of continuous improvement and operational excellence.
Other Duties
Comply with established global quality, safety, and environmental procedures and policies.
Perform other tasks as assigned by the Global CI & QA Manager.
Requirements
Demonstrates proficiency in application of QA system principles, concepts, industry practices, and standards and the interface with other functions like manufacturing, distribution, and maintenance.
Demonstrates strong verbal, technical writing, and interpersonal skills.
Knowledge of QA practices, theories, tools, and quality detection techniques
Experience in working with Microsoft Office, database software and QA applications
2+ years of relevant experience in a cGMP or an ISO-compliant environment (preferred).
Bachelor's degree in a scientific discipline with laboratory experience preferred (preferred).
Preferred Skills:
Exposure to Lean, Six Sigma, or other CI methodologies.
Familiarity with digital QA tools (e.g., Power BI, QMS platforms).
Understanding of equipment reliability and process capability concepts.
Multilingual capabilities are a plus.
Experience working across cultures and time zones.
Behavioral Expectations
Demonstrates ABS Values and behaviors in daily work.
Maintains professionalism in all communications.
Flexible and collaborative team member with a global mindset.
Actively participates in training and development opportunities.
Understands the business context and the role of quality in delivering customer value.
#LI-GL1
Business Overview
Genus is an agricultural biotechnology pioneer. We are a global FTSE 250 company, headquartered in the UK, and listed on the London Stock Exchange. Genus PLC has a presence in over 70 countries and a global workforce of over 3,000 employees and growing. We are a worldwide leader in porcine and bovine animal genetics, partnering with farmers to transform how we nourish the world - a mission that is important to a sustainable future.
ABS Global is a Genus company and is the world-leading provider of bovine genetics, reproductive services, technologies and udder care products. Marketing in more than 70 countries around the globe, ABS has been at the forefront of animal genetics and technology since its founding in 1941. We are uniquely positioned as a global player with a dedicated research and development function and an international distribution network. We breed and distribute the genes of the world's best bulls, scientifically selecting livestock whose offspring is designed to increase the profitability of our customers who are some of the world's biggest farmers and food producers. IntelliGen Technologies is the technology within ABS that develops sexed bovine genetics that helps customers maximize their profitability and reach their end goals in a fast and efficient manner.
Our vision is clear:
Pioneering animal genetic improvement to sustainably nourish the world.
Benefits Overview
US - At Genus, we offer a competitive salary. Benefits include health, dental, vision, FSA/HSA, long and short-term disability, 401K, tuition reimbursement, paid holidays and ETO (earned time off). This position will have opportunities for growth.
Equal Employment Opportunities
Genus is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Genus prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Genus conforms to the spirit as well as to the letter of all applicable laws and regulations.
Recruitment Fraud Warning
Genus plc will never ask you to provide fees or payment for computer, software, or other equipment or supplies during the recruitment and/or onboarding process. If you have any questions about your individual application, please contact the Genus Talent Acquisition team at ***********************.
Receive email notifications about our latest career opportunities, news and updates directly to your mailbox. Click here to sign up.
Auto-ApplySpecialist, Quality Assurance
Quality assurance manager job in Madison, WI
**_What Quality Assurance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
**_Job Summary_**
The Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. With basic knowledge of quality assurance concepts, the Specialist creates reports on quality metrics and trends in support of resolutions to quality issues and the development of standard operating procedures. The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities.
**_Responsibilities_**
+ Lead the efforts within Cardinal Health to collect substance information on products and raw materials from suppliers
+ Load and extract product systematic data on substances within Cardinal Health Master Data systems
+ Review and evaluate received questionnaire forms for completeness and applicability
+ Coordinate with Supplier, Sourcing, Quality, Regulatory and Manufacturing teams to obtain information necessary to complete assigned tasks
+ Identify and quantify risk, communicate results effectively to management
+ Support management of QRA policies governing product quality data
+ Identify quality and regulatory related issues within current processes, investigate and provide recommendations
+ Interact with cross-functional business partners (Customers, Operations, Sourcing, Regulatory, Manufacturing Quality, field QRA, etc.) to assist in execution of the current Medical Distribution Quality Plan.
+ Responsible for deployment of policies and programs to minimize risk and enable compliant business operations for Cardinal Health
+ Demonstrates working knowledge of applicable laws and regulatory concepts utilized to manage risk
+ Supports development of programs, policies and procedures using knowledge of regulatory requirements and technologies
+ Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces
+ Proactively develops and maintains a broad knowledge of the technical disciplines in own functional area; applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results
+ Uses deep subject matter/functional expertise; influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications
+ Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources
+ Champions and leads change initiatives; identifies the best approach for implementing strategic processes; in light of culture and diversity
**_Qualifications_**
+ Bachelor's degree preferred
+ 1-3 years experience preferred
+ Knowledge of Regulated Substances regulations such as EU MDR, REACH, RoHS, WEE, POP and California Proposition 65 preferred
+ Distribution Operations processes (Medical and Pharmaceutical) preferred
+ Excellent verbal, written, computer, SAP, and interpersonal skills required
+ Excellent influencing skills
+ Must be able to multitask and work with competing priorities
**_What is expected of you and others at this level_**
+ Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces
+ Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results
+ Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications
+ Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources
+ Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity implications
**Anticipated hourly range:** $26.90 per hour - $36.90 per hour
**Bonus eligible:** No
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with my FlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 12/07/2025 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (***************************************************************************************************************************
Quality Control Manager
Quality assurance manager job in Beloit, WI
Production Quality Manager Travel: ~5% Join a leader in industrial engine manufacturing supporting U.S. defense programs.Fairbanks Morse Defense is seeking a Production Quality Manager to ensure products meet strict regulatory and customer standards, especially in defense and DoD-related projects.
What You'll Do
Ensure compliance with ISO 9001, contract requirements, and safety standards
Drive process improvements and inspection efficiency
Develop and manage Control Plans for new engine programs
Conduct internal audits and ensure procedural compliance
Train QC staff and implement Standard Work
Investigate root causes of quality issues and drive corrective actions
Manage customer and third-party inspections
What We're Looking For
Bachelor's degree in engineering
5+ years in quality or process roles (manufacturing, shipyard, construction, or defense)
Experience with DoD contracts highly preferred
Familiarity with diesel engines and heavy industrial fabrication
Knowledge of ISO 9001, process control, and GD&T
Strong leadership, organization, and communication skills
Proficient with Microsoft Office and QA/QC management tools
U.S. Citizenship required (NOFORN compliance-no dual citizenship)
Why Join Us
Make a direct impact on U.S. Navy and defense projects
Work in a collaborative, technically skilled team
Competitive pay and benefits
Opportunities for career growth and training
Note: This position requires access to Unclassified Naval Nuclear Propulsion Information and is limited to U.S. citizens only (no dual citizenship). You must be able to obtain and maintain a DoD security clearance.
Apply now to help us deliver mission-critical quality and performance.
Quality Control Manager - Beloit WI
Quality assurance manager job in Beloit, WI
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers
. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.
Travel: ~5%
Join a leader in industrial engine manufacturing supporting U.S. defense programs.
Fairbanks Morse Defense is seeking a Quality Control Manager to ensure products meet strict regulatory and customer standards, especially in defense and DoD-related projects.
What You'll Do
Ensure compliance with ISO 9001, contract requirements, and safety standards
Drive process improvements and inspection efficiency
Develop and manage Control Plans for new engine programs
Conduct internal audits and ensure procedural compliance
Train QC staff and implement Standard Work
Investigate root causes of quality issues and drive corrective actions
Manage customer and third-party inspections
Additional Qualifications/Responsibilities
What We're Looking For
Bachelor's degree in engineering
5+ years in quality or process roles (manufacturing, shipyard, construction, or defense)
Experience with DoD contracts highly preferred
Familiarity with diesel engines and heavy industrial fabrication
Knowledge of ISO 9001, process control, and GD&T
Strong leadership, organization, and communication skills
Proficient with Microsoft Office and QA/QC management tools
U.S. Citizenship required (NOFORN compliance-no dual citizenship)
Why Join Us
Make a direct impact on U.S. Navy and defense projects
Work in a collaborative, technically skilled team
Competitive pay and benefits
Opportunities for career growth and training
Note: This position requires access to Unclassified Naval Nuclear Propulsion Information and is limited to U.S. citizens only (no dual citizenship). You must be able to obtain and maintain a DoD security clearance.
Director of Quality Assurance & Regulatory Affairs (QA/RA)
Quality assurance manager job in Madison, WI
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.