Quality assurance manager jobs in Janesville, WI - 165 jobs

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position 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 Wisconsin pay range $130,000-$150,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

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.

Job DescriptionQuality Director Supervisor: General Manager / Executive Management Primary Location: Ad-Tech Industries - Watertown, WI The Quality Director is responsible for leading and managing all quality-related programs to ensure that the customer is always the first priority. This role ensures that all products, services, and processes meet or exceed customer, regulatory, and internal quality standards. The Quality Director works closely with management and employees at all levels to promote a culture of quality, accountability, and continuous improvement throughout the organization. Compensation Compensation is competitive and based on experience, qualifications, and overall fit for the role. Skills, Knowledge, and Abilities Ability to read, analyze, and interpret complex quality documents, specifications, procedures, and regulatory requirements. Ability to respond effectively to sensitive customer inquiries, complaints, and quality concerns. Strong reasoning ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to calculate figures such as percentages, proportions, area, volume, and apply basic algebra and geometry concepts. Excellent written and verbal communication skills with the ability to make presentations to management, customers, and external organizations. Proficient computer skills, including Microsoft Word and Excel, for report writing, data analysis, and spreadsheet maintenance. Ability to manage multiple priorities while maintaining a high level of attention to detail. Ability to communicate professionally with customers, employees, and management. Education and Training High school diploma required. Associate's degree in General Business, Quality, or a related field preferred, or a minimum of five (5) years of equivalent experience in a related field. Bachelor's degree in Business or a related field preferred. Ability to work directly with all members of management and the workforce. Demonstrated ability to conduct audits, investigations, and inspections to ensure compliance with company quality programs and procedures. Ability to represent the company in quality-related meetings with customers, vendors, and external organizations. Essential Responsibilities Develop, implement, and maintain quality systems, policies, and procedures. Lead internal audits, investigations, and corrective actions to ensure compliance with quality standards. Monitor and analyze quality data to identify trends and drive continuous improvement initiatives. Address customer complaints and quality concerns promptly and professionally. Prepare and present quality reports to management as required. Ensure employees understand and support quality expectations and customer requirements. Coordinate with operations, engineering, and management to resolve quality issues. Represent the company in customer audits, quality meetings, and external quality-related activities. Ensure all quality activities align with company goals, customer requirements, and regulatory standards. Work Environment & Physical Demands Combination of office and production floor work. Frequent walking or standing on concrete surfaces. Physical activity includes sitting, standing, walking, bending, reaching, grasping, twisting, and turning. Exposure to varying temperatures and moderate noise levels on the production floor. Requires the ability to see, hear, and communicate clearly in English. Must wear required personal protective equipment (PPE) while on the production floor. Work schedule may range from 8-12 hours per day, including early or late meetings. Subject to random drug and/or alcohol testing. Additional Responsibilities Maintain a professional appearance and demeanor at all times. Support company policies, procedures, and safety programs. Demonstrate a commitment to quality, customer satisfaction, and continuous improvement. Travel as required to support quality initiatives; must be able to legally operate a motor vehicle in all weather conditions.

Quality Manager 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

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.

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: **************************

Title Quality Assurance Manager jOB # JD-074 Date November 12, 2024 FLSA Exempt LOCATION Lake Bluff and McHenry, IL REPORTS TO Vice President of Operations POSITION SUMMARY This position is Jessup Manufacturing's “Champion of Quality”. Manages enterprise wide QMS including ISO 9001 and any future quality or environmental standards. Leads continuous improvement efforts focused on prevention to improve quality and profitability. RESPONSIBILITIES Manages Quality Assurance Technicians to support enterprise-wide production functions. Manages all phases of ISO 9001 Quality Management System (QMS) including documentation, implementation, audits and management review. Uses Key Process Indicators (KPI”S) and internal audits to prioritize areas for improvement through Root Cause Analysis and Permanent Corrective Actions. Tracks and reports Quality KPIs Represents, maintains, and coordinates documentation and audits for 3 rd party certifications (UL, MED, FM, NEMO) Develops and implements employee training to achieve quality improvement goals. Supports Product Development and Manufacturing to develop, communicate, and maintain product and manufacturing specifications. Teams with sales and customer support to ensure customer inquiries regarding product performance and tolerances are answered accurately and promptly. Owns the Customer Complaint process including validation, reporting and resolution. This will include direct contact with Sales, Manufacturing, suppliers and customers. Develops and maintains all testing, documentation, and quality procedures for incoming, in process and final inspection. Drives Nonconforming Material process at all levels of manufacturing. Drives incoming non-conforming material process including documentation, containment, Supplier Corrective Action and verification of effectiveness. Coordinates RMA's and debit memos for produced and purchased materials. Leads Material Review Board (MRB) to disposition all quarantined and returned materials. Maintains all Corrective Action Records (CAR's). Oversees evaluation and implementation of CAR's, and monitors CAR's effectiveness. Completes control plans, PPAP, FMEA, FAI and gauge R&R as required. Implements supplier incoming quality requirements. Manages test equipment control and calibration processes. Owns Jessup Manufacturing's Environmental Health and Safety (EHS) program. Lead Safety Committee meetings. Represent Jessup for OSHA or related visits and coordinate response to OSHA inspections and findings. Manage safety audits. Document, maintain, and implement safety policies. Coordinate required safety training, including new employee, recurring training, and introducing new topics. Makes suggestions to improve quality, efficiency, safety, and communication, and encourages all employees to do the same. Travels between production facilities as expected. Limited travel to suppliers, outside service providers and customers will be expected. Other Duties as required. EDUCATION & EXPERIENCE Bachelor's degree in chemistry, engineering, or equivalent. Minimum of 3 - 10 years' experience in managing multi-plant ISO Certified Quality Systems. Proven leadership of Lean Manufacturing / Continuous improvement initiatives. Background in PSA coating, converting and printing preferred. Management of EHS systems preferred. SKILLS Ability to manage cross-functional teams to effectively bring solutions to quality issues. Strong problem-solving skills. Knowledge of quality reporting and techniques including SPC, PPAP, FMEA, FAI and Gauge R&R. Excellent presentation, verbal and written communications skills. Excellent analytical, organizational and computer skills.

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.

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

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

Job ID 45321 Date 16 January 2026 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

Qualifications Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Manager Quality Assurance. Responsible for organizing on-site quality supervision, managing quality-related investigations and CAPA execution, and organizing batch record review and product release activities. Ensure that production operations and related quality activities comply with GMP and company quality standards, safeguard product quality and compliance, and drive continuous improvement of the quality system and team capability. Essential Responsibilities On-Site Quality Oversight Plan, organize, and oversee on-site quality supervision activities to ensure GMP compliance and effective execution of procedures. Review and approve quality supervision documentation, ensuring timely identification, escalation, and resolution of quality issues. Review and assess original GMP records, including deviation investigations, change controls, and equipment malfunction documentation. Oversee and authorize in-process control (IPC) release activities in accordance with approved procedures. Quality Investigations and CAPA Management Establish, organize, and maintain compliant processes for quality investigations and CAPA execution. Provide technical oversight, guidance, and review of deviation and customer complaint investigations conducted by investigators. Ensure investigations and CAPAs are completed on time, thoroughly documented, and effectively closed. Monitor and track CAPA implementation and effectiveness to drive continuous improvement of the quality system. Batch Record Review and Product Release Establish and maintain procedures governing batch record review and product disposition. Ensure timely and thorough review of batch production and testing records, with prompt resolution of discrepancies. Organize and oversee product release activities, ensuring compliance with regulatory requirements while maintaining operational efficiency. Cross-Functional Quality Leadership Act as a primary Quality interface with Operations, Quality Control, and Engineering functions. Facilitate cross-functional resolution of quality issues and provide GMP guidance to support operations. Report quality metrics, deviation and CAPA trends, and improvement initiatives to management. Provide quality and compliance input for cross-functional projects and process improvement initiatives. Team Leadership and Resource Management Lead and manage on-site QA and Operations On-Site QA teams, defining roles, responsibilities, and performance expectations. Coach and develop team members to strengthen competencies in investigations, CAPA management, and GMP documentation. Assess workload and resource needs, adjusting staffing and priorities to ensure business and compliance requirements are met. Additional Responsibilities Audit and Inspection Support Support internal and external audits and regulatory inspections. Ensure timely development, implementation, and closure of corrective actions arising from audit and inspection findings. Job Requirements and Qualifications: Education: Required: Bachelor's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields. Preferred: Master's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields Experience: Required: 5 plus years, minimum of 2 years in management. Preferred: 10+ years, minimum of 2 years in management. WHY JOIN SPL? Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential. Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!

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

The Quality Manager position develops, implements, and manages quality control systems designed to ensure continuous production of applications (consistent with established standards, customer specifications and production goals). The position supervises a team of quality engineers, quality control inspectors, and sorting department. Quality Manger aims to ensure that the organization & Quality Management System conforms to customer, internal, IATF 16949 and regulatory/legal requirements. Manage Sorting Department including working staffing plan, tracking daily production and quality issues. Essential Duties and Responsibilities The essential functions include, but are not limited to the following: - Understanding customer needs and requirements to develop effective quality control processes. - Devising and reviewing specifications for products or processes. Assist in setting requirements for raw material or intermediate products for suppliers and monitoring their compliance. - Engage in inspection and testing activities to ensure high productivity and high technical integrity. - Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished products. - Formulate, document, and maintain quality control standards and on-going quality control objectives. - Coordinate objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs. - Apply total quality management tools and approaches to analytical and reporting processes - Maintain active role on internal continuous improvement teams. - Design, develop and implement quality control training programs. - Corrective and preventive action (CAPA, also called corrective action / preventive action, or simply corrective action) are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. - MPR - Minimum process Requirements is the process of documenting, analyzing, tracing, prioritizing and agreeing on requirements and then controlling change and communicating. It is a continuous process throughout a project. - Root Cause Analysis (RCA) is a set of analyzing and problem-solving techniques targeted at identifying the actual root cause or the reason that caused the problem. - Interact with vendors to ensure quality of all purchased parts. - Assist in process certification -Schedule production (Manpower and machine selection taking vacation into account) -Inventory control (lasers, cameras, fixtures, etc…) -Sign off on weekly, monthly and yearly check sheets -Track daily quality issues found by sort machines -Track daily production targets -Annual review & control for each sorting associate Minimum Qualifications (Knowledge, Skills, and Abilities) - Associate Degree or 10 years progressive experience in a Fastener industry - Must have knowledge in the automotive industry - Experience with production control - Minimum Process Requirements (MPR) - Corrective and Preventative Action (CAPA) - Root Cause Analysis (RCA) - 4+ years leadership experience or leadership development training - Reliable and good work ethic - Remain calm in stressful situations - Demonstrates effective oral communication - IATF 16949 auditor (preferred) - Intermediate level Microsoft Office Suite knowledge - Prioritize, organize, and accomplish work efficiently - Move quickly from task to task with minimal errors and/or omissions - Always follow all OSHA and company safety guidelines - PLEX UX knowledge - OSHA Training (preferred) - Problem solving and decision-making training (preferred) Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. - Ability to lift up to 40 pounds. - Must wear Personal Protective Equipment (PPE) which is required in designated areas. - Ability to continuously stand and move through 8-10-hour shifts - Ability to travel up to 10% of the time with some out -of-area and overnight stays. (Audit etc.) You should be proficient in: Blueprint Reading, Quality Inspection Experience, Machines & technologies. You'll use: ERP Software, and Quality Control Software Note This job description in no way states or implies that these are the only duties to be performed by the employee(s) of this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the employee(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an at will relationship.

Job DescriptionThe Quality Manager is responsible for overseeing all aspects of product quality, inspection, documentation, and compliance within our manufacturing environment. This is a hands-on role requiring extensive involvement in daily inspection activities, PPAP documentation, gage management, corrective actions, and calibration systems. The ideal candidate has experience in fastener or screw manufacturing and understands the unique requirements of cold heading, secondary operations, and customer-specific standards.Key Responsibilities:Quality Control & Inspection Perform and oversee hands-on dimensional and visual inspections using micrometers, calipers, ring gages, pin gages, optical comparators, and other measurement tools. Maintain inspection records, lot traceability, and required documentation. Train and guide operators on basic inspection methods and quality expectations. Quality Management System Lead corrective action processes (8D, root cause analysis, containment, verification). Maintain and improve quality procedures, work instructions, and internal audit processes. Manage customer complaints, non-conformances, and internal quality alerts. PPAP & Documentation Prepare and submit PPAP packages including FMEAs, control plans, process flows, capability data, and submission documentation. Work directly with customers on quality requirements, approvals, and ongoing performance metrics. Gage & Calibration Management Oversee all gage calibration activities and maintain calibration records. Maintain gage R&R studies and ensure appropriate measurement controls. Manage gage inventory, replacement schedules, and certification tracking. Leadership & Collaboration Work closely with production, engineering, and shipping to ensure adherence to quality standards. Lead quality-related meetings and drive continuous improvement initiatives. Support training and development of inspection staff and operators. Requirements: Experience in fastener, screw, or precision component manufacturing (REQUIRED). Strong hands-on inspection skills and familiarity with common measurement tools. Working knowledge of PPAP, APQP, FMEA, control plans, and capability studies. Experience with gage calibration management and gage R&R. Ability to lead root cause analysis and implement corrective actions. Strong documentation and organizational skills. Ability to work independently and manage multiple priorities. No degree required; relevant experience in fastener manufacturing is essential. What We Offer: Stable Monday-Friday schedule Small-team environment where your impact is seen daily Opportunity to modernize quality processes and lead change Long-term growth potential as the company expands Benefits: medical, dental, PTO and more. For more details, please call Melissa @ 815-997-1442 or email at: melissa.saunders@furstpros.com #FPTECH

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!

We're looking for a Remote Quality Assurance Coordinator to join our team! The Quality Assurance Coordinator is responsible to ensure reports are completed at the highest level of quality and integrity and in full compliance with client contractual agreement, regulatory agency standards and/or federal and state mandates. This position is required to handle quality assurance questions and provide overall support to the Quality Assurance Department. The schedule is Monday to Friday 10:00am to 6:30pm CT (with occasional weekend coverage). ESSENTIAL JOB FUNCTIONS Perform quality assurance review of reports, correspondences, addendums or supplemental reviews. Ensure clear, concise, evidence-based rationales have been provided in support of all recommendations and/or determinations. Ensure that all client instructions and specifications have been followed and that all questions have been addressed. Ensure each review is supported by clinical citations and references when applicable and verifies that all references cited are current and obtained from reputable medical journals and/or publications. Ensure the content, format, and professional appearance of the reports are of the highest quality and in compliance with company standards. Ensure that the appropriate board specialty has reviewed the case in compliance with client specifications and/or state mandates and is documented accurately on the case report. Verify that the peer reviewer has attested to only the facts and that no evidence of reviewer conflict of interest exists. Ensure the provider credentials and signature are adhered to the final report. Identify any inconsistencies within the report and contact the Provider to obtain clarification, modification or correction as needed. Assist in resolution of customer complaints and quality assurance issues as needed. Ensure all federal ERISA and/or state mandates are adhered to at all times. Provide insight and direction to management on consultant quality, availability and compliance with all company policies and procedures and client specifications. Promote effective and efficient utilization of company resources. Participate in various educational and or training activities as required. Perform other duties as assigned. Qualifications Education and/or Experience High school diploma or equivalent required. Two years IME or medical experience preferred. Knowledge of the insurance industry preferably claims management relative to one or more of the following categories: workers' compensation, no-fault, liability, and/or disability preferred. QUALIFICATIONS Must have strong knowledge of medical terminology, anatomy and physiology, medications and laboratory values. Must be able to add, subtract, multiply, and divide in all units of measure, using whole numbers and decimals; Ability to compute rates and percentages. Must be a qualified typist with a minimum of 40 W.P.M preferred. Must be able to operate a general computer, fax, copier, scanner, and telephone. Must be knowledgeable of multiple software programs, including but not limited to Microsoft Word, Outlook, Excel, and the Internet. Must possess excellent skills in English usage, grammar, punctuation and style. Ability to follow instructions and respond to upper managements' directions accurately. Must demonstrate accuracy and thoroughness. Look for ways to improve and promote quality and monitors own work to ensure quality is met. Must demonstrate exceptional communication skills by conveying necessary information accurately, listening effectively and asking questions where clarification is needed. Must be able to work independently, prioritize work activities and use time efficiently. Must be able to maintain confidentiality. Must be able to demonstrate and promote a positive team -oriented environment. Must be able to stay focused and concentrate under normal or heavy distractions. Must be able to work well under pressure and or stressful conditions and must possess the ability to manage change, delays, or unexpected events appropriately. Ability to follow all company policies and procedures in effect at time of hire and as they may change or be added from time to time. ExamWorks is a leading provider of innovative healthcare services including independent medical examinations, peer reviews, bill reviews, Medicare compliance, case management, record retrieval, document management and related services. Our clients include property and casualty insurance carriers, law firms, third-party claim administrators and government agencies that use independent services to confirm the veracity of claims by sick or injured individuals under automotive, disability, liability and workers' compensation insurance coverages. ExamWorks offers a fast-paced team atmosphere with competitive benefits, paid time off, and 401k. ExamWorks, LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. Equal Opportunity Employer - Minorities/Females/Disabled/Veterans

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