Quality System Specialist/IATF-16949 Lead Auditor
6AM City, LLC
Job Description Job Title: Quality System & QC Laboratory Specialist Department: Quality Reports To: Quality Manager Direct Reports: None Status: Exempt Shift: Day Shift Job Summary The Quality System & QC Laboratory Specialist is responsible for implementing, maintaining, overseeing, controlling, and keeping up to date all records and processes documentation of the company’s Quality Management System (QMS) to ensure company certification, and compliance with ISO9001 and IATF16949 standards. This position is also responsible for overseeing the Quality Control (QC) Laboratory regarding calibration, dimensional scanning and dimensional compliance of products. Main Duties and Responsibilities Implement and maintain the document processes, document control, record keeping system, and documents used by all departments that are required by the company Quality Management System to ensure full compliance with ISO‑9001 and IATF‑16949 standards. This includes establishing and maintaining a process and controls to ensure documents are timely reviewed, updated, approved, distributed and filed whenever changes occur. Assist Quality Manager to schedule, coordinate, and conduct internal and external audits as required by the ISO‑9001 and IATF‑16949 standards, including training record keeping and maintaining up to date certification documentation of internal auditors. Manage all record keeping of the Corrective/Preventive Actions process including documentation related to closure actions of CAPAs in response to internal and external audit findings, customer issues, and overall system weaknesses. Provide support to Plant Managers coordinating regular audits to ensure compliance by departments to established processes/procedures and respective training to employees has taken place to comply with IATF‑16949 standards. Manage and maintain all calibrated equipment to ensure they are operating correctly and get re‑certified on time per SOP‑QLTY‑007 (Calibration and Gage Management) procedure. Manage and lead all 3D scanning projects as needed. Provide 3D scanning training to develop additional resources for this activity. Perform other duties as assigned. Requirements Education Bachelor's degree in engineering, business, or related field. Experience Minimum of 3‑5 years’ experience with Quality Management Systems (QMS), GD&T, ISO 9001 and/or IATF16949 required. Certificates, Licenses, Registrations IATF‑16949 Lead Auditor Certification Computer Skills Intermediate to advanced proficiency in MS Office, including Word, Excel, PowerPoint, Teams and in the use of e‑mail and web browser applications. Experience with 3D scanning software (Polyworks) desired. Mathematical Abilities Intermediate‑advanced math skills. Analytical or Reasoning Abilities Strong analytical, planning skills and critical thinking ability required with orientation for continuous improvement. Ability to understand and follow written technical procedures/instructions. Ability to effectively prepare business and technical documentation such as procedures, reports, presentations, etc. Communication Skills: (Writing, Foreign Language, Reasoning) Ability to read, write and speak English. Highly effective, articulate communication skills (verbal & written) with strong interpersonal effectiveness and the ability to work with all levels in the organization and across cultures. Bilingual English‑Spanish preferred. Other Skills (Technical, or Other special knowledge and abilities) Ability to effectively organize and prioritize work. Strong attention to detail and ability to effectively manage a variety of projects and tasks. Take initiative, approach others in a positive and constructive manner, and work well independently to achieve results. Physical Requirements About 50% of the time will be spent doing desk related work on a computer and working with basic office equipment (PC, fax and printer, phones) while the remaining time will be spent on the production floor completing work related to the position. Must be able to lift 25 pounds individually and team lift 50 pounds. Must be able to perform this job safely in accordance with standard operating procedures without endangering the health or safety of self or others. Must wear all personal protective equipment where required. Internal Applicants Must Be outside of their 90‑day probationary period and have 6 months in their current role. Have no active Step 2 or higher on file (attendance or otherwise). Benefits Annual bonus 5% Paid Basic life insurance Paid Short‑term disability Paid time off Paid 2 shutdown work weeks (summer and winter) 401(k) 401(k) matching (discretionary) Dental insurance Health insurance Vision insurance Flexible spending account Health savings account Referral program #J-18808-Ljbffr 6AM City, LLC
- 6AM City, LLC in Wisconsin is seeking a Quality System & QC Laboratory Specialist to maintain the Quality Management System (QMS) and ensure compliance with ISO9001 and IATF16949 standards. The role involves overseeing the Quality Control Laboratory and managing documentation...Suggested
$80k - $102k
...Lead Auditor - GMP Quality Audits will perform high level assessments of quality systems in a variety of manufacturing sites, farms, processing plants and/or other work related sites throughout a region or country. Assess and report in accordance with UL, industry...SuggestedFull timeTraineeshipWork experience placementWork at officeRemote work- ...UL, LLC is seeking a Lead Auditor for GMP Quality Audits to assess quality systems in various manufacturing sites across the United States. The role demands strong analytical skills, leadership abilities, and the capability to communicate effectively with high executives...SuggestedRemote work
$26 per hour
...Quality Systems Specialist Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of...SuggestedHourly payWork at office- ...Quality Systems Specialist The Quality Systems Specialist is responsible for ensuring that the company's food safety and quality management Pre-requisite systems meet SQF standards and maintain SQF certification. This role involves monitoring food safety plans and...SuggestedWork at officeLocal areaFlexible hoursShift workNight shiftAfternoon shift
$52k - $80k
...Job Title: Quality Systems Specialist – CAPAs and DeviationsJob Description The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, with a primary focus on managing corrective and preventive actions...Permanent employmentTemporary workWork at officeMonday to FridayFlexible hoursDay shift$27.69 - $31.01 per hour
...shape what's next. JOB SUMMARY TekniPlex is hiring a Quality Systems Specialist for our Madison, WI facility. A team leader, planner, trainer... ...preparation, execution, and follow-up on audit findings Lead and/or support Corrective and Preventive Actions (CAPA),...Hourly payDaily paidTemporary workWork experience placementLocal areaFlexible hours- ...Purpose and Function: Independently perform quality-related functions within the Quality Department. Maintain and monitor quality systems, including document control, change... ...cycle of customer complaints and CAPA’s · Lead internal audit program · Assist in the development...
- ...discovered something special. A company that cares. Cares about leading the way in construction, engineering, manufacturing and... ...of team members through our Culture of Care Our Financial Systems Analyst is responsible for the administration, maintenance, and...Full timeMonday to FridayFlexible hours
$88k - $132k
...ABOUT THE ROLE The Senior Financial Systems Analyst serves as the end-to-end process... ...partners closely with IT to ensure data quality, integrity, and seamless integration across... ...Requirements WHO WE ARE Relativity is a leading legal data intelligence company building...Remote workHome office$75k
...Production Supervisor – (Food Manufacturing, Team Leadership & Quality Systems) Up to $75,000 + Saturday Premiums & Bonus • Jefferson, WI... ...manufacturer known for treating employees exceptionally well Lead a high-performing production team in a safety-first environment...Work at officeShift workAfternoon shift- ...Mercyhealth System is seeking Family Medicine Program Director to lead our recently established rural residency team in Lake Geneva, Wisconsin! Mercyhealth... ...adherence with ACGME requirements. - Oversee the quality of education, curricula, and experiential rotations...Temporary workLocal areaRelocation package
- Ryder System, Inc. seeks a Procurement Systems Specialist in Madison, WI to provide operational and analytical support for P2P and Vendor Management platforms. The role involves analyzing workflows, administering BPO programs, and participating in system enhancements. Qualified...
$86 - $93 per hour
...Financial Systems Readiness & Adoption Lead Location: Hybrid (Milwaukee, WI – up to 3 days per week onsite) Engagement Type: Full-time Step into a high-impact financial transformation Trissential is partnering with a mission-driven, highly regulated organization...Hourly payFull time3 days per week- Job Description Summary Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launches, premarket submissions/registrations, and postmarket compliance, working closely with global healthcare regulatory...Immediate startVisa sponsorshipWork visaRelocation package
$80k - $200k
...A leading life sciences software company is seeking a Senior Consultant with expertise in regulatory information management. This remote... ...over 8 years of experience in life sciences, direct technology system implementation, and a proven track record of managing diverse...Remote work- ...Quality Systems Seasonal Lead Joining Nortera means choosing opportunities to grow together! As North America's leader in ready-to-cook vegetables, we are committed to contributing to the well-being of society by providing access to healthy and sustainable food....Weekly paySeasonal workShift work
- ...organization is a multi-state, integrated healthcare system that includes seven hospitals, featuring a... ...compliance with ACGME standards: Oversee the quality of education, curricula, and experiential rotations. Lead the interview, selection, and evaluation processes...Temporary workLocal areaRelocation package
- ...values its culture and people as its biggest strengths. Come join us as a Quality Systems (Veeva) Senior Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries....RelocationHome office
- A leading healthcare technology company in Menomonee Falls, Wisconsin, is seeking a CRM & Systems Integration Specialist. This role involves designing, managing, and enhancing marketing and... ...will lead projects to improve data quality and customer experience through strategic...
- MGS Manufacturing is seeking a Quality Systems and Compliance Manager to ensure effective management of corporate quality systems across all manufacturing locations. You will support the Director of Quality Systems & Compliance in enhancing operational efficiency, quality...
$133.5k - $186.4k
...help shape the future of one of the world’s leading live service franchises. Respawn... ...looking for a passionate and experienced Lead Systems Designer to shape and evolve the player... ...while advocating for player-first, high-quality experiences Qualifications ~10...Full timeLocal area- Job Summary: Under the direction of the Material Systems Supervisor, the Lead Material System Technician will oversee the department and is responsible... .... This will be achieved by maintaining HellermannTyton's Quality and EMS certifications by supporting all corporate...Local areaShift workWeekend work
- HC1316 GE Precision Healthcare LLC is seeking a Lead MR Applications & System Tools Engineer to innovate in Magnetic Resonance imaging technology. In this role, you will design and develop software tools that enhance MR system calibration and diagnostics, working alongside...
- ...operational requirements in a complex environment. The successful applicant will engage with engineering leads to validate integration efforts of foreign systems. Candidates must demonstrate 8-10 years of relevant experience along with an active TS/SCI clearance. Strong...
$110k - $120k
twiceasnice Recruiting is seeking a Senior CRM & Business Systems Manager for a mission-driven nonprofit in North Dallas, TX. This hybrid role involves leading CRM initiatives, overseeing data management, and optimizing business systems. The ideal candidate has over 5 years...- An established industry player is seeking a Senior System Admin Specialist Advisor to enhance their mainframe DB2 support. This role offers the opportunity to engage in high-impact projects, collaborate with partners, and contribute to significant improvements in system...Remote job
- Eaton Corporation is looking for a Technical Program Manager in the Town of Caledonia, Wisconsin, to lead new product development within the Power System Division. This role involves guiding the development of software and embedded systems using best practices and ensuring...
- ...Job Description: The Lead Systems Designer leads a couple of cross-functional program teams (7T Program and 3T MAGNUS (Head Only Scanner... ...the technical content, performance, intellectual property, and quality deliverables of an NPI and Research programs. The position has...Immediate start
- ...) to develop the next generation of Ultrasound Systems in the General Imaging and Primary Care product lines. The Lead System Designer plays a critical role in the design... ...workflow, feature functionality, product quality, reliability, serviceability, manufacturability...Work experience placementVisa sponsorshipWork visaRelocation package
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality System Specialist/IATF-16949 Lead Auditor. Be the first to apply!
- warehouse quality control associate Wisconsin
- quality associate Wisconsin
- quality auditor Wisconsin
- quality assurance auditor Wisconsin
- quality specialist Wisconsin
- quality control associate Wisconsin
- quality review specialist Wisconsin
- quality management specialist Wisconsin
- safety auditor Wisconsin
- medical claims auditor Wisconsin


