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Qms Jobs in Indiana (NOW HIRING)

Detroit Engineered Products

Plant QMS/PMT Engineer

Warsaw, IN · On-site

$69K - $89K/yr

Coordinate the requirements, user feedback, and best practices for our QMS and QOS systems, ensuring that they meet the needs and expectations of the internal and external stakeholders. * Collaborate ...

eShocan

Plant QMS/PMT Engineer

Warsaw, IN · On-site

$60K - $78K/yr

Coordinate the requirements, user feedback, and best practices for our QMS and QOS systems, ensuring that they meet the needs and expectations of the internal and external stakeholders. * Collaborate ...

Recar

CI-Q Excellence Group Leader

Warsaw, IN

Lead a team of experts in Q-Excellence, QMS, QOS, and PMT for quality systems development, integration and rollout for Slate, aligning with the business objectives and priorities. * Lead the team for ...

Slate Auto

CI-Q Excellence Group Leader

Warsaw, IN · On-site

Lead a team of experts in Q-Excellence, QMS, QOS, and PMT for quality systems development, integration and rollout for Slate, aligning with the business objectives and priorities. * Lead the team for ...

D&H

Quality and Training Specialist

Whiteland, IN · On-site

Summary The Quality and Training Specialist supports the organization'sQuality Management System (QMS) to ensure compliance with ISO standards,applicable AIB (American Institute of Baking) food ...

Recar

CI-Q- Accademy, Q Excellence Lead

Warsaw, IN

Serve as a CI and Q-Excellence subject matter expert supporting QMS, QOS, and PMT deployment and sustainment across the plant * Support the development, integration, rollout, and continuous ...

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$33.7K

$114.1K

$173.1K

How much do qms jobs pay per year?

As of Jul 8, 2026, the average yearly pay for qms in Indiana is $114,103.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,400.00 and $150,500.00 per year, depending on experience, location, and employer.

What is the difference between Qms vs Quality Assurance Specialist?

AspectQmsQuality Assurance Specialist
CertificationsISO 9001 Lead Auditor, Quality Management certificationsISO 9001, Six Sigma, CQE
Work EnvironmentManufacturing, industrial, or service sectors focusing on quality systemsManufacturing, software, healthcare, and various industries
Employer & Industry UsageOrganizations implementing quality management systemsCompanies ensuring product/service quality
Search & Comparison IntentUnderstanding quality system implementationQuality process evaluation and improvement

Qms professionals focus on establishing, maintaining, and auditing quality management systems within organizations, often working with standards like ISO 9001. Quality Assurance Specialists concentrate on testing, inspection, and ensuring products or services meet quality standards. While both roles aim to improve quality, Qms roles are more system-oriented, whereas Quality Assurance Specialists are more product-focused.

What is the work of QMS?

A Quality Management System (QMS) professional is responsible for developing, implementing, and maintaining quality standards and procedures within an organization. They ensure products and services meet regulatory requirements and customer expectations, often using tools like audits and process improvements. Strong attention to detail and knowledge of quality standards such as ISO are essential for this role.

What are the key skills and qualifications needed to thrive as a Quality Management System (QMS) Specialist, and why are they important?

To thrive as a Quality Management System (QMS) Specialist, you need a solid understanding of quality standards (such as ISO 9001), process improvement methodologies, and experience with audits, often supported by a degree in engineering or a related field. Familiarity with QMS software platforms, document control systems, and relevant certifications like ISO 9001 Lead Auditor or Six Sigma is typically required. Strong attention to detail, analytical thinking, and effective communication are vital soft skills for ensuring compliance and driving quality initiatives. These skills and qualifications are important because they help organizations maintain regulatory compliance, improve efficiency, and deliver high-quality products or services.

Is QMS a good career?

A career in Quality Management Systems (QMS) involves developing and maintaining quality standards within organizations, often requiring knowledge of standards like ISO 9001. It can be a stable and rewarding field for those with attention to detail, problem-solving skills, and familiarity with auditing and compliance processes. Opportunities exist across various industries, including manufacturing, healthcare, and technology, with certifications enhancing job prospects.

What jobs pay 500,000 a year in the US?

High-paying jobs that can reach or exceed $500,000 annually include executive roles such as CEOs, CFOs, and other C-suite positions, as well as successful entrepreneurs, top-tier investment bankers, and certain specialized medical professionals like neurosurgeons. These roles typically require extensive experience, advanced skills, and often involve significant responsibilities or ownership stakes.

What are some common challenges faced by professionals working in Quality Management Systems (QMS) roles, and how can they be effectively managed?

Professionals in QMS roles often encounter challenges such as ensuring consistent compliance with changing industry regulations, promoting a culture of quality across diverse teams, and managing documentation efficiently. Effective communication and regular training are vital for keeping teams aligned with quality standards. Additionally, implementing robust digital tools for document control and ongoing audits can streamline processes and make regulatory compliance more manageable. Collaboration with cross-functional teams is key to identifying improvement opportunities and resolving quality issues promptly.

What qualifications do I need to be a QA manager?

A QA manager typically needs a bachelor's degree in quality assurance, engineering, or a related field, along with several years of experience in quality control or assurance roles. Certifications such as ASQ Certified Quality Manager (CQE) or Six Sigma are often preferred, and strong leadership, communication, and knowledge of quality management systems like ISO 9001 are essential.

What are QMS professionals and what do they do?

QMS professionals are experts who manage and implement Quality Management Systems within organizations. Their main role is to ensure that a company’s products or services consistently meet customer and regulatory requirements by developing, maintaining, and improving quality policies and procedures. They conduct audits, facilitate compliance with standards like ISO 9001, and drive continuous improvement initiatives. QMS professionals work across industries such as manufacturing, healthcare, and services to help organizations achieve high standards of quality and efficiency.
What are the most commonly searched types of Qms jobs in Indiana? The most popular types of Qms jobs in Indiana are:
What are popular job titles related to Qms jobs in Indiana? For Qms jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Qms jobs in Indiana look for? The top searched job categories for Qms jobs in Indiana are:
What cities in Indiana are hiring for Qms jobs? Cities in Indiana with the most Qms job openings:
Qms jobs near you
Infographic showing various Qms job openings in Indiana as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $114,103 per year, or $54.9 per hour.

Quality Associate II - QMS

EKF Diagnostics Inc

South Bend, IN • On-site

Full-time

Posted 9 days ago

Job description

Job Type
Full-time
Description
SUMMARY OF POSITION:
The Quality Associate II - Quality Management System (QMS) supports the development, maintenance, and continuous improvement of the QMS in alignment with ISO 13485, ISO 9001, FDA QMSR, and, as applicable, pharmaceutical cGMP requirements (21 CFR Parts 210/211 and ICH Q7), among other applicable requirements. This role focuses on CAPA, Internal Audits, Supporting External Audits, Training, Batch Release, and Supplier Qualification and Quality Agreements, QMS-level risk management. The position ensures the QMS remains compliant, effective, and inspection-ready.
ESSENTIAL FUNCTIONS, included but not limited to:
QMS Quality Oversight
  • Administer and maintain QMS processes including CAPA, internal audits and training SOPs.
  • Lead or support CAPA investigations, ensuring strong root-cause analysis, effectiveness checks, and timely closure.
  • Support internal audit planning, execution, reporting, and follow-up activities.
  • Support QA Manager and QMS Documentation Lead with document control and change management activities, including SOPs, forms, labels, IFUs, and controlled templates.
  • Maintain and oversee the training management system.
  • Support QA review of the feedback and complaint handling activities, escalate to Regulatory as needed.
  • Perform quality review of supplier approval process, including risk assessments.
  • Review and approve batch records and final product documentation.
  • Support risk management activities (ISO 14971), as needed.
  • Perform trend analysis across QMS processes (CAPA, complaints, audits, training, etc.) and escalate trends. Prepare reports for quality review board, management review, etc.
  • Support the training program by managing the training matrix, ensuring training assignments are accurate, current, and aligned with role requirements; monitor completion status and maintain compliant training records.

Batch Release
  • Review and approve batch records and final product documentation.
  • Ensure completeness, accuracy, and compliance of DHRs, COAs, and supporting documentation.

Documentation & Compliance
  • Ensure quality related documentation complies with ISO 13485, ISO 9001 and FDA 21 CFR 820 (QMSR), and other applicable requirements.
  • Draft, revise, and maintain SOPs, work instructions, forms, and controlled documents as required.
  • Support and participate in internal and external audits.
  • Ensure that batch reviews are conducted by personnel independent from the manufacturing, production or testing activities to ensure objective assessment and prevent conflicts of interest.

Documentation & Compliance
  • Ensure quality related documentation complies with ISO 13485, ISO 9001 and FDA 21 CFR 820 (QMSR)
  • Support operations in ensuring their documentation complies with requirements as applicable, ISO 13485, ISO 9001 and FDA 21 CFR 820 (QMSR), etc.
  • Draft, revise, and maintain SOPs, work instructions, forms, and controlled documents related to operations quality.
  • Support internal and external audits by providing quality records and participating in audit activities.

Training & Cross-Functional Support
  • Provide training on QMS, Continuous Improvements GMP, GDP, and compliance requirements, as applicable.
  • Cross-train with the Quality team and provide support during peak workload periods.
  • Collaborate with Manufacturing, Procurement, Technical Support, Compliance (QC, RA) and other departments as applicable to ensure compliant operations.

OTHER FUNCTIONS:
  • Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area.
  • Assist as needed in other areas of the Company where training requirements have been completed.
  • Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:
  • Perform other duties as assigned.

TRAVEL:
  • 5% annually for supplier audits or cross-site activities.

Requirements
REQUIRED QUALIFICATIONS:
  • Bachelor's degree (B.A. /B.S.) from an accredited college or university in a science related field.
  • Legally authorized to work in the United States.
  • Three (3) years of quality experience in relation to medical devices or In vitro diagnostics devices.
  • Strong knowledge of various standards and regulations such as ISO 9001, ISO 13485, ISO 14971, Quality Management System Regulation (QMSR) (21 CFR Part 820).

PREFERRED QUALIFICATIONS:
  • Five (5) years proven quality experience in relation to In vitro diagnostics devices.
  • Knowledgeable supplier programs, CAPA, Internal Audits, Risk Management
  • Working knowledge of pharmaceutical cGMP requirements (21 CFR Parts 210/211 and ICH Q7); beneficial as the organization transitions from a CMO to a CDMO.

BASIC SKILLS AND ABILITIES:
  • Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
  • Good computer skills including Microsoft Word, Excel, Outlook.
  • Detail oriented with a high level of accuracy, efficiency, and accountability.
  • Excellent organizational skills to meet goals and set priorities.
  • Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Initiative to offer new innovative ideas and improve processes.
  • Ability to work independently and as a member of various teams and committees.

REASONING ABILITIES:
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Must have strong analytical and planning skills sufficient to determine resources and time required to complete projects

LANGUAGE SKILLS:
  • Good written and oral communication skills; with the ability to interface well with management, internal employees, FDA, notified bodies, and other international regulatory authorities.
  • Ability to read, analyze, and interpret general business periodicals, professional scientific and technical journals, technical procedures, financial reports, legal documents, and governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

MATHEMATICAL SKILLS:
  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

VISUAL ACUITY:
  • Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.

PHYSICAL DEMANDS:
  • Must be able to wear and work in personnel protective equipment (PPE) as required.
  • Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
  • Stationary position sitting for prolonged periods of time while utilizing standard office tools.
  • Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; dexterity and coordination necessary to handle files and single pieces of paper.
  • The ability to hear, understand, and distinguish speech.
  • Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations.
  • Frequently lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds, and rarely lift and/or move up to 50 pounds.
  • Often move about inside the facility to access office machinery, correspond with other departments, attend meetings/training, etc.
  • Occasionally reaching for items above and below desk level.
  • Occasionally required to climb or balance; squat, stoop, kneel, crouch, or crawl, and smell.

ENVIRONMENT CONDITIONS:
  • Well lit, heated/air-conditioned indoor office setting with adequate ventilation.
  • The noise level in the work environment is low.
  • Periodic exposure to low temperatures in controlled refrigerators and/or freezers.
  • Some exposure to hazards or physical risks which require following basic safety precaution

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