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Qms Manager Jobs in Indiana (NOW HIRING)

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Quality Engineer

Indianapolis, IN · On-site

$75K - $85K/yr

Manage controlled changes within the QMS in collaboration with the Quality Manager and relevant departments. The ideal candidate: Strong understanding of quality management systems (e.g., ISO 9001 ...

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Qms Manager information

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$22.8K

$82K

$150.3K

How much do qms manager jobs pay per year?

As of Aug 8, 2026, the average yearly pay for qms manager in Indiana is $81,986.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,900.00 and $129,400.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a QMS manager, and why are they important?

To thrive as a QMS Manager, you need expertise in quality management systems, regulatory compliance, and process improvement, typically supported by a relevant degree and experience in quality assurance. Familiarity with ISO standards (such as ISO 9001), audit management tools, and quality software platforms is essential. Strong leadership, problem-solving skills, and effective communication help drive a culture of continuous improvement and team alignment. These competencies ensure that organizational processes meet regulatory requirements and consistently deliver high-quality outcomes.

How does a QMS manager typically collaborate with other departments to ensure compliance and continuous improvement?

A QMS Manager regularly works cross-functionally with departments such as production, engineering, and procurement to implement and maintain quality standards. This involves coordinating audits, facilitating training sessions, and gathering feedback to identify areas for process improvement. Effective communication and negotiation skills are essential, as the QMS Manager must align diverse teams toward compliance goals and foster a culture of continuous improvement. Regular meetings and collaborative problem-solving are part of ensuring that quality objectives are met across the organization.

What is a QMS manager?

QMS Managers, or Quality Management System Managers, are professionals responsible for developing, implementing, and overseeing an organization's quality management system. They ensure that processes and products meet established quality standards and comply with relevant regulations. Their duties often include conducting audits, managing documentation, training staff on quality procedures, and driving continuous improvement initiatives. QMS Managers play a crucial role in maintaining customer satisfaction and supporting organizational efficiency.

What is the difference between Qms Manager vs Quality Assurance Supervisor?

AspectQms ManagerQuality Assurance Supervisor
CertificationsISO 9001 Lead Auditor, CQEISO 9001 Lead Auditor, CQE
Work EnvironmentOversees quality management systems across departmentsSupervises quality assurance team and daily testing activities
Industry UsageUsed in manufacturing, aerospace, automotiveCommon in manufacturing, pharmaceuticals, food industry
Primary FocusDeveloping, maintaining, and improving QMSMonitoring product quality and compliance

The Qms Manager and Quality Assurance Supervisor roles share similar certifications and industry usage, but the Qms Manager focuses on managing the entire quality management system, while the Supervisor concentrates on daily quality assurance activities. Both positions are vital for ensuring product quality and compliance within manufacturing and related industries.

What are popular job titles related to Qms Manager jobs in Indiana? For Qms Manager jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Qms Manager jobs in Indiana look for? The top searched job categories for Qms Manager jobs in Indiana are:
What cities in Indiana are hiring for Qms Manager jobs? Cities in Indiana with the most Qms Manager job openings:
Qms Manager jobs near you
Infographic showing various Qms Manager job openings in Indiana as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution, with an average salary of $81,986 per year, or $39.4 per hour.

Quality Associate II - QMS

EKF Diagnostics Inc

South Bend, IN • On-site

Full-time

Re-posted 10 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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