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Quality Associate Ii Jobs (NOW HIRING)

EKF DIAGNOSTICS INC

Quality Associate II - QMS

Boerne, TX · On-site

$28 - $37/hr

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, MDSAP and ...

EKF DIAGNOSTICS INC

Quality Associate II - QMS

Boerne, TX · On-site

$28 - $37/hr

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, MDSAP and ...

Codis

Quality Associate

Seymour, IN

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Quality Associate Pay rate based on experience! About Codis At Codis (formerly Particle Dynamics ... 2% - with immediate vesting * Clean, climate-controlled pharmaceutical environment * Growth ...

Yokowo Manufacturing of America, Llc.

Be Seen First

Quality Associate

Hilliard, OH · On-site

$15/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Quality associate Quality Assurance Associate We are looking for an individual who can meet the following criteria: 1. Have good attendance 2. Stand the entire shift 3. Good communication skills 4. ...

Codis

Quality Associate

Seymour, IN · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Quality Associate Pay rate based on experience! About Codis At Codis (formerly Particle Dynamics ... 2% - with immediate vesting * Clean, climate-controlled pharmaceutical environment * Growth ...

ENTEK INTERNATIONAL LLC

Quality Associate

Lebanon, OR

$22.10/hr

What You'll Do As a Quality Associate , you'll play a key role in supporting ENTEK's quality ... One (1) to two (2) years of quality control experience in a manufacturing environment * Experience ...

ENTEK

Quality Associate

Lebanon, OR · On-site

$22.10/hr

What You'll Do As a Quality Associate , you'll play a key role in supporting ENTEK's quality ... One (1) to two (2) years of quality control experience in a manufacturing environment * Experience ...

Mettler Toledo

Quality Associate

Oakland, CA · On-site

$19 - $22/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

A Level II Associate is always watchful for quality risks around them and takes action even when outside their normal inspection duties. The individual MAY be cross trained to work in multiple ...

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Quality Associate Ii information

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How much do quality associate ii jobs pay per hour?

As of Aug 16, 2026, the average hourly pay for quality associate ii in the United States is $26.93, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $31.49 per hour, depending on experience, location, and employer.

What is the difference between Quality Associate Ii vs Quality Control Technician?

AspectQuality Associate IIQuality Control Technician
Required CredentialsTypically an associate degree or higher in a related fieldOften an associate degree or technical certification
Work EnvironmentOffice and manufacturing settings, supporting quality processesLaboratory and production environments, performing testing and inspections
Employer & Industry UsageCommon in manufacturing, pharmaceuticals, and biotechPrimarily in manufacturing and production sectors
Search & Comparison IntentUnderstanding roles, responsibilities, and career pathFocus on testing procedures and technical skills

The main difference between a Quality Associate II and a Quality Control Technician lies in their focus and responsibilities. Quality Associate II roles often involve supporting quality systems, documentation, and process improvements, while Quality Control Technicians primarily perform testing and inspections to ensure product quality. Both roles require similar educational backgrounds but differ in daily tasks and work environments.

What are some typical challenges a quality associate ii might face when working on cross-departmental projects?

As a Quality Associate II, you may frequently collaborate with teams from production, engineering, and regulatory affairs. One common challenge is ensuring clear communication and alignment on quality standards across departments, especially when project timelines are tight or priorities differ. You’ll often need to balance attention to detail with efficiency, managing documentation and compliance tasks while supporting process improvements. Developing strong working relationships and proactive communication skills can help you address these challenges effectively and contribute to smoother project execution.

What is a quality associate ii?

Quality Associate IIs are professionals who work in quality assurance or quality control, typically within manufacturing, pharmaceuticals, or other regulated industries. They are responsible for ensuring products and processes meet established standards and regulatory requirements. Their duties may include inspecting materials, reviewing documentation, conducting audits, and collaborating with other departments to resolve quality issues. Quality Associate IIs often have more experience than entry-level associates and may assist in training or supervising junior staff. Their work helps maintain product safety, consistency, and compliance.

What are the key skills and qualifications needed to thrive as a quality associate ii?

To thrive as a Quality Associate II, you need a solid understanding of quality assurance processes, regulatory compliance, and technical documentation, often supported by a bachelor's degree in a scientific or technical field. Familiarity with quality management systems (QMS), statistical analysis tools, and industry-specific standards such as ISO or GMP is typically required. Strong attention to detail, analytical thinking, and effective communication skills set outstanding candidates apart. These abilities are crucial to ensuring product quality, regulatory adherence, and continuous process improvement in a highly regulated environment.
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Infographic showing various Quality Associate Ii job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $56,018 per year, or $26.9 per hour.

Quality Associate II - QMS

EKF Diagnostics Inc

South Bend, IN • On-site

Full-time

Re-posted 18 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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