Quality Associate II - QMS

EKF Diagnostics•Sound Bend, IN

2d•Onsite

About The 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.

Requirements

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

Nice To Haves

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.

Responsibilities

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