Quality Associate II - QMS

Quality Associate II – Quality Management System (QMS)

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.

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.

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…