QE Engineer II - QMS Compliance

We need to output HTML fragment with sections: About the role, Responsibilities (What You Will Do), Requirements (Minimum Qualifications), Preferred Qualifications maybe as part of Requirements? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We should include sections only if posting has real specific content. The posting includes: About the Role, What You Will Do (Responsibilities), Minimum Qualifications, Preferred Qualifications, Knowledge, Skills & Abilities (Skills). Also there is a "Join Us" paragraph but that's more marketing; we could include maybe as part of About the role? But we can ignore if not needed. No Pay, Schedule, Benefits mentioned. So we should not create those sections. We need to preserve all substantive information, not invent or summarize away detail. Use

• for any list of duties/requirements/benefits, and

  for prose. We need to parse the content. First, we have an introductory paragraph before About the Role: "Make an Impact Joining Oxoid Remel Microbiology, you’ll play an active part in helping deliver meaningful impact. We play a crucial role in supporting accurate disease identification and targeted treatment, food and beverage safety, and pharmaceutical manufacturing integrity. Our products and services are designed to meet high standards of quality and performance, helping our customers achieve their objectives efficiently and effectively. As a Quality Engineer II – QMS Compliance, you’ll help strengthen our Quality Management System and support a culture of quality, compliance, accountability, and continuous improvement. You’ll partner across the organization to investigate quality events, identify true root causes, develop effective corrective actions, assess risk, and ensure changes are implemented in a controlled and compliant manner." That's prose; we could put it in a

  before sections. The instruction: Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

  or drop it. So we can keep that intro as a

  . Then we have sections: - About the Role: includes paragraphs about role description. - What You Will Do: includes bullet-like list but actually paragraphs with headings: Investigations & Root Cause Analysis, CAPA Management, Management of Change & Change Control, QMS Compliance & Continuous Improvement, Audit & Inspection Readiness. Each of these subheadings with bullet-like sentences. We need to output as

  • for any list of duties/requirements/benefits. So we can treat each bullet as a list item. The subheadings could be maybe or just part of li text. We'll keep them inside li. - Minimum Qualifications: list of bullet points (each line). We'll output as
    • . - Preferred Qualifications: list of bullet points. - Knowledge, Skills & Abilities: list of bullet points. We should not include sections like Benefits, Pay, Schedule. We need to output ONLY the HTML fragment, no /, no markdown fences. Thus final HTML:

      Intro paragraph...

      About the Role

      ... (the paragraph(s) under About the Role)

      Responsibilities

      • Investigations & Root Cause Analysis Provide Quality oversight and technical support for deviations, nonconformances, investigations, and other quality events. Facilitate and/or support structured Root Cause Analysis using appropriate problem-solving tools and methodologies. Partner with investigation owners and cross-functional teams to ensure investigations are thorough, scientifically sound, risk-based, and completed within established timelines. Help teams distinguish symptoms from true root causes and appropriately challenge conclusions when supporting evidence is insufficient. Provide coaching and guidance to cross-functional personnel on investigation practices and root cause analysis methodologies.
      • CAPA Management Support the development, implementation, and closure of effective Corrective and Preventive Actions (CAPAs). Evaluate CAPA plans to ensure actions appropriately address identified root causes and reduce the likelihood of recurrence. Support CAPA effectiveness verification activities, including establishing meaningful effectiveness criteria and reviewing supporting data. Monitor CAPA records for aging, overdue actions, recurring issues, and potential compliance risks.
      • Management of Change & Change Control Provide Quality support for Management of Change (MOC) and change-control activities. Assess proposed changes for potential impact to product quality, validated processes, procedures, equipment, facilities, materials, training, and regulatory requirements. Ensure appropriate risk assessments, implementation activities, approvals, documentation, and post-implementation requirements are completed. Partner cross-functionally to ensure changes are appropriately evaluated and implemented without compromising product quality or compliance.
      • QMS Compliance & Continuous Improvement Monitor QMS records for aging, overdue actions, recurring issues, and compliance risks. Support trending and analysis of investigation, CAPA, MOC, and other QMS performance metrics to identify systemic issues and improvement opportunities. Review and approve Quality System records in accordance with established procedures and applicable requirements. Identify opportunities to improve QMS processes, reduce record cycle time, improve right-first-time documentation, and strengthen overall compliance. Participate in cross-functional quality improvement projects and site quality initiatives. Support the development and revision of procedures, work instructions, forms, and other controlled Quality System documentation. Promote a culture of quality, accountability, compliance, and continuous improvement. Perform additional Quality System responsibilities as assigned.
      • Audit & Inspection Readiness Support internal, customer, corporate, and regulatory audit-readiness activities. Assist with responses and remediation activities associated with audit observations and Quality System findings. Help ensure Quality System records and supporting documentation remain accurate, complete, timely, and inspection-ready.

      Requirements

      • Bachelor’s degree in Engineering, Science, Quality, or a related technical discipline.
      • Typically 3+ years of experience in Quality Assurance, Quality Engineering, manufacturing quality, or Quality Systems within a regulated environment.
      • Experience supporting or managing investigations, deviations, nonconformances, CAPAs, change controls, or other QMS processes.
      • Working knowledge of Root Cause Analysis and structured problem-solving methodologies.
      • Strong technical writing and documentation skills.
      • Demonstrated ability to evaluate data, identify trends, assess risk, and develop practical solutions.
      • Ability to work effectively with cross-functional teams and influence without direct authority.
      • Strong organizational skills with the ability to manage multiple priorities and timelines.
      We could also have a separate "Preferred Qualifications" section as

      Preferred Qualifications

      with ul. And "Knowledge, Skills & Abilities" as

      Skills

      maybe. The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we could map: - About the Role -> About the role - Responsibilities -> Responsibilities - Minimum Qualifications -> Requirements - Preferred Qualifications -> Qualifications (maybe) - Knowledge, Skills & Abilities -> Skills Thus we will output sections accordingly. We need to preserve all substantive information; do not invent or summarize away detail. So we must include all bullet points exactly as given. Let's extract the exact text. From posting: Minimum Qualifications bullet list: - Bachelor’s degree in Engineering, Science, Quality, or a related technical discipline. - Typically 3+ years of experience in Quality Assurance, Quality Engineering, manufacturing quality, or Quality Systems within a regulated environment. - Experience supporting or managing investigations, deviations, nonconformances, CAPAs, change controls, or other QMS processes. - Working knowledge of Root Cause Analysis and structured problem-solving methodologies. - Strong technical writing and documentation skills. - Demonstrated ability to evaluate data, identify trends, assess risk, and develop practical solutions. - Ability to work effectively with cross-functional teams and influence without direct authority. - Strong organizational skills with the ability to manage multiple priorities and timelines. Preferred Qualifications bullet list: - Experience within pharmaceutical, biotechnology, medical device, diagnostics, life sciences, or another highly regulated manufacturing environment. - Experience working within an electronic Quality Management System (eQMS). - Experience with investigation and Root Cause Analysis tools such as 5 Why, Fishbone/Ishikawa, Fault Tree Analysis, Kepner-Tregoe, or similar methodologies. - Experience with CAPA effectiveness verification and Quality System trending. - Familiarity with risk-management tools such as FMEA. - Experience supporting internal or external audits. - Working knowledge of applicable GMP, FDA, ISO, and other regulatory or Quality System requirements. - Lean, Six Sigma, Practical Process Improvement (PPI), or other continuous improvement experience is beneficial. Knowledge, Skills & Abilities bullet list: - Strong understanding of Quality Management System principles. - Strong investigation, analytical, and critical-thinking skills. - Ability to distinguish symptoms from true root causes and challenge conclusions when supporting evidence is insufficient. - Ability to translate complex quality issues into clear actions and expectations. - Strong attention to detail while maintaining focus on overall compliance and business risk. - Ability to appropriately prioritize quality events based on product, process, compliance, and patient/customer risk. - Effective verbal and written communication skills. - Strong interpersonal skills with the ability to collaborate across multiple functions and organizational levels. - Comfortable coaching others and providing constructive Quality guidance. - Demonstrated ownership, accountability, and follow-through. Now About the Role paragraph(s): From posting: "The Quality Engineer II – QMS Compliance provides quality systems and compliance support to ensure the effective execution and continuous improvement of the site Quality Management System (QMS). This role partners cross-functionally with Operations, Quality Control, Engineering, Manufacturing Sciences, and other functional teams to support the timely and compliant execution of investigations, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and Management of Change (MOC). The Quality Engineer II will serve as a subject matter resource for investigation and quality system processes, helping teams identify true root causes, develop effective corrective and preventive actions, assess risk, and ensure changes are appropriately evaluated and implemented. The position will also support QMS metrics, compliance monitoring, audit readiness, and continuous improvement initiatives." That's the About the Role content. Now Responsibilities (What You Will Do) we have subheadings with paragraphs. We'll convert each subheading's paragraph into a list item. We need to ensure we keep all details. Let's extract each subheading's text exactly. Investigations & Root Cause Analysis: "Provide Quality oversight and technical support for deviations, nonconformances, investigations, and other quality events.Facilitate and/or support structured Root Cause Analysis using appropriate problem-solving tools and methodologies.Partner with investigation owners and cross-functional teams to ensure investigations are thorough, scientifically sound, risk-based, and completed within established timelines.Help teams distinguish symptoms from true root causes and appropriately challenge conclusions when supporting evidence is insufficient.Provide coaching and guidance to cross-functional personnel on investigation practices and root cause analysis methodologies." Note there are no spaces after periods; but we can keep as is or add spaces for readability. The instruction: preserve ALL substantive information; do not invent or summarize away detail. Adding spaces is not changing substantive info; it's just formatting. Probably fine. CAPA Management: "Support the development, implementation, and closure of effective Corrective and Preventive Actions (CAPAs).Evaluate CAPA plans to ensure actions appropriately address identified root causes and reduce the likelihood of recurrence.Support CAPA effectiveness verification activities, including establishing meaningful effectiveness criteria and reviewing supporting data.Monitor CAPA records for aging, overdue actions, recurring issues, and potential compliance risks." Management of Change & Change Control: "Provide Quality support for Management of Change (MOC) and change-control activities.Assess proposed changes for potential impact to product quality, validated processes, procedures, equipment, facilities, materials, training, and regulatory requirements.Ensure appropriate risk assessments, implementation activities, approvals, documentation, and post-implementation requirements are completed.Partner cross-functionally to ensure changes are appropriately evaluated and implemented without compromising product quality or compliance."