Engineer II, Quality

We need to output HTML fragment with sections: use

for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We need to parse the job description. Content: Position Summary JOB DESCRIPTION The Manufacturing Quality Engineer II is an independent Quality Engineer responsible for routine manufacturing quality assurance support for an assigned product line, process family, workcell, or manufacturing area. The role owns routine NCMRs, complaint manufacturing reviews, CAPA support, quality-health metrics, and proactive defect-prevention activities. Essential Duties & Responsibilities: list of duties. Knowledge, Skills & Qualifications: list. Education And Experience: list. Physical Requirements And Work Environment: list. About Us: description. ICU Medical EEO Statement etc: boilerplate to remove. We need to map to sections. We have "About the role": could be Position Summary. "Responsibilities": Essential Duties & Responsibilities. "Requirements": maybe Education And Experience? Or Knowledge, Skills & Qualifications? The spec says we can have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which to include based on content. We have content for: - About the role: Position Summary. - Responsibilities: Essential Duties & Responsibilities. - Requirements: maybe Education And Experience (must be at least 18, degree, years experience). Could also include Physical Requirements? But Physical Requirements is separate maybe not a standard heading; we could include under Requirements? But spec says only use those headings; we can include Requirements for education/experience, and maybe Skills for knowledge/skills. - Qualifications: maybe Knowledge, Skills & Qualifications? Actually that heading includes knowledge, skills & qualifications. Could split: Qualifications for certifications (Yellow Belt, Green Belt, ASQ CQE). Skills for competencies (Pareto, 5-Why, etc). But we have overlapping. Better: Use sections: - About the role (Position Summary) - Responsibilities (Essential Duties & Responsibilities) - Requirements (Education And Experience) - Qualifications (Knowledge, Skills & Qualifications) maybe includes knowledge, skills, qualifications. - Skills (maybe we can separate but risk duplication). Could combine knowledge/skills into Qualifications and not have separate Skills. But spec says we can include Skills section if posting has real specific content for it. We have specific skills: competency in Pareto analysis, stratification, trend charts, basic SPC/capability, 5-Why, fishbone, A3/PDCA, Kaizen co-leadership, DMAIC basics; strong communication, cross-functional coordination, stakeholder follow-up, ability to balance documentation execution with proactive defect prevention. That's skills. We also have knowledge: independent knowledge of NCMR ownership, routine investigation leadership, complaint manufacturing review, CAPA support, technical writing, containment, risk-based disposition, QMS record quality. Working knowledge of manufacturing-floor support, basic validation/process-control support, PFMEA/control plan linkage, audit-ready record expectations. Thus we could have: - Qualifications: Education And Experience (maybe also certifications). But we have Education And Experience separate. Better to follow typical job posting: About the role, Responsibilities, Requirements (education/experience), Qualifications (knowledge/skills), Skills (maybe technical skills), Benefits, Pay, Schedule. We have no Benefits, Pay, Schedule info. So omit those. We have Physical Requirements And Work Environment: could be part of Requirements? Not exactly. Could be a separate section but not in allowed headings. Could fold into Requirements as a short paragraph? The spec says we can fold minor metadata into a short

or drop it. Physical Requirements is not minor metadata? It's substantive but not a standard heading; we could include under Requirements as a paragraph. About Us: could be part of About the role? Might be separate but not a standard heading. Could fold into About the role as additional paragraph. We must preserve all substantive information; not invent or summarize away detail. So we need to include all details from the posting, but we can reorganize under allowed headings. Thus we need to output HTML with sections:

About the role

Position Summary ... plus About Us paragraph maybe.

Responsibilities

• ... each duty

Requirements

Education And Experience details + Physical Requirements And Work Environment maybe.

Qualifications

Knowledge, Skills & Qualifications details (knowledge and working knowledge).

Skills

• ... specific skills list

We must not repeat job title as heading. Not include Job ID etc. Remove boilerplate EEO etc. Let's extract details precisely. Position Summary paragraph: "The Manufacturing Quality Engineer II is an independent Quality Engineer responsible for routine manufacturing quality assurance support for an assigned product line, process family, workcell, or manufacturing area. The role owns routine NCMRs, complaint manufacturing reviews, CAPA support, quality-health metrics, and proactive defect-prevention activities." About Us paragraph: "ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.Significant US IV solutions manufacturing and supply capabilities." We need to keep that as is, maybe combine with About the role. Responsibilities list (Essential Duties & Responsibilities): - Own routine NCMR investigations from initial evaluation through closure, including containment, affected-product impact assessment, recurrence review, technical rationale, disposition recommendation, and closure logic. - Ensure NCMR records include clear problem statements, objective evidence, investigation summary, product impact assessment, disposition rationale, execution evidence, and timely record updates. - Support CAPA initiation assessments and provide evidence-based recommendations when recurrence, severity, trends, or systemic weaknesses warrant escalation. - Lead or support routine root cause analysis using 5-Why, fishbone, Pareto, stratification, trend charts, and related structured problem-solving tools. - Own manufacturing review portions of internal and external complaints, including production history, NCMR/CAPA history, inspection/test data, potential escapes, and product risk. - Provide independent production quality support for line investigations, rework/sort controls, inspection method clarification, process change review, and manufacturing quality risk assessment. - Support process validation, equipment/fixture qualification, manufacturing transfers, acceptance criteria updates, control plans, and PFMEA maintenance as applicable. - Present monthly area quality-health summaries covering top defects, aging NCMRs, complaint linkages, CAPA signals, and improvement actions. - Lead small-to-medium defect-reduction, documentation, workflow, inspection, process-control, or Kaizen improvement projects and maintain action logs, charters, sustainment plans, and effectiveness checks. - Coach QE I or Quality Specialist personnel on record completeness, CI action tracking, and task follow-up. We need to keep each as

. Knowledge, Skills & Qualifications section: "Independent knowledge of NCMR ownership, routine investigation leadership, complaint manufacturing review, CAPA support, technical writing, containment, risk-based disposition, and QMS record quality. Working knowledge of manufacturing-floor support, basic validation/process-control support, PFMEA/control plan linkage, and audit-ready record expectations. Competency in Pareto analysis, stratification, trend charts, basic SPC/capability, 5-Why, fishbone, A3/PDCA, Kaizen co-leadership, and DMAIC basics. Strong communication, cross-functional coordination, stakeholder follow-up, and ability to balance documentation execution with proactive defect prevention." We could split knowledge and skills: but we have separate Skills section for the competency list maybe. But the above includes both knowledge and skills. To avoid duplication, we could put knowledge (independent knowledge, working knowledge) under Qualifications, and the competency and communication under Skills. Thus: Qualifications: independent knowledge of NCMR ownership, routine investigation leadership, complaint manufacturing review, CAPA support, technical writing, containment, risk-based disposition, and QMS record quality. Working knowledge of manufacturing-floor support, basic validation/process-control support, PFMEA/control plan linkage, and audit-ready record expectations. Skills: Competency in Pareto analysis, stratification, trend charts, basic SPC/capability, 5-Why, fishbone, A3/PDCA, Kaizen co-leadership, and DMAIC basics. Strong communication, cross-functional coordination, stakeholder follow-up, and ability to balance documentation execution with proactive defect prevention. Education And Experience: "Must be at least 18 years of age. Bachelor’s degree from an accredited college or university in Engineering, Science, Quality, Technology, or a related discipline; or equivalent combination of education and relevant experience. Typically 2-5 years of quality engineering, manufacturing engineering, supplier quality, process engineering, or regulated manufacturing experience. Experience with NCMRs, CAPA support, complaint investigation, process control, root cause analysis, and manufacturing-floor support preferred. Yellow Belt expected or strongly preferred; Green Belt training/candidate status recommended. ASQ CQE or equivalent quality training is a plus." Physical Requirements And Work Environment: "This role requires both manufacturing and office environment. While working in the manufacturing environment, high-noise areas, radiological hazards, lasers, and/or biological hazards may be encountered. Lift up to 40 lbs unassisted. Typically requires travel less than 5% of the time." We need to include that somewhere; maybe under Requirements as a paragraph after education/experience. Thus Requirements section will contain education/experience plus physical requirements. We must not create Benefits, Pay, Schedule sections. Now produce HTML fragment. We need to ensure we use

for each section heading,

• for lists,

  for prose. We must not include any extra text outside HTML. Let's craft. First section About the role:

  About the role

  The Manufacturing Quality Engineer II is an independent Quality Engineer responsible for routine manufacturing quality assurance support for an assigned product line, process family, workcell, or manufacturing area. The role owns routine NCMRs, complaint manufacturing reviews, CAPA support, quality-health metrics, and proactive defect-prevention activities.

  ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.Significant US IV solutions manufacturing and supply capabilities.

  Second Responsibilities:

  Responsibilities

  • Own routine NCMR investigations from initial evaluation through closure, including containment, affected-product impact assessment, recurrence review, technical rationale, disposition recommendation, and closure logic.
  • Ensure NCMR records include clear problem statements, objective