Manager, Quality Engineering

We need to output HTML fragment with sections only if content present. Use

for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to extract content. Job posting includes: Summary Description (maybe About the role). Then Essential Duties And Responsibilities (Responsibilities). Then Desired Minimum Qualifications (Qualifications). Also Education, Experience, etc. Tools and equipment used (Skills). Salary Pay Range (Pay). Benefits: Additional Description for Pay Transparency lists benefits (medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insurance, savings plan (401(k))). Also mention bonus, commission, equity etc. So Benefits section. Schedule not mentioned, so omit. We must not repeat job title as heading. No Job ID. Remove boilerplate: EEO, legal, unsolicited agency submission, etc. Also remove "Changing lives..." intro? That's fluff but maybe part of About the role? It's generic marketing; but we need preserve substantive information. The intro is not substantive? It's generic but could be considered About the role? Might be okay to include as part of About the role paragraph. However instructions: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The intro is not boilerplate; it's marketing but maybe keep as part of About the role. We need to preserve all substantive info; not invent or summarize away detail. So we need to include details from responsibilities, qualifications, etc. Let's craft sections:

About the role

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Manager, Quality Engineering leads Quality Engineering support for manufacturing, product development, process improvement, validation, risk management, and technical issue resolution. The role ensures that products and processes are developed, validated, transferred, maintained, and improved in compliance with company procedures and applicable regulatory requirements. The Manager provides Quality Engineering partnership and technical expertise for nonconformances, CAPAs, customer complaints, and other cross-functional quality activities.

But we might be duplicating content; but okay. Better: Use the summary description: "Summary Description The Manager, Quality Engineering leads Quality Engineering support for manufacturing, product development, process improvement, validation, risk management, and technical issue resolution. The role ensures that products and processes are developed, validated, transferred, maintained, and improved in compliance with company procedures and applicable regulatory requirements. The Manager provides Quality Engineering partnership and technical expertise for nonconformances, CAPAs, customer complaints, and other cross-functional quality activities." Add the intro as separate paragraph? Might be okay. Responsibilities: list essential duties. Use

• each bullet. We need to capture all duties from "Essential Duties And Responsibilities". That's a long list. We'll need to include each bullet as
• . Let's extract: - Maintain a thorough understanding of applicable requirements and standards, including FDA GMPs, ISO 9001, ISO 14971, ISO 13485, MDSAP company policies and procedures, validation guidance, and other applicable standards. - Lead Quality Engineering support for Manufacturing, QA/QC, Regulatory Compliance, Product Development, and other business partners. - Build and develop a strong team of quality engineers through effective hiring, onboarding, coaching, goal setting, retention, and resource planning. - Participate in the development and implementation of new processes, process and product transfers, continuous improvement activities, and technical issue resolution. - Provide guidance on verification and validation plans, process validation and revalidation, test methods, sampling methods and plans, test equipment acquisition, sterilization validation and revalidation, and Process Excellence initiatives. - Lead or support technical investigations involving product, process, equipment, test method, validation, and manufacturing performance issues. - Provide Quality Engineering partnership and technical expertise for nonconformances, CAPAs, and customer complaint investigations, including technical assessment, investigation support, risk evaluation, root-cause analysis, action development, and effectiveness evaluations, as applicable. - Ensure Quality Engineering deliverables and assigned technical investigation activities are complete, accurate, scientifically sound, appropriately documented, and completed within established timelines. - Lead and document product and process risk-management activities within the Quality Engineering scope, including risk assessments supporting investigations, process changes, validation, transfers, and issue resolution. - Analyze engineering and manufacturing data, including process capability, statistical process control, validation results, recurring technical issues, and other relevant quality indicators, to identify opportunities for improvement and risk reduction. - Participate in the compilation and review of technical documentation supporting domestic and international regulatory submissions, inspections, and audits. - Participate in external and internal audits, including FDA, Notified Body, customer, and corporate audits, by providing Quality Engineering subject-matter expertise and objective evidence. - Benchmark regulatory and industry practices and participate in professional forums or committees that influence engineering, validation, risk-management, and quality practices. - Perform other related duties as necessary. That's all. Qualifications: Desired Minimum Qualifications includes Education, Experience, etc. We'll put as
  • items. Education: BS degree in Engineering or Science; ASQ/CQE certification strongly preferred. Experience: 7-10 years of quality assurance engineering, manufacturing engineering, validation, reliability, or related experience supporting manufacturing; product-development experience is a plus. Excellent written and verbal communication skills. Working knowledge of GMP, Quality Engineering, validation, risk management, and applicable Quality System requirements; medical-device industry experience strongly preferred. Demonstrated knowledge of FDA GMPs, ISO 9001, ISO 14971, ISO 13485, company policies and procedures, validation guidance, and other applicable standards. Demonstrated ability to think strategically, lead technical teams, manage priorities, and collaborate across functions. Tools and equipment used: Ability to use a computer, telephone, and general office equipment. Strong computer skills and familiarity with Microsoft Office applications are required. We could put that under Skills section. Pay: Salary Pay Range: $109,250.00 - $149,500.00 USD. Also mention bonus, commission, equity or other variable compensation. We'll include that. Benefits: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insurance, and savings plan (401(k)). Also mention bonus etc but that's compensation. We'll create Benefits
    • items. Now ensure we don't include headings with empty content. All sections have content. We must not include markdown fences. Just raw HTML. Let's construct. Potential duplication: The About the role paragraph may repeat some of responsibilities; but it's okay. We'll output:

      About the role

      Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Manager, Quality Engineering leads Quality Engineering support for manufacturing, product development, process improvement, validation, risk management, and technical issue resolution. The role ensures that products and processes are developed, validated, transferred, maintained, and improved in compliance with company procedures and applicable regulatory requirements. The Manager provides Quality Engineering partnership and technical expertise for nonconformances, CAPAs, customer complaints, and other cross-functional quality activities.

      Responsibilities

      • Maintain a thorough understanding of applicable requirements and standards, including FDA GMPs, ISO 9001, ISO 14971, ISO 13485, MDSAP company policies and procedures, validation guidance, and other applicable standards.
      • Lead Quality Engineering support for Manufacturing, QA/QC, Regulatory Compliance, Product Development, and other business partners.
      • Build and develop a strong team of quality engineers through effective hiring, onboarding, coaching, goal setting, retention, and resource planning.
      • Participate in the development and implementation of new processes, process and product transfers, continuous improvement activities, and technical issue resolution.
      • Provide guidance on verification and validation plans, process validation and revalidation, test methods, sampling methods and plans, test equipment acquisition, sterilization validation and revalidation, and Process Excellence initiatives.
      • Lead or support technical investigations involving product, process, equipment, test method, validation, and manufacturing performance issues.
      • Provide Quality Engineering partnership and technical expertise for nonconformances, CAPAs, and customer complaint investigations, including technical assessment, investigation support, risk evaluation, root-cause analysis, action development, and effectiveness evaluations, as applicable.
      • Ensure Quality Engineering deliverables and assigned technical investigation activities are complete, accurate, scientifically sound, appropriately documented, and completed within established timelines.
      • Lead and document product and process risk-management activities within the Quality Engineering scope, including risk assessments supporting investigations, process changes, validation, transfers, and issue resolution.
      • Analyze engineering and manufacturing data, including process capability, statistical process control, validation results, recurring technical issues, and other relevant quality indicators, to identify opportunities for improvement and risk reduction.
      • Participate in the compilation and review of technical documentation supporting domestic and international regulatory submissions, inspections, and audits.
      • Participate in external and internal audits, including FDA, Notified Body, customer, and corporate audits, by providing Quality Engineering subject-matter expertise and objective evidence.
      • Benchmark regulatory and industry practices and participate in professional forums or committees that influence engineering, validation, risk-management, and quality practices.
      • Perform other related duties as necessary.

      Qualifications

      • BS degree in Engineering or Science; ASQ/CQE certification strongly preferred.
      • 7-10 years of quality assurance engineering, manufacturing engineering, validation, reliability, or related experience supporting manufacturing; product-development experience is a plus.
      • Excellent written and verbal communication skills.
      • Working knowledge of GMP, Quality Engineering, validation, risk management, and applicable Quality System requirements; medical-device industry experience strongly preferred.
      • Demonstrated knowledge of FDA GMPs, ISO 9001, ISO 14971, ISO 13485, company policies and procedures, validation guidance, and other applicable standards.
      • Demonstrated ability to think strategically, lead technical teams, manage priorities, and collaborate across functions.

      Skills

      • Ability to use a computer, telephone, and general office equipment.
      • Strong computer skills and familiarity with Microsoft Office applications are required.

      Pay

      Salary Pay Range: $109,250.00 - $149,500.00 USD. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

      Benefits

      • Medical insurance
      • Dental insurance
      • Vision insurance
      • Life insurance
      • Short- and long-term disability
      • Business accident insurance
      • Group legal insurance
      • Savings plan (401(k))
      We omitted Schedule. Check for any duplicated lines: we didn't include EEO etc. Make sure no extra spaces at start. Now