Sr Manager Quality Engineering

We need to output HTML fragment with sections: About the role? The posting includes description of responsibilities etc. We need headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We have responsibilities (Key Duties And Responsibilities). We have Minimum Requirements and Preferred Requirements (these could be Requirements and Qualifications). Benefits are described. Pay and Schedule not mentioned (no pay, schedule). So we should not include Pay or Schedule sections. Also we should not include About the role unless we have a summary; we could treat the first paragraph as About the role. The first paragraph: "The Sr. Manager Quality Engineering is responsible for supporting all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining activities. The Quality Engineering function serves as the main quality contact and is a key member of the cross-functional development and sustaining teams. The role serves as the key resource for ensuring compliance to applicable regulatory requirements and quality management system processes." That's about the role. So we can have

About the role

with that paragraph. Responsibilities: list of duties. We need to extract bullet points from the "Key Duties And Responsibilities" paragraph. It's a long paragraph with many sentences. We need to convert to

• items. We must preserve all substantive information, not invent or summarize away detail. So we need to break each duty into separate list items. However we must not lose any detail. The paragraph contains many duties separated by periods. We can split by sentences. Let's extract sentences: 1. Foster and sustain a culture of quality that prioritizes patient safety, product reliability, and regulatory compliance. 2. Partner with cross-functional teams to ensure quality is embedded in all aspects of product development and manufacturing, enabling our customers to confidently care for the patients who depend on our products. 3. Supports and provides direction to product development teams for the required quality deliverables. 4. Manage quality resource allocation and workload to support assigned projects. 5. Ensures that product design meets customer expectations, regulatory requirements, appropriate voluntary standards, and all corporate requirements. 6. Shows focus toward continuous improvement. 7. Review, assess, and approve product design documentation to ensure compliance throughout product development cycle. 8. Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability. 9. Write, review, and approve design verification and design validation protocols and reports. 10. Ensure design activities prove design inputs and user needs are adequately addressed. 11. Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships. 12. Act as a mentor for employees. Be the first level resource for employees and encourage continuous improvement. 13. Ensure application of the risk management process throughout all activities with a focus on clinician and patient safety. 14. Support product development through capability assessment, analyzing performance data, facilitating problem-solving activities, developing quality tools, and quality techniques. 15. Support sustaining activities such as complaint investigation and complaint trending. 16. Monitor and analyze manufacturing and service trends. 17. Able to perform data mining, analyze data and create trend reports. 18. Investigates process and product issues identified through complaints and trend analysis of other conformance data. 19. Works with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations. 20. Direct and facilitate investigations and the corresponding preventative actions and corrective actions that result from abnormal results, customer complaints, quality inquiries, and other quality performance indicators. 21. Support internal audits. 22. Provide support for audit preparation activities. 23. Provide oversight and guidance for back-room activities. We need to ensure we didn't miss any. Also there is "Supports and provides direction to product development teams for the required quality deliverables." Already captured. Now Requirements: Minimum Requirements: B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 8+ years of medical device experience (or equivalent work experience); Travel Requirements (including international): 0-15%; Minimum of 2 years of supervisory experience. We could put these as list items under Requirements. Preferred Requirements: Deep understanding of new product development, design controls, risk management, supplier management, and compliance to applicable regulatory requirements for medical device manufacturing.; Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.; Design for Six Sigma training is desired along with knowledge of statistical methodologies. We could put these under Qualifications or Skills. The spec says we can use sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide where to put each. Minimum Requirements could be Requirements. Preferred Requirements could be Qualifications. Skills maybe not explicitly listed; we could omit Skills if no specific skill list. Benefits we have. We must not include sections with filler like "commensurate with experience". Benefits section: we have list of benefits. We need to extract them. Benefits paragraph: "CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information. Competitive compensationExcellent healthcare including medical, dental, vision and prescription coverageShort & long term disability plus life insurance -- cost paid fully by CONMEDRetirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay periodEmployee Stock Purchase Plan -- allows stock purchases at discounted priceTuition assistance for undergraduate and graduate level courses Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!" We need to preserve all substantive information. Remove fluff like "Visit our Benefits Page for more information." That's maybe boilerplate? It's not EEO but it's a generic link; could be considered navigation? It's not essential but it's not prohibited. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. "Visit our Benefits Page for more information." is not exactly navigation but could be considered a link; but it's not essential. Might be safe to keep? It's not prohibited. However we might keep it as part of benefits description. But better to keep substantive benefits only. The phrase "Visit our Benefits Page for more information." is not a benefit; it's a call to action. Could be considered application instruction? Not exactly. I'd keep it maybe as a p. But we can drop it to keep concise. We need to list benefits as
  • . Let's extract: - Competitive compensation - Excellent healthcare including medical, dental, vision and prescription coverage - Short & long term disability plus life insurance -- cost paid fully by CONMED - Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period - Employee Stock Purchase Plan -- allows stock purchases at discounted price - Tuition assistance for undergraduate and graduate level courses - Employee Referral Program incentives (if referred) We should keep the referral program as a benefit. Now we need to output HTML fragment only, no /. Use

    for headings. Use

    for prose. Use

    • for lists. We need to ensure we don't repeat job title as heading. We already have About the role. We must not include Pay or Schedule sections. Now construct:

      About the role

      The Sr. Manager Quality Engineering is responsible for supporting all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining activities. The Quality Engineering function serves as the main quality contact and is a key member of the cross-functional development and sustaining teams. The role serves as the key resource for ensuring compliance to applicable regulatory requirements and quality management system processes.

      Responsibilities

      • Foster and sustain a culture of quality that prioritizes patient safety, product reliability, and regulatory compliance.
      • Partner with cross-functional teams to ensure quality is embedded in all aspects of product development and manufacturing, enabling our customers to confidently care for the patients who depend on our products.
      • Supports and provides direction to product development teams for the required quality deliverables.
      • Manage quality resource allocation and workload to support assigned projects.
      • Ensures that product design meets customer expectations, regulatory requirements, appropriate voluntary standards, and all corporate requirements.
      • Shows focus toward continuous improvement.
      • Review, assess, and approve product design documentation to ensure compliance throughout product development cycle.
      • Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
      • Write, review, and approve design verification and design validation protocols and reports.
      • Ensure design activities prove design inputs and user needs are adequately addressed.
      • Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
      • Act as a mentor for employees. Be the first level resource for employees and encourage continuous improvement.
      • Ensure application of the risk management process throughout all activities with a focus on clinician and patient safety.
      • Support product development through capability assessment, analyzing performance data, facilitating problem-solving activities, developing quality tools, and quality techniques.
      • Support sustaining activities such as complaint investigation and complaint trending.
      • Monitor and analyze manufacturing and service trends.
      • Able to perform data mining, analyze data and create trend reports.
      • Investigates process and product issues identified through complaints and trend analysis of other conformance data.
      • Works with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations.
      • Direct and facilitate investigations and the corresponding preventative actions and corrective actions that result from abnormal results, customer complaints, quality inquiries, and other quality performance indicators.
      • Support internal audits.
      • Provide support for audit preparation activities.
      • Provide oversight and guidance for back-room activities.

      Requirements

      • B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 8+ years of medical device experience (or equivalent work experience)
      • Travel Requirements (including international): 0-15%
      • Minimum of 2 years of supervisory experience

      Qualifications

      • Deep understanding of new product development, design controls, risk management, supplier management, and compliance to applicable regulatory requirements for medical device manufacturing.
      • Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.
      • Design for Six Sigma training is desired along with knowledge of statistical methodologies.

      Benefits

      • Competitive compensation
      • Excellent healthcare including medical, dental, vision and prescription coverage
      • Short & long term disability plus life insurance -- cost paid fully by CONMED
      • Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
      • Employee Stock Purchase Plan -- allows stock purchases at discounted price
      • Tuition assistance for undergraduate and graduate level courses
      • Employee Referral Program incentives (if referred)
      We should not include any extra text. Ensure no markdown fences. Output only HTML. Check for any duplicated lines: none. Check for any boilerplate: we removed EEO etc. The original had EEO statements etc. We removed them. Check for any mention of Pay or Schedule: none. All good. Now output.