Quality Systems Engineer

We need to output HTML fragment with sections: About the role? Actually the posting includes "About Cretex Medical" then "Position Summary". The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading. We need to include sections only when posting has real specific content. So we need to parse the posting. Content: - About Cretex Medical (company description). Could be "About the role"? Actually "About Cretex Medical" is company overview. Could map to "About the role"? The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can use "About the role" for description of role? But we have "Position Summary". That could be "About the role". We'll include an

About the role

with the Position Summary paragraph(s). Also we have "About Cretex Medical" which is company description; maybe we can include as part of About the role or separate? The instruction says use those headings; we could also include "About Cretex Medical" as a paragraph under About the role? But we need to preserve all substantive info. Could add a

about Cretex Medical before the role summary. Probably better to have a section "About the role" containing both company overview and position summary? However the heading "About the role" suggests role description, not company. But we can still include company overview as a paragraph inside that section. Or we could create a separate heading like "About Cretex Medical" but that's not in the allowed list. The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says use those for section headings. Likely they expect us to use those specific headings when applicable. So we should map content to those headings. Thus: - About the role: includes company overview and position summary. - Responsibilities: list of duties (the bullet-like sentences after "This position will be tasked with direct facilitation..." etc). Many responsibilities listed. - Requirements: education, experience, etc. The bullet list after "Ability to work in a manufacturing environment" includes Bachelor's Degree etc. Also "Ability to travel up to 15%". Could be requirements. - Qualifications: maybe overlapping with requirements; but we can separate: Qualifications could be the degree, experience, knowledge, etc. Skills could be technical skills: Microsoft Office proficiency, communication, attention to detail, organizational skills, ability to prioritize, multitask, etc. Benefits: described later: 401k, health clinics, etc. Pay: salary range. Schedule: maybe not given; no explicit schedule info besides maybe full-time? Not given, so we omit Schedule. We must not include boilerplate like EEO, E-Verify, etc. Remove those. We must not include duplicated lines. We need to preserve all substantive info; do not invent or summarize away detail. We need to output only HTML fragment. Let's extract content. First, company overview: "About Cretex Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com." We can keep that as a paragraph. Position Summary: "The Quality Systems Engineer will be responsible for providing core quality business process support & administration enabling enterprise level compliance. This position is responsible for ensuring a compliant Quality Management system including analysis, development, and revision of QMS processes, performing monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards. This position will be tasked with direct facilitation and administration of core business processes to include Engineering/Document Change Orders, CAPA, Management Review, Standards Library, Internal Audit, New Customer Audit, Regulatory Audit, and QMS/Regulatory Training. Identify, develop, and maintain relevant QMS programs to promote quality awareness and ensure compliance to company policies and procedures includingEngineering & Document Changes Corrective & Preventive ActionStandards Library AdministrationInternal Audit Management Customer Audit ManagementRegulatory Audit managementFacilitating QMS & Regulatory Training Management Lead internal, external and supplier audits, including audit preparation, execution, reporting and follow-up activitiesManage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions Assist in the definition of and continuous improvement of quality system business processes compliant to requirements outlined in ISO 9001, ISO 13485, and/or FDA QSR.Active participation in internal audits associated to ISO 9001, ISO 13485, and/or FDA QSR regulatory standards.Technical content writer of new and/or revising procedure/policy content within scope of the quality system.Analyze data and identify improvement opportunities.Support audit activities such as closing out audit findings, creating audit finding reports and collaborating on determining the proper corrective and preventative actions.Implement, monitor, lead and assist Corrective and Preventive Actions (CAPAs) that result from second, third-party, and internal audits.Technical contributor to initiatives associated toBusiness intelligence reporting and dashboard design & validation.Enterprise business workflow design & administrationQuality system business process automation through software based systems.Ensure business systems are supported, maintained, and functioning to defined requirements.Support and comply with the company Quality System, ISO, and medical device requirementsRead, understand, and follow work instructions and standard workParticipate in required company meetings Maintain an organized work area (5S)Participate in the Operational Excellence Program Complete all other work duties as assignedAbility to work in a manufacturing environment" That's a huge block; we need to split into responsibilities list. Let's parse responsibilities sentences: - providing core quality business process support & administration enabling enterprise level compliance. - ensuring a compliant Quality Management system including analysis, development, and revision of QMS processes, performing monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards. - direct facilitation and administration of core business processes to include Engineering/Document Change Orders, CAPA, Management Review, Standards Library, Internal Audit, New Customer Audit, Regulatory Audit, and QMS/Regulatory Training. - Identify, develop, and maintain relevant QMS programs to promote quality awareness and ensure compliance to company policies and procedures including - Engineering & Document Changes - Corrective & Preventive Action - Standards Library Administration - Internal Audit Management - Customer Audit Management - Regulatory Audit management - Facilitating QMS & Regulatory Training Management - Lead internal, external and supplier audits, including audit preparation, execution, reporting and follow-up activities - Manage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions - Assist in the definition of and continuous improvement of quality system business processes compliant to requirements outlined in ISO 9001, ISO 13485, and/or FDA QSR. - Active participation in internal audits associated to ISO 9001, ISO 13485, and/or FDA QSR regulatory standards. - Technical content writer of new and/or revising procedure/policy content within scope of the quality system. - Analyze data and identify improvement opportunities. - Support audit activities such as closing out audit findings, creating audit finding reports and collaborating on determining the proper corrective and preventative actions. - Implement, monitor, lead and assist Corrective and Preventive Actions (CAPAs) that result from second, third-party, and internal audits. - Technical contributor to initiatives associated to - Business intelligence reporting and dashboard design & validation. - Enterprise business workflow design & administration - Quality system business process automation through software based systems. - Ensure business systems are supported, maintained, and functioning to defined requirements. - Support and comply with the company Quality System, ISO, and medical device requirements - Read, understand, and follow work instructions and standard work - Participate in required company meetings - Maintain an organized work area (5S) - Participate in the Operational Excellence Program - Complete all other work duties as assigned - Ability to work in a manufacturing environment Now requirements/qualifications: After that block we see: "Ability to work in a manufacturing environmentBachelor’s Degree in Computer Science, Software Engineering, Programming, or related STEM certified program.5+ years of experience working with quality management systems in regulated environment (ISO 13485, EUMDR, FDA)Knowledge of quality systems, regulatory requirements, and industry standardsAcademic experience with business intelligence software toolsAbility to consistently achieve short and long-term business resultsMicrosoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)Clear and effective verbal and written communication skills Attention to detailOrganizational skills Ability to work in a fast-paced team environmentAbility to prioritize and multitaskAbility to travel up to 15%" We need to separate into Requirements (education, experience) and Qualifications (knowledge, skills) and Skills (technical, soft). But we can combine. Let's extract: Education: Bachelor’s Degree in Computer Science, Software Engineering, Programming, or related STEM certified program. Experience: 5+ years of experience working with quality management systems in regulated environment (ISO 13485, EUMDR, FDA) Knowledge: Knowledge of quality systems, regulatory requirements, and industry standards Academic experience with business intelligence software tools Ability to consistently achieve short and long-term business results Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher) Clear and effective verbal and written communication skills Attention to detail Organizational skills Ability to work in a fast-paced team environment Ability to prioritize and multitask Ability to travel up to 15% We could treat "Ability to work in a manufacturing environment" as a requirement. Now Benefits section: After "What is it like to work at Cretex Medical?" we have paragraphs: "We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement. Here are some of things that employees have said about working for Cretex Medical “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.” “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.” “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.” We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member." Then pay range: "USD $75,000.00 - USD $112,600.00 /Yr. This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range." Then benefits details: "All Employees Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours Cretex’s medical benefit package includes comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services