Quality Engineer
Katalyst CRO · Cincinnati, OH · 1 mo ago
On-siteQuality AssuranceContract
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. The posting is a summary of a candidate? Actually it's a job posting? It's a summary of a candidate? It says "Summary Quality Engineer with 5+ years of experience..." It's like a resume summary. But we need to treat as job posting? The content includes responsibilities, required skills, qualifications, etc. We need to extract sections.
We need to avoid repeating job title as heading. No Job ID. Remove boilerplate.
We need to preserve all substantive info.
Let's parse content:
"Summary Quality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives."
Then "Roles & Responsibilities Experience in a GMP and/or ISO regulated medical industry is required.Ability to analyze and present data that facilitates & drives decision making is required.The ability to perform "hands on" troubleshooting and problem solving is required Experience working in an FDA regulated environment is preferred.Experience working in operations supporting a production environment is preferred Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferredTechnical understanding of manufacturing equipment and processes is preferred Process Validation expertise is preferred.Ability to read and interpret CMM and dimensional inspection reports.Experience with dimensional data analysis utilizing software (Excel or Minitab)Experience in Medical Standards and Quality process preferred.New product launch experience from through full validation and commercial launchExperience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control PlanEnsures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.Performance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.Strong communication skills and ability to work well within a multidisciplinary team.Proficient with GD&T and interpreting technical drawings.Green or Black Belt Six Sigma certification preferred."
Then "Required Skills Process Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R)Statistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab)Medical Device Quality Systems (GMP, ISO 13485, FDA Compliance)Bachelor in Mechanical Engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required.Required medical domain experience. Surgical Product and Implants experience preferred."
We need to create sections: About the role (maybe summary), Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We have no explicit Benefits, Pay, Schedule info. So we should not include those sections.
We have summary paragraph: could be About the role.
Responsibilities: The block after "Roles & Responsibilities" includes many items that are responsibilities/requirements. Might split into Responsibilities and Requirements.
Qualifications: education, experience, certifications.
Skills: technical skills list.
We need to preserve all substantive info, not invent.
Let's extract:
About the role: The initial summary sentence(s). Could be: "Quality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives."
Responsibilities: The list after "Roles & Responsibilities" includes many items that are responsibilities: "Experience in a GMP and/or ISO regulated medical industry is required." Actually that sounds like requirement. But we can treat as responsibilities: "Ability to analyze and present data that facilitates & drives decision making", "Perform hands-on troubleshooting and problem solving", "Experience working in an FDA regulated environment (preferred)", "Experience working in operations supporting a production environment (preferred)", "Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (Measurement System Analysis, SPC, DOEs, Reliability, etc.) (preferred)", "Technical understanding of manufacturing equipment and processes (preferred)", "Process Validation expertise (preferred)", "Ability to read and interpret CMM and dimensional inspection reports", "Experience with dimensional data analysis utilizing software (Excel or Minitab)", "Experience in Medical Standards and Quality process (preferred)", "New product launch experience from through full validation and commercial launch", "Experience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control Plan", "Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.", "Performance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.", "Strong communication skills and ability to work well within a multidisciplinary team.", "Proficient with GD&T and interpreting technical drawings.", "Green or Black Belt Six Sigma certification preferred."
We need to keep all info, but we can combine similar items.
Requirements: maybe the mandatory items: "Bachelor in Mechanical Engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required." Also "Required medical domain experience." "Surgical Product and Implants experience preferred." Actually that is preferred.
But we can separate Requirements (must have) vs Qualifications (education, certifications). However the instruction says we can have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what goes where.
We have:
- About the role: summary paragraph.
- Responsibilities: duties (what the role will do). Many items are responsibilities.
- Requirements: mandatory experience/education.
- Qualifications: maybe certifications, preferred qualifications.
- Skills: technical skills list.
But we need to avoid duplication. Let's parse the "Required Skills" block: "Process Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R) Statistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab) Medical Device Quality Systems (GMP, ISO 13485, FDA Compliance) Bachelor in Mechanical Engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required. Required medical domain experience. Surgical Product and Implants experience preferred."
That seems like a mix of skills and requirements.
We could treat:
- Skills: Process Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R); Statistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab); Medical Device Quality Systems (GMP, ISO 13485, FDA Compliance); GD&T interpretation; dimensional data analysis; root cause investigation; new product commercialization; communication; multidisciplinary team; etc.
- Requirements: Bachelor in Mechanical Engineering or equivalent; minimum 5 years' experience as Quality/Validation/Manufacturing Engineering in medical product industry; required medical domain experience.
- Qualifications: Green or Black Belt Six Sigma certification preferred; experience with PFMEA/DFMEA, Gage R&R, TMV, Risk Assessments, Control Plan; new product launch experience; etc.
But we need to avoid duplication.
Let's create sections:
About the role
Quality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives.
Responsibilities
- Analyze and present data to facilitate and drive decision making.
- Perform hands-on troubleshooting and problem solving.
- Work in FDA-regulated environments (preferred).
- Support operations in a production environment (preferred).
- Apply advanced technical training and experience using Statistics, Lean and Six Sigma methodologies (Measurement System Analysis, SPC, DOE, Reliability, etc.) (preferred).
- Demonstrate technical understanding of manufacturing equipment and processes (preferred).
- Provide process validation expertise (preferred).
- Read and interpret CMM and dimensional inspection reports.
- Conduct dimensional data analysis using software (Excel or Minitab).
- Apply medical standards and quality processes (preferred).
- Lead new product launch from full validation through commercial launch.
- Develop and maintain PFMEA/DFMEA, Gage R&R, TMV, risk assessments, and control plans.
- Ensure corrective actions meet reliability standards and documentation complies with requirements.
- Perform performance component qualification (process characterization, process capability analysis, test method validation, IQ, OQ, PQ, FAI) for new supplier-manufactured components.
- Communicate effectively and work within multidisciplinary teams.
- Interpret GD&T and technical drawings.
- Maintain Green or Black Belt Six Sigma certification (preferred).
Requirements
- Bachelor’s degree in Mechanical Engineering or equivalent.
- Minimum 5 years’ experience working as a Quality, Validation, or Manufacturing Engineer in a medical product industry.
- Required medical domain experience.
Qualifications
- Surgical product and implants experience (preferred).
- Green Belt or Black Belt Six Sigma certification (preferred).
- Experience with PFMEA/DFMEA, Gage R&R, TMV, risk assessments, and control plans (preferred).
- New product launch experience from validation through commercial launch (preferred).
Skills
- Process validation (IQ/OQ/PQ, TMV, PFMEA, Gage R&R).
- Statistical analysis and Six Sigma (SPC, DOE, MSA, Minitab).
- Medical device quality systems (GMP, ISO 13485, FDA compliance).
- GD&T interpretation and technical drawing reading.
- Dimensional data analysis (Excel, Minitab).
- Root cause investigation.
- New product commercialization.
- Strong communication and cross‑functional collaboration.