Senior Supplier Quality Engineer
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to preserve all substantive information; do not invent or at least not lose details. We'll need to include the details from the description.
Let's extract content.
First, "Your Role" paragraph: "Serves as the primary Supplier Quality Engineering point of contact for the Colorado Springs, CO facility, providing on-site support ensuring timely alignment with site Quality, Manufacturing, R&D, Sustaining Engineering, Procurement, and supplier stakeholders."
Then bullet list of responsibilities (starting with "Leads and owns MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ, and related APQP / PPAP activities..." etc). We'll need to capture each bullet.
Let's list them:
- Leads and owns MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ, and related APQP / PPAP activities to ensure supplier process capability, validation readiness, and compliance with quality requirements.
- Leads APQP / PPAP execution for supplier transfers, supplier changes, SICRs, and sustaining projects supporting the Fremont, CA manufacturing facility.
- Facilitates Design for Excellence collaboration between R&D, Sustaining Engineering, Manufacturing, and suppliers to improve design quality, manufacturability, supplier process robustness, and long-term product performance.
- Ensures Critical to Quality characteristics are clearly defined, flowed down to suppliers, validated through appropriate controls, and maintained throughout production.
- Leads supplier audits, including initial qualification, for-cause, and follow-up audits, to assess supplier compliance with applicable quality system requirements, regulatory expectations, process controls, and supplier agreement obligations.
- Leads supplier qualification activities for addition to the Approved Supplier List, including supplier capability assessment, quality system maturity evaluation, technical readiness, risk classification, approval documentation, and onboarding completion.
- Leads supplier-related non-conformance investigations, including defect analysis, supplier-cause determination, containment, risk assessment, escalation, and disposition support.
- Initiates, coordinates, and manages Supplier Corrective Action Requests, ensuring effective root cause analysis, corrective/preventive action implementation, verification of effectiveness, and timely closure.
- Drives systemic supplier improvement using supplier performance data, NC trends, audit outcomes, SCAR history, defect recurrence, and process capability indicators.
Now "You're The Right Fit If You" bullet points:
- You have a minimum of 5+ years' experience in Supplier Quality Engineering within FDA regulated medical device (Class II & III) manufacturing/supplier environments.
- You have strong experience in supplier selection, performance assessment, Risk Assessments/PFMEA’s, SPC, SCAR’s, SICR, CAPA, and related APQP/PPAP activities.
- You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282).
- You have proven experience utilizing data analytics/KPI’s to assess supplier performance and identify/drive process improvement opportunities.
- You have strong communications skills and the proven ability to effectively influence and build relationships cross-functionally with a variety of internal/external stakeholders, suppliers, Regulatory Agencies, Notified Bodies etc.
- You have a Bachelors Degree in Mechanical, Electrical, Biomedical, or Industrial Engineering, or related technical discipline.
- ASQ and/or Six Sigma DfX Certifications-Desired.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
We might treat the last bullet as a generic statement; but it's still substantive? It says must be able to perform minimum Physical, Cognitive and Environmental job requirements. That's vague; but it's still a requirement. However we might not want to include filler like "with or without accommodation". It's not placeholder. It's a requirement but vague. We could include it under Requirements or Qualifications. But we need to avoid sections with filler like "commensurate with experience". This is not filler; it's a requirement but generic. I'd include it.
Now "How We Work Together": "We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence (5 days per week) in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Onsite role."
We can extract schedule: Onsite role, 5 days per week.
Now "About Philips": "We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business.Discover our rich and exciting history.Learn more about our purpose.Learn more about our culture."
That's boilerplate marketing; maybe we can omit as it's not specific to role? The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This "About Philips" is generic corporate marketing; could be considered boilerplate? It's not EEO but it's generic. The instruction says preserve ALL substantive information; but "About Philips" is not substantive to the job? It's generic. Might be considered boilerplate. However it's not explicitly listed as boilerplate to remove, but it's not specific to the role. The instruction says "Prefer a few substantive sections over many thin ones." Might be okay to omit. But we need to preserve ALL substantive information; if we omit it, we might be losing some info but it's not crucial. I'd consider it safe to omit as it's generic fluff.
Now "Philips Transparency Details": includes pay range and benefits description.
- Pay range: $92,000 to $146,000.
- Additional compensation: annual incentive bonus, sales commission or long-term incentives may be offered.
- Benefits: comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
Also "Details about our benefits can be found here." (link) - we can omit link.
Now "Additional Information": US work authorization precondition, no sponsorship, no relocation benefits, must reside in or within commuting distance to Colorado Springs, CO. Travel up to 10%. Requisition active 45 days. EEO statement etc. We need to remove EEO/equal-opportunity boilerplate. Also remove "Interested candidates are encouraged to apply as soon as possible". That's application instruction; remove. Also "Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace." Remove.
We need to keep: US work authorization precondition, no sponsorship, no relocation benefits, must reside in or within commuting distance to Colorado Springs, CO, travel up to 10%. Those are substantive.
Where to place those? Could be under Requirements or maybe a separate section like "Additional Information". But we only have predefined headings; we could add them under Requirements or Qualifications. However the instruction says to use those headings only when posting has real specific content for it. We could add a section "Requirements" that includes experience, knowledge, etc. Also we could add "Qualifications" for education and certifications. "Skills" for communication, influence, data analytics. "Benefits" for benefits. "Pay" for pay range. "Schedule" for schedule.
The "Additional Information" like work authorization, location, travel could be placed under Requirements or maybe under a separate section like "Requirements". But we need to avoid creating new headings not in list. So we can incorporate them into Requirements or Qualifications.
Let's decide sections:
- About the role: prose from "Your Role" first sentence.
- Responsibilities: list of duties (the bullet points after "Your Role").
- Requirements: include experience (5+ years), strong experience in supplier selection etc., detailed knowledge of regulations, proven experience utilizing data analytics/KPIs, strong communications skills, ability to influence, Bachelors Degree, ASQ/Six Sigma certifications desired, ability to perform physical/cognitive/environmental requirements, US work authorization precondition, no sponsorship, must reside in/commuting distance to Colorado Springs, travel up to 10%.
But note that some of those are more like "Additional Information". However we can still put them under Requirements.
- Qualifications: maybe education and certifications? But we already included education in Requirements. To avoid duplication, we could separate: Requirements = experience and knowledge; Qualifications = education and certifications; Skills = communication, influence, data analytics; Benefits = benefits; Pay = pay range; Schedule = schedule.
Let's see if we have enough distinct content for each.
Experience and knowledge: 5+ years experience, strong experience in supplier selection etc., detailed knowledge of regulations, proven experience utilizing data analytics/KPIs.
Education: Bachelors Degree in Mechanical, Electrical, Biomedical, or Industrial Engineering, or related technical discipline.
Certifications: ASQ and/or Six Sigma DfX Certifications-Desired.
Skills: strong communications skills, proven ability to effectively influence and build relationships cross-functionally.
Also maybe "ability to perform physical/cognitive/environmental job requirements" could be under Requirements or Qualifications; but it's more a requirement.
We also have US work authorization, location, travel.
We could put those under Requirements as well.
Let's design:
About the role
Serves as the primary Supplier Quality Engineering point of contact for the Colorado Springs, CO facility, providing on-site support ensuring timely alignment with site Quality, Manufacturing, R&D, Sustaining Engineering, Procurement, and supplier stakeholders.
Responsibilities
for prose. We need to preserve all substantive information; do not invent or at least not lose details. We'll need to include the details from the description. Let's extract content. First, "Your Role" paragraph: "Serves as the primary Supplier Quality Engineering point of contact for the Colorado Springs, CO facility, providing on-site support ensuring timely alignment with site Quality, Manufacturing, R&D, Sustaining Engineering, Procurement, and supplier stakeholders." Then bullet list of responsibilities (starting with "Leads and owns MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ, and related APQP / PPAP activities..." etc). We'll need to capture each bullet. Let's list them: - Leads and owns MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ, and related APQP / PPAP activities to ensure supplier process capability, validation readiness, and compliance with quality requirements. - Leads APQP / PPAP execution for supplier transfers, supplier changes, SICRs, and sustaining projects supporting the Fremont, CA manufacturing facility. - Facilitates Design for Excellence collaboration between R&D, Sustaining Engineering, Manufacturing, and suppliers to improve design quality, manufacturability, supplier process robustness, and long-term product performance. - Ensures Critical to Quality characteristics are clearly defined, flowed down to suppliers, validated through appropriate controls, and maintained throughout production. - Leads supplier audits, including initial qualification, for-cause, and follow-up audits, to assess supplier compliance with applicable quality system requirements, regulatory expectations, process controls, and supplier agreement obligations. - Leads supplier qualification activities for addition to the Approved Supplier List, including supplier capability assessment, quality system maturity evaluation, technical readiness, risk classification, approval documentation, and onboarding completion. - Leads supplier-related non-conformance investigations, including defect analysis, supplier-cause determination, containment, risk assessment, escalation, and disposition support. - Initiates, coordinates, and manages Supplier Corrective Action Requests, ensuring effective root cause analysis, corrective/preventive action implementation, verification of effectiveness, and timely closure. - Drives systemic supplier improvement using supplier performance data, NC trends, audit outcomes, SCAR history, defect recurrence, and process capability indicators. Now "You're The Right Fit If You" bullet points: - You have a minimum of 5+ years' experience in Supplier Quality Engineering within FDA regulated medical device (Class II & III) manufacturing/supplier environments. - You have strong experience in supplier selection, performance assessment, Risk Assessments/PFMEA’s, SPC, SCAR’s, SICR, CAPA, and related APQP/PPAP activities. - You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282). - You have proven experience utilizing data analytics/KPI’s to assess supplier performance and identify/drive process improvement opportunities. - You have strong communications skills and the proven ability to effectively influence and build relationships cross-functionally with a variety of internal/external stakeholders, suppliers, Regulatory Agencies, Notified Bodies etc. - You have a Bachelors Degree in Mechanical, Electrical, Biomedical, or Industrial Engineering, or related technical discipline. - ASQ and/or Six Sigma DfX Certifications-Desired. - You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. We might treat the last bullet as a generic statement; but it's still substantive? It says must be able to perform minimum Physical, Cognitive and Environmental job requirements. That's vague; but it's still a requirement. However we might not want to include filler like "with or without accommodation". It's not placeholder. It's a requirement but vague. We could include it under Requirements or Qualifications. But we need to avoid sections with filler like "commensurate with experience". This is not filler; it's a requirement but generic. I'd include it. Now "How We Work Together": "We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence (5 days per week) in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Onsite role." We can extract schedule: Onsite role, 5 days per week. Now "About Philips": "We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business.Discover our rich and exciting history.Learn more about our purpose.Learn more about our culture." That's boilerplate marketing; maybe we can omit as it's not specific to role? The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This "About Philips" is generic corporate marketing; could be considered boilerplate? It's not EEO but it's generic. The instruction says preserve ALL substantive information; but "About Philips" is not substantive to the job? It's generic. Might be considered boilerplate. However it's not explicitly listed as boilerplate to remove, but it's not specific to the role. The instruction says "Prefer a few substantive sections over many thin ones." Might be okay to omit. But we need to preserve ALL substantive information; if we omit it, we might be losing some info but it's not crucial. I'd consider it safe to omit as it's generic fluff. Now "Philips Transparency Details": includes pay range and benefits description. - Pay range: $92,000 to $146,000. - Additional compensation: annual incentive bonus, sales commission or long-term incentives may be offered. - Benefits: comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Also "Details about our benefits can be found here." (link) - we can omit link. Now "Additional Information": US work authorization precondition, no sponsorship, no relocation benefits, must reside in or within commuting distance to Colorado Springs, CO. Travel up to 10%. Requisition active 45 days. EEO statement etc. We need to remove EEO/equal-opportunity boilerplate. Also remove "Interested candidates are encouraged to apply as soon as possible". That's application instruction; remove. Also "Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace." Remove. We need to keep: US work authorization precondition, no sponsorship, no relocation benefits, must reside in or within commuting distance to Colorado Springs, CO, travel up to 10%. Those are substantive. Where to place those? Could be under Requirements or maybe a separate section like "Additional Information". But we only have predefined headings; we could add them under Requirements or Qualifications. However the instruction says to use those headings only when posting has real specific content for it. We could add a section "Requirements" that includes experience, knowledge, etc. Also we could add "Qualifications" for education and certifications. "Skills" for communication, influence, data analytics. "Benefits" for benefits. "Pay" for pay range. "Schedule" for schedule. The "Additional Information" like work authorization, location, travel could be placed under Requirements or maybe under a separate section like "Requirements". But we need to avoid creating new headings not in list. So we can incorporate them into Requirements or Qualifications. Let's decide sections: - About the role: prose from "Your Role" first sentence. - Responsibilities: list of duties (the bullet points after "Your Role"). - Requirements: include experience (5+ years), strong experience in supplier selection etc., detailed knowledge of regulations, proven experience utilizing data analytics/KPIs, strong communications skills, ability to influence, Bachelors Degree, ASQ/Six Sigma certifications desired, ability to perform physical/cognitive/environmental requirements, US work authorization precondition, no sponsorship, must reside in/commuting distance to Colorado Springs, travel up to 10%. But note that some of those are more like "Additional Information". However we can still put them under Requirements. - Qualifications: maybe education and certifications? But we already included education in Requirements. To avoid duplication, we could separate: Requirements = experience and knowledge; Qualifications = education and certifications; Skills = communication, influence, data analytics; Benefits = benefits; Pay = pay range; Schedule = schedule. Let's see if we have enough distinct content for each. Experience and knowledge: 5+ years experience, strong experience in supplier selection etc., detailed knowledge of regulations, proven experience utilizing data analytics/KPIs. Education: Bachelors Degree in Mechanical, Electrical, Biomedical, or Industrial Engineering, or related technical discipline. Certifications: ASQ and/or Six Sigma DfX Certifications-Desired. Skills: strong communications skills, proven ability to effectively influence and build relationships cross-functionally. Also maybe "ability to perform physical/cognitive/environmental job requirements" could be under Requirements or Qualifications; but it's more a requirement. We also have US work authorization, location, travel. We could put those under Requirements as well. Let's design:
About the role
Serves as the primary Supplier Quality Engineering point of contact for the Colorado Springs, CO facility, providing on-site support ensuring timely alignment with site Quality, Manufacturing, R&D, Sustaining Engineering, Procurement, and supplier stakeholders.