Quality Engineer II
- .
- Pay: Not specified; no pay info. So we should NOT include Pay section.
- Schedule: Not specified; only mention on-site role, travel 0-5%. No schedule details like full-time, shift. So we should NOT include Schedule.
We also need to include location maybe as part of About the role? Could embed location in a
. The posting says "This is an on-site role in Memphis, TN." We'll include that. We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also remove the "*** This position is not eligible for employer based sponsorship. ***" maybe considered boilerplate? It's a sponsorship note; not sure if to remove. It's not EEO but maybe keep? It's a specific note about sponsorship; could be considered relevant. However instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. Sponsorship note is not exactly those; but could be considered legal? Might keep? Safer to keep? It's a substantive detail about sponsorship eligibility. I'd keep it as a short
maybe under About the role or separate? Probably include as a note. Also remove "The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment." etc. That's EEO boilerplate; remove. Also remove Colorado residents accommodation note etc. That's EEO/legal; remove. Also remove "If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5." That's accommodation instruction; remove. Also remove "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!" That's referral program; could be considered part of Benefits? It's about referral incentives; maybe keep under Benefits? It's not a benefit per se but could be considered. However it's more about application instruction; maybe remove as it's about referral before applying. Might be considered application instruction; remove. We need to preserve all substantive information; we should keep the referral program? It's not a benefit but maybe part of Benefits? The Benefits section already includes list; we could add referral program as a bullet? But the instruction says to include Benefits section only when posting has real specific content for it. It does have benefits list; we can include that. The referral program is separate; maybe we can keep as a note under Benefits? But it's not a benefit; it's a referral incentive. Could be considered part of Benefits? I'd keep it as a separate bullet under Benefits? Might be okay. But to be safe, I'd keep the referral program as a
under Benefits? However the instruction says "Prefer a few substantive sections over many thin ones." So maybe we can incorporate referral program into Benefits as a bullet. Now we need to deduplicate duties. Let's extract duties from the text: "Supports and provides direction to product development teams for the required quality deliverables." "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." (appears multiple times) "Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships." "A relentless focus on the safety and the efficacy of the medical device." (maybe part of previous) "Review and approve design verification and design validation protocols and reports. Ensure design activities prove design inputs and user needs are adequately addressed." "Leads and provides support on risk management 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. Perform Predicate Device reviews and surveillance reports. Able to perform data mining, analyze data and create trend reports." "Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management." "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." "Travel Requirements (including international): 0-5%" "Support internal and external audits. Provide support for audit preparation activities. Participate in the back-room as needed." We need to ensure we keep all unique statements. Now Minimum Requirements: "B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 2+ years of medical device experience (or equivalent work experience), or M.S. and 1+ years of medical device experience." Preferred Requirements (list): "Must be able to interpret and apply Quality Systems Regulations and ISO quality requirements and stay abreast of new industry standards and concepts." "Knowledge of design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations." "Must be capable to plan schedules and to manage multiple projects simultaneously." "Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable." "Design for Six Sigma training is desired along with knowledge of statistical methodologies." "Involvement in back-room support process during external audits and/or inspections." "Experience reviewing design verification and design validation protocols." "Excellent communication, problem solving, organizational, and interpersonal skills are required." "Strong technical writing skills." "Works independently with minimal direction or supervision." "Decision intelligence." Physical Requirements: "Ability to sit/stand for 8 hours." "Ability to sit at a computer terminal for an extended period." ADA Disclosure: we can keep as a short note? It's legal boilerplate but maybe we keep as it's about accommodations? The instruction says remove EEO/equal-opportunity/legal boilerplate. ADA disclosure is legal; maybe remove. However it's a statement about accommodations; could be considered boilerplate. I'd remove it. Now Benefits list: "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!" (maybe) Now we need to output HTML fragment with headings
and content. Structure:
About the role
... (including location, on-site, sponsorship note maybe)
Responsibilities
- ... each duty
Requirements
Minimum Requirements: B.S. degree ...
Qualifications
- Preferred requirements items...
Skills
- Excellent communication, problem solving, organizational, and interpersonal skills are required.
- Strong technical writing skills.
- Works independently with minimal direction or supervision.
- Decision intelligence.
. But we have no heading for Physical Requirements; we could add under Requirements as a note. Travel Requirements: 0-5% could be included under About the role or Responsibilities? Probably under About the role as a note. Now we need to ensure we don't include any boilerplate like EEO, etc. Now produce HTML. Let's craft About the role paragraph: "The Sustaining Quality Engineer is responsible for supporting all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining activities. The Sustaining Quality Engineer will serve as the quality engineering contact and be a key member of the cross-functional development and sustaining teams. The Sustaining Quality Engineer serves as the key resource for ensuring compliance to ISO, EU MDR, and FDA QSR requirements for Medical Devices. The Sustaining Quality Engineer takes the lead with quality initiatives with inter-organizational impact following QSR, CONMED Policies, standards and regulations. Works under direction from Quality Management. This is an on-site role in Memphis, TN. Travel requirements (including international