Quality Engineer III

Thermo Fisher Scientific · Middletown, VA · 4 wk ago

On-siteQuality Assurance$76k–$114k/yrFull-time

We need to output HTML fragment with sections: h3 for headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include only sections with real content. The posting includes: Work Schedule Standard (Mon-Fri) Environmental Conditions ... etc. Also includes description of role. There's a "Compensation And Benefits" section with salary range and benefits. There's also "Work Schedule Standard (Mon-Fri)" which is schedule info. There's also environmental conditions etc. We need to decide sections. We have: About the role (description). Responsibilities (list of duties). Requirements (education/experience). Qualifications (maybe certifications). Skills (list of skills). Benefits (benefits). Pay (salary range). Schedule (work schedule). Also maybe "Environmental Conditions" could be part of responsibilities or a separate section? But we only have allowed headings list; we can't create new headings not in list. So we must fit content into those headings. Environmental conditions could go under Responsibilities or maybe under Requirements? Probably under Responsibilities as part of job duties (adherence to GMP, cleanroom, PPE). Work schedule is schedule. We need to avoid duplicating lines, remove boilerplate like relocation assistance not provided, pre-employment screening, etc? The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Relocation assistance not provided is not boilerplate? It's a detail about the job; maybe keep? It's not EEO. It's a minor metadata; could be folded into short p or drop. Probably we can drop it as not essential. Also "Must be able to satisfy applicable pre-employment screening requirements" is boilerplate; drop. We need to preserve all substantive information. So we keep description, responsibilities list, requirements, qualifications (certifications), skills list, benefits list, pay range, schedule. We must not invent or summarize away detail. So we need to keep specifics like salary range $75,800.00–$113,675.00, bonus eligibility, benefits details: medical/dental/vision, EAP, commuter benefits, tuition reimbursement, at least 120 hours PTO, 10 paid holidays, paid parental leave (3 weeks bonding, 8 weeks caregiver), accident and life insurance, short- and long-term disability, retirement 401(k), ESPP. We need to format as

for any list of duties/requirements/benefits. For prose use
. We need headings
. Use only those headings that have real content. Let's craft sections:
About the role

As a Quality Engineer III, you'll help ensure quality excellence and regulatory compliance across manufacturing operations. You'll help ensure our products meet the highest standards while supporting our mission to enable customers to make the world healthier, cleaner and safer. This role combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, support process validation and remediation activities, drive continuous improvement, and ensure GMP/ISO compliance. You'll work with multiple teams to resolve quality issues, conduct risk assessments, manage CAPAs, support validation and remediation programs, support audits, and implement quality initiatives. The role requires strong analytical and communication skills to interface effectively with internal teams and external customers/regulators. You'll help establish and maintain quality standards while supporting a culture of continuous improvement and compliance. This position is based in Middletown, VA.
That covers description.
Responsibilities
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Cleanroom requirements: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc.
- Use of required PPE (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
- Help ensure quality excellence and regulatory compliance across manufacturing operations
- Maintain robust quality management systems
- Lead investigations
- Support process validation and remediation activities
- Drive continuous improvement
- Ensure GMP/ISO compliance
- Work with multiple teams to resolve quality issues
- Conduct risk assessments
- Manage CAPAs
- Support validation and remediation programs
- Support audits
- Implement quality initiatives
- Interface effectively with internal teams and external customers/regulators
- Establish and maintain quality standards
- Support a culture of continuous improvement and compliance
But we might be duplicating some items already in description. However we need to preserve all substantive info; we can include them but avoid duplication? The instruction: Remove duplicated lines. So we should not repeat same sentence exactly. The description already includes many of those responsibilities. To avoid duplication, we could keep description as prose and responsibilities as a concise list of core duties not already covered. But it's tricky. Perhaps better to keep description as overview and responsibilities as bullet list of specific duties: ensuring GMP, cleanroom, PPE, lead investigations, manage CAPAs, support validation, support audits, implement quality initiatives, conduct risk assessments, interface with teams, establish quality standards, drive continuous improvement. That seems okay. We'll try to avoid repeating exact phrases from description. Let's craft responsibilities list focusing on specific actions.
Requirements

Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance within a regulated industry, such as pharmaceutical, medical device, or biotech.

Qualifications
- Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field
- ASQ certifications (CQE, CQA) desired
- Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)
- Experience with process validation, including protocol execution, process qualification, continued process verification, and validation deviation management
- Experience leading quality and compliance remediation, including gap assessments, corrective actions, effectiveness checks, and remediation plans
- Expertise in quality systems, including: CAPA and deviation management, Change control, Risk management and FMEA, Document control, Internal and external auditing
But note "Expertise in quality systems, including:" is a heading inside list; we can keep as part of list item with sub-items? Might be better to break into separate list items. We'll keep as separate items.
Skills
- Advanced problem-solving and root cause analysis skills
- Excellent project management skills
- Strong verbal and written communication skills
- Proficiency with quality management software and MS Office
- Experience with equipment, process, and cleaning validation
- Knowledge of statistical analysis, process capability, trending, and quality tools
- Ability to work independently and collaboratively
- Strong attention to detail and broad perspective
- Excellent cross-functional collaboration skills
- May require up to 25% travel
- Additional language skills may be beneficial
But "May require up to 25% travel" and "Additional language skills may be beneficial" are more like requirements/notes; still okay.
Benefits
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually
- Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
- Accident and life insurance
- Short- and long-term disability
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Pay

The salary range estimated for this position based in Virginia is $75,800.00–$113,675.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Schedule

Work Schedule Standard (Mon-Fri)
We also have environmental conditions: Cleanroom, PPE etc. Already included in responsibilities. We need to ensure we didn't include any boilerplate like "Relocation assistance is not provided." We omitted. Also omitted pre-employment screening. Check for duplicated lines: Ensure no exact repeats. The description includes "help ensure quality excellence and regulatory compliance across manufacturing operations" which also appears in responsibilities? We didn't include that exact phrase in responsibilities list; we have "Help ensure quality excellence and regulatory compliance across manufacturing operations" as a bullet? Actually we didn't include that; we omitted. Good. Check responsibilities list: we have items like "Adherence to all Good Manufacturing Practices (GMP) Safety Standards", "Cleanroom requirements: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc.", "Use of required PPE (safety glasses, gowning, gloves, lab coat, ear plugs etc.)", "Help ensure quality excellence and regulatory compliance across manufacturing operations" - wait we didn't include that? I think we omitted. Let's verify: In responsibilities list we wrote: - Adherence to all Good Manufacturing Practices (GMP) Safety Standards - Cleanroom requirements: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. - Use of required PPE (safety glasses, gowning, gloves, lab coat, ear plugs etc.) - Help ensure quality excellence and regulatory compliance across manufacturing operations - Maintain robust quality management systems - Lead investigations - Support process validation and remediation activities - Drive continuous improvement - Ensure GMP/ISO compliance - Work with multiple teams to resolve quality issues - Conduct risk assessments - Manage CAPAs - Support validation and remediation programs - Support audits - Implement quality initiatives - Interface effectively with internal teams and external customers/regulators - Establish and maintain quality standards - Support a culture of continuous improvement and compliance We included "Help ensure quality excellence and regulatory compliance across manufacturing operations" which is exactly from description. That's a duplicate line. We need to remove that line to avoid duplication. Also "Maintain robust quality management systems" appears in description? Description: "This role combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, support process validation and remediation activities, drive continuous improvement, and ensure GMP/ISO compliance." So "Maintain robust quality management systems" is also duplicate. "Lead investigations" duplicate. "Support process validation and remediation activities" duplicate. "Drive continuous improvement" duplicate. "Ensure GMP/ISO compliance" duplicate. "Work with multiple teams to resolve quality issues" duplicate? Description: "You'll work with multiple teams to resolve quality issues, conduct risk assessments, manage CAPAs, support validation and remediation programs, support audits, and implement quality initiatives." So that's duplicate. "Conduct risk assessments" duplicate. "Manage CAPAs" duplicate. "Support validation and remediation programs" duplicate. "Support audits" duplicate. "Implement quality initiatives" duplicate. "Interface effectively with internal teams and external customers/regulators" duplicate? Description: "The role requires strong analytical and

Quality Engineer III

. Use only those headings that have real content. Let's craft sections:

About the role

Responsibilities

Requirements

Qualifications

Skills

Benefits

Pay

Schedule

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