New · posted Nov 10
Thermo Fisher Scientific · Medical Devices
Sr. QA Technician - 2nd Shift
- Frederick, MD
- On-site
- Full-time
- Senior & Principal
The role
Sr QA Technician
Location: Frederick, Maryland, United States of America Full time: Internal/External
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
What the job entails
- Review Device History Records (DHR’s) and associated documents to ensure that all documents and specifications are met. Identify non-conformances.
- Perform physical inspection of product to ensure compliance to packaging and labeling specifications.
- Ensures activities and items are in compliance with both company quality assurance standards and applicable quality system regulations. Help resolve incomplete or unexplained issues found during the batch review with manufacturing.
- Must be open to potential overtime work.
What you need
Education
- Associate degree in Scientific/Technical field with equivalent experience preferred.
- HS Diploma or GED required.
Experience
- Working experience in a regulated industry preferred.
Knowledge, Skills, Abilities
- Effective communication/interpersonal skills are required, both written and verbal.
What you'll do
How will you make an impact?
The Quality Assurance Specialist works as a member of the QA team at our Frederick, Maryland facility. This person’s core responsibility will be supporting our manufacturing team by reviewing manufacturing documentation, inspecting product on the manufacturing floor to ensure all requirements and specifications are met, generating product certificates, and releasing product for sale.
Pay
$47,008 – $70,533 a year
Employer provided$22.60 – $33.91 an hour · yearly at 2,080 hours (40 a week)
How this comparesThe hourly pay range estimated for this position based in Maryland is $22.60–$33.91.
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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
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, and short- and long-term disability in accordance with company policy
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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Starting pay at $26/hr + full time, competitive benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain five reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, tackle complex and in-depth scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Where you'll work
Frederick, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Frederick, MDSchedule and working conditions
Days
Hours
Second Shift (Afternoons)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Environmental Conditions
Office
Shift Information
Monday-Friday 2:00pm – 10:30pm ET (overtime eligible)
Equal opportunity, accessibility and legal noticesThermo Fisher Scientific's statements, word for word
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 39% below the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Senior & Principal roles in the US21 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $47,008 | — | $70,533 |
| All US (middle half) | $93,000 | $96,500 | $111,500 |
This role: Thermo Fisher Scientific's own published range, converted to a year at 2,080 hours. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 103 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 12 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership3
- GMP and compliance2
- Documentation and SOPs2
- Investigations and CAPA1
- Regulatory submissions1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 118
- Open roles
- 118
- Distinct roles
- 52
- Locations
By discipline
- Quality75 61%
- Clinical42 34%
- Regulatory6 5%
By level
- Senior & Principal57 46%
- Associate & Specialist35 28%
- Manager25 20%
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Sr. QA Technician - 2nd Shift at Thermo Fisher
Open until filled. $47K–$71K a year, employer provided.