New · posted Nov 12
Katecho · Medical Devices
Quality Systems Administrator
- Des Moines, IA
- On-site
- Full-time
- Associate & Specialist
The role
Works as an effective member of the team to complete the daily functions in the Department. Assist in completing administrative work for the department.
Description
AUTHORITY
- Trains lower-level employees in the Lead’s respective area.
- Rejects non-conforming product.
- Assigns employees to jobs in the respective area.
- Interfaces with other departments to ensure all quality rejects and/or problems are brought to the attention of responsible personnel.
- Works on continuously improving the organization and function of the Department by suggesting procedural improvements.
What you need
- Minimum of one of year Administrative Admin experience.
- Proficient in computer applications including Word, Excel, Outlook, PowerPoint, etc.
- Strong communication skills.
- Detail oriented and accurate.
- Professional demeanor with strong interpersonal skills.
- Discreet and able to maintain confidentiality of information.
- Flexible and able to prioritize multiple tasks in a fast-paced environment and complete them in a timely manner.
- Must be able to work independently, as well as part of a team.
- Good work attendance and dependability.
- Able to read and write English, bilingual a plus.
- Must be able to pass a criminal background check.
What you'll do
- Assists in producing necessary paperwork in an accurate and timely manner. Works with other departments to resolve any outstanding issues.
- Tracks, updates, and completes data entry as required. Processes reports and maintain database systems.
- Assists in the preparation and control of centralized documents and records for the Company in accordance with ISO13485 and FDA Title 21 Part 210 & 211 & 820 (QSR) within IQMS. Tracks document revisions and distributions according to applicable procedures and instructions.
- Provides administrative support to the department as necessary or directed. (Copies, typing, data entry, filing, etc.).
- Maintains confidentiality of all information
- Works with the manager on continually improving the department and functionality by streamlining existing processes and implementing new processes.
- Regular and reliable attendance is an essential function of this job. Punctuality and regular attendance are crucial for efficient plant operations, safety, and morale.
- Other job responsibilities will be added as required at the direction of the department manager.
Where you'll work
Des Moines, IAOn-siteOpen in Maps (opens in a new tab)
More jobs in Des Moines, IAJob intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US22 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $81,625 | $94,750 | $110,125 |
Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 97 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Katecho's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership4
- Documentation and SOPs2
- Investigations and CAPA1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in medical devices, led by the two 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 devicesNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- 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
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- 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
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- 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
Katecho on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 1
- Locations
By discipline
- Quality7 100%
By level
- Senior & Principal3 43%
- Associate & Specialist3 43%
- Manager1 14%
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Quality Systems Administrator at Katecho
Open until filled.