# ISO 13485

Skill · Certifications and Credentials

Canonical page: https://career.thegoodapps.co/skills/iso-13485

ISO 13485 is an international standard specifying requirements for a quality management system dedicated to the design, development, production, and servicing of medical devices. Companies pursue certification to demonstrate regulatory compliance and consistent product safety and quality to regulators and customers. Quality assurance and regulatory affairs professionals in the medical device industry need familiarity with its requirements for audits and certification.

## ISO 13485 in the job market

- Open roles: 22
- Employers hiring: 8
- Last checked: September 14, 2026

## Asked for alongside ISO 13485

Measured from the 22 open roles that name ISO 13485, not from a curated list.

- [Root Cause Analysis](https://career.thegoodapps.co/skills/root-cause-analysis) — 6 roles (27.3%)
- [Risk Management](https://career.thegoodapps.co/skills/risk-management) — 5 roles (22.7%)
- [Failure Mode and Effects Analysis (FMEA)](https://career.thegoodapps.co/skills/failure-mode-and-effects-analysis-fmea) — 4 roles (18.2%)
- [ISO 9001](https://career.thegoodapps.co/skills/iso-9001) — 4 roles (18.2%)
- [Microsoft Excel](https://career.thegoodapps.co/skills/microsoft-excel) — 4 roles (18.2%)
- [Statistical Process Control (SPC)](https://career.thegoodapps.co/skills/statistical-process-control-spc) — 4 roles (18.2%)
- [Corrective And Preventive Action (CAPA)](https://career.thegoodapps.co/skills/corrective-and-preventive-action-capa) — 3 roles (13.6%)
- [Lean Six Sigma](https://career.thegoodapps.co/skills/lean-six-sigma) — 3 roles (13.6%)

## Roles that use ISO 13485

- [Quality Engineer](https://career.thegoodapps.co/occupations/quality-engineer) — 6
- [Manufacturing Engineer](https://career.thegoodapps.co/occupations/manufacturing-engineer) — 1
- [Manufacturing Manager](https://career.thegoodapps.co/occupations/manufacturing-manager) — 1
- [Process Engineer](https://career.thegoodapps.co/occupations/process-engineer) — 1
- [Product Owner](https://career.thegoodapps.co/occupations/product-owner) — 1
- [Project Manager](https://career.thegoodapps.co/occupations/project-manager) — 1

## Employers hiring for ISO 13485

- [Beckman Coulter](https://career.thegoodapps.co/organizations/beckman-coulter) — 8 open roles
- [Gilead Sciences](https://career.thegoodapps.co/organizations/gilead-sciences) — 3 open roles
- [Medtronic](https://career.thegoodapps.co/organizations/medtronic) — 3 open roles
- [A-dec](https://career.thegoodapps.co/organizations/a-dec) — 2 open roles
- [Biogen](https://career.thegoodapps.co/organizations/biogen) — 2 open roles
- [Hims and Hers](https://career.thegoodapps.co/organizations/hims-and-hers) — 2 open roles

Related skills: [Quality Management Systems](https://career.thegoodapps.co/skills/quality-management-systems)

## Open roles requiring ISO 13485 (21)

- [Sr. Process & Operations Engineer](https://career.thegoodapps.co/jobs/62de5956-c79d-486a-8e02-aad6e4eb15aa/sr-process-operations-engineer-at-hims-and-hers) at [Hims and Hers](https://career.thegoodapps.co/organizations/hims-and-hers) — Full-time, Minnetonka, MN, $130,000 – $150,000
- [Staff Quality Assurance Engineer](https://career.thegoodapps.co/jobs/6b391c8d-fe36-4459-8d6b-a4514d8b9d77/staff-quality-assurance-engineer-at-beckman-coulter) at [Beckman Coulter](https://career.thegoodapps.co/organizations/beckman-coulter) — Full-time, Indianapolis, IN
- [Head of Quality, Device and Combination Products](https://career.thegoodapps.co/jobs/c4e832a5-e510-4abb-ac8c-92da3f79b1e4/head-of-quality-device-and-combination-products-at-biogen) at [Biogen](https://career.thegoodapps.co/organizations/biogen) — Cambridge, MA
- [Manager, Quality Assurance](https://career.thegoodapps.co/jobs/57b2c78c-6d03-47ed-9163-83ef11b458ff/manager-quality-assurance-at-a-dec) at [A-dec](https://career.thegoodapps.co/organizations/a-dec) — Newberg, OR
- [Sr. Software Product Owner](https://career.thegoodapps.co/jobs/2abfcdf4-1bbe-4a20-88f4-6adea9e7d41a/sr-software-product-owner-at-medtronic) at [Medtronic](https://career.thegoodapps.co/organizations/medtronic) — Full-time, Boston, MA, $149,000 – $177,600
- [Director - Product Quality Complaints](https://career.thegoodapps.co/jobs/a54ffd1f-7d85-4b83-9648-e7cd97e21ac0/director-product-quality-complaints-at-gilead-sciences) at [Gilead Sciences](https://career.thegoodapps.co/organizations/gilead-sciences) — Full-time, United States - California - Foster City, $191,250 – $247,500
- [Director of Regulatory Affairs and Quality Assurance (RA / QA)](https://career.thegoodapps.co/jobs/4b81a714-4671-41d0-9f22-a783f32b6918/director-of-regulatory-affairs-and-quality-assurance-ra-qa-at-eight-sleep) at [Eight Sleep](https://career.thegoodapps.co/organizations/eight-sleep) — Full-time, San Francisco, CA
- [Sr. Product Development Engineer](https://career.thegoodapps.co/jobs/071f32d7-d002-494b-83f9-99748696ae4d/sr-product-development-engineer-at-hims-and-hers) at [Hims and Hers](https://career.thegoodapps.co/organizations/hims-and-hers) — Full-time, Minnetonka, MN, $130,000 – $150,000
- [Staff Quality Assurance-Supplier Quality Engineer](https://career.thegoodapps.co/jobs/1d6d3db3-165b-4c80-8cb0-dfd5eb0995e5/staff-quality-assurance-supplier-quality-engineer-at-beckman-coulter) at [Beckman Coulter](https://career.thegoodapps.co/organizations/beckman-coulter) — Full-time, Chaska, MN, $140,000 – $160,000
- [Principal Manufacturing Engineer - Implantable Device Unit](https://career.thegoodapps.co/jobs/8f4ec61b-64b7-42d1-9db0-7e6b40390583/principal-manufacturing-engineer-implantable-device-unit-at-biogen) at [Biogen](https://career.thegoodapps.co/organizations/biogen) — Full-time, Cambridge, MA, $159,000 – $219,000

All 21 open roles: https://career.thegoodapps.co/jobs?skills=4547ce98-7ad0-480d-bab6-482d4bfe7066