Skip to main content
CareerApp

Skill

ISO 13485

Certifications and Credentials

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.

See who is hiring

ISO 13485 in the job market

Last checked September 13, 2026

Open roles
22

on Career App right now

Employers
8

hiring for it

Median pay

not enough disclosed

Disclose pay

of these roles

Open roles requiring ISO 13485 (22)

Sr. Process & Operations Engineer

Hims and Hers

Full-time · Minnetonka, MN · $130,000 – $150,000

This role oversees contract manufacturing operations for FDA-regulated medical devices, serving as the technical liaison between internal teams and external manufacturers. It suits experienced process engineers with deep medical device manufacturing expertise who can manage complex regulatory compliance and drive operational excellence across suppliers.

Listed on Hims and Hers’s careers site · Apply there ↗

Beckman Coulter

Staff Quality Assurance Engineer

Beckman Coulter

Full-time · Indianapolis, IN

This role leads quality assurance processes for medical device manufacturing at a major diagnostics company, managing compliance with regulatory standards and guiding teams through the quality lifecycle. It suits experienced quality engineers who want to influence manufacturing operations and drive process improvements in a regulated industry.

Listed on Beckman Coulter’s careers site · Apply there ↗

Biogen

Head of Quality, Device and Combination Products

Biogen

Cambridge, MA

Lead the quality strategy and global team for medical devices and combination products at a major biotech company, from design through lifecycle management. This role suits an experienced quality professional with deep regulatory knowledge and demonstrated leadership in device manufacturing compliance.

Listed on Biogen’s careers site · Apply there ↗

Manager, Quality Assurance

A-dec

Newberg, OR

This role leads a quality assurance team at a dental equipment manufacturer, overseeing compliance with regulatory standards and driving continuous improvement across the organization. It suits experienced quality professionals with a track record managing teams and implementing quality systems in regulated manufacturing environments.

Listed on A-dec’s careers site · Apply there ↗

Medtronic

Sr. Software Product Owner

Medtronic

Full-time · Boston, MA · $149,000 – $177,600

This role leads product strategy and development for a surgical robotics platform, managing stakeholder coordination and technical requirements across hardware-software systems in a heavily regulated medical device environment. It suits experienced product owners with deep expertise in embedded systems, regulatory compliance frameworks, and scaled agile methodologies who want to shape complex, safety-critical medical technology.

Listed on Medtronic’s careers site · Apply there ↗

Gilead Sciences

Director - Product Quality Complaints

Gilead Sciences

Full-time · United States - California - Foster City · $191,250 – $247,500

This director-level role oversees Gilead's global product quality complaints program, serving as the Global Process Owner for complaint handling across clinical and commercial products. It suits experienced quality leaders in pharma or medical devices who can drive regulatory compliance, process standardization, and cross-functional collaboration in a complex, highly regulated manufacturing environment.

Listed on Gilead Sciences’s careers site · Apply there ↗

Senior Manager, SQE

Agility Robotics

Full-time · Salem, OR · $146,000 – $189,000

Lead supplier quality and incoming material control for a robotics manufacturer, overseeing a team of engineers and technicians while managing global supplier qualifications, audits, and quality systems. This role suits an experienced quality leader with deep expertise in supplier management, advanced product quality planning, and manufacturing operations who can scale operations across complex hardware supply chains.

Listed on Agility Robotics’s careers site · Apply there ↗

Director of Regulatory Affairs and Quality Assurance (RA / QA)

Eight Sleep

Full-time · San Francisco, CA

Eight Sleep is hiring a Director of Regulatory Affairs and Quality Assurance to lead compliance, risk management, and FDA regulatory strategy for their medical-device sleep technology platform. This role suits experienced medical device professionals ready to shape regulatory practices at a growth-stage company with direct access to leadership and R&D.

Listed on Eight Sleep’s careers site · Apply there ↗

Sr. Product Development Engineer

Hims and Hers

Full-time · Minnetonka, MN · $130,000 – $150,000

This role designs and develops FDA-regulated medical devices and their packaging systems, from initial concept through manufacturing transfer. It suits experienced mechanical or biomedical engineers who are comfortable with regulatory compliance, design documentation, and cross-functional collaboration in a fast-moving healthcare setting.

Listed on Hims and Hers’s careers site · Apply there ↗

Beckman Coulter

Staff Quality Assurance-Supplier Quality Engineer

Beckman Coulter

Full-time · Chaska, MN · $140,000 – $160,000

This is a senior quality engineering role managing supplier transitions and cost-reduction design changes for medical diagnostic equipment at a life sciences company. It suits someone with 12+ years in quality engineering who wants to drive product improvements and supplier qualification in a regulated manufacturing environment.

Listed on Beckman Coulter’s careers site · Apply there ↗

View all 22 on Jobs

Asked for alongside ISO 13485

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

Employers hiring for ISO 13485

8 in total, most open roles first.

Related skills

Curated neighbors in the taxonomy, whether or not employers ask for them together.

Turn on analytics and we load Google Analytics: Google gets the pages you open and what you do here — searches, jobs you view, jobs you apply to — and sets its own cookies. Leave it off and the only cookies we set are your login, your theme, and this answer. Accept All also records a yes to advertising, which nothing uses yet. Privacy Policy.