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.
ISO 13485 in the job market
Last checked September 13, 2026
- Open roles
- 22
- Employers
- 8
- Median pay
- —
- Disclose pay
- —
on Career App right now
hiring for it
not enough disclosed
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
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 ↗
Asked for alongside ISO 13485
Measured from the 22 open roles that name ISO 13485 — not from a curated list.
- Root Cause Analysis6 roles27.3%
- Risk Management5 roles22.7%
- Failure Mode and Effects Analysis (FMEA)4 roles18.2%
- ISO 90014 roles18.2%
- Microsoft Excel4 roles18.2%
- Statistical Process Control (SPC)4 roles18.2%
- Corrective And Preventive Action (CAPA)3 roles13.6%
- Lean Six Sigma3 roles13.6%
Roles that use ISO 13485
Employers hiring for ISO 13485
8 in total, most open roles first.
- Beckman Coulter8 roles
- Gilead Sciences3 roles
- Medtronic3 roles
- AA-dec2 roles
- Biogen2 roles
- HHHims and Hers2 roles
Related skills
Curated neighbors in the taxonomy, whether or not employers ask for them together.