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Remote Quality Engineer Medical Device Jobs in Oregon

A-dec, Inc.

Quality Assurance Specialist, Sr

Newberg, OR · Remote

$86K - $119K/yr

... Medical Device regulations and standards including US-FDA, Health Canada, and the European Union ... Fully remote is not an option due to manufacturing facility-based activities. Education and ...

Stryker

Senior Staff Medical Writer (Remote)

Portland, OR · On-site +1

$143K - $238K/yr

This position partners closely with Regulatory Affairs, Clinical Affairs, Quality, Research ... Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745 ...

Healthcare

Senior Software Quality Engineer

OR · On-site +1

Remote Travel: May include up to 20% domestic Relocation Assistance: May be authorized Must be ... In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision ...

Symbotic

Sr. Site Quality Engineer

OR · On-site +1

$88K - $119K/yr

Remote, field-based position based in the Northeast. * Approximately 75% of time will be spent ona ... The compensation package includes medical, dental, vision, disability, 401K, PTO and/or other ...

Aptyx

Business Development Executive

OR · On-site +1

This position is primarily focused on new customer acquisition within the medical device OEM and ... Partner closely with Engineering, R&D, Product Development, Operations, and Quality to define ...

AcuityMD

Enterprise Account Executive

OR · On-site +1

$200K - $300K/yr

You have 5+ years of experience selling Enterprise SaaS or Medical Device products * You should ... Remote work : AcuityMD is committed to supporting full-remote flexibility for employees in the US.

AcuityMD

Strategic Account Executive

OR · On-site +1

$250K - $360K/yr

You have 5+ years of experience selling Enterprise SaaS or Medical Device products * You should ... Remote work : AcuityMD is committed to supporting full-remote flexibility for employees in the US.

Bausch + Lomb

Product Cybersecurity Architect

OR · On-site +1

... in medical device, healthcare, or other regulated industries, and/or working within a quality ... US - Remote All qualified applicants will receive consideration for employment without regard to ...

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Remote Quality Engineer Medical Device information

What does a remote quality engineer in the medical device industry do?

A Remote Quality Engineer in the medical device industry is responsible for ensuring that medical products meet regulatory and quality standards while working from a remote location. Their duties often include reviewing and improving quality processes, conducting audits, analyzing data to identify trends or issues, and ensuring compliance with regulations such as FDA or ISO 13485. They collaborate with cross-functional teams to resolve quality issues and may also be involved in risk management and validation activities. Remote Quality Engineers use digital tools to communicate and manage documentation, making it possible to fulfill their role away from a traditional office or manufacturing environment.

How does a remote quality engineer in the medical device industry effectively collaborate with cross-functional teams despite working off-site?

Remote Quality Engineers in the medical device sector regularly use digital collaboration tools such as video conferencing, shared documentation platforms, and cloud-based quality management systems to stay connected with design, manufacturing, and regulatory teams. While working remotely poses challenges in terms of immediate access to physical devices and face-to-face communication, frequent virtual meetings and clear documentation help ensure alignment on project goals and compliance requirements. Building strong relationships with on-site team members and proactively seeking feedback are key strategies for maintaining effective collaboration and ensuring product quality.

What are the key skills and qualifications needed to thrive as a remote quality engineer in medical devices, and why are they important?

To thrive as a Remote Quality Engineer in Medical Devices, you need a solid background in quality assurance, regulatory compliance (such as FDA and ISO 13485), and engineering principles, typically supported by a relevant engineering degree. Proficiency with quality management systems (QMS), document control software, and risk assessment tools is common, and certifications like ASQ CQE are highly valued. Strong attention to detail, effective problem-solving, and clear remote communication skills help ensure compliance and collaboration across distributed teams. These abilities are crucial for maintaining product safety, meeting regulatory standards, and driving continuous improvement in a regulated industry.

What are the most commonly searched types of Quality Engineer Medical Device jobs in Oregon?

The most popular types of Quality Engineer Medical Device jobs in Oregon are:

What are popular job titles related to Remote Quality Engineer Medical Device jobs in Oregon?

For Remote Quality Engineer Medical Device jobs in Oregon, the most frequently searched job titles are:

What job categories do people searching Remote Quality Engineer Medical Device jobs in Oregon look for?

The top searched job categories for Remote Quality Engineer Medical Device jobs in Oregon are:

What cities in Oregon are hiring for Remote Quality Engineer Medical Device jobs?

Cities in Oregon with the most Remote Quality Engineer Medical Device job openings:

Remote Quality Engineer Medical Device jobs near you
Infographic showing various Remote Quality Engineer Medical Device job openings in Oregon as of August 2026, with employment types broken down into 72% Full Time, and 28% Contract. Highlights an 100% Remote job distribution.

Associate Director, Device Engineering

OR • On-site, Remote

Kailera Therapeutics, Inc.
See more jobs at Kailera Therapeutics, Inc.external

Full-time

Posted 26 days ago

Key responsibilities

  • Lead combination product development projects from concept through commercialization.

  • Build and execute project plans with risks and milestones, and oversee design verification and validation activities.

  • Partner cross-functionally with various teams to ensure device development aligns with standards, regulations, and stakeholder needs.

Job description

What You'll Do:

We are seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens. This role will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development aligned with meeting patient needs, global standards, and regulatory expectations.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities:

  • Lead combination product development projects (prefilled syringes, autoinjectors, and/or multidose pens) from concept through commercialization
  • Build and execute project plans with clearly defined risks and milestones
  • Develop device and combination product requirements, including user and stakeholder needs and technical requirements, and ensure appropriate engineering translation and subsequent verification and validation of requirements
  • Oversee and ensure compliance with design controls per FDA and ISO 13485 requirements
  • Manage risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and risk mitigation strategies
  • Drive design verification and validation activities, including test method development, protocol execution, and documentation
  • Oversee human factors and usability engineering efforts, ensuring compliance with FDA guidance and IEC 62366
  • Facilitate design transfer to manufacturing, ensuring smooth transition and scalability
  • Partner cross-functionally with CMC, quality, regulatory, clinical development, commercial/marketing, supply chain, and other key functions to ensure critical inputs are integrated into device development activities
  • Author relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for devices and combination product programs
  • Manage and collaborate with vendors, including Contract Design and Manufacturing Organizations (CDMOs) and suppliers, to ensure components and products meet quality and technical requirements and to integrate deliverables into the project Design History File at various stages of development and manufacturing
  • Manage and collaborate with contract test labs to ensure testing strategy, method validation, and test execution are aligned with relevant standards and quality and technical requirements and integrate testing results into the Design History File
  • Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, IEC 62366

Required Qualifications:

  • Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role
  • Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions
  • Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer
  • Strong knowledge of applicable regulatory standards and guidance documents
  • Excellent communication, leadership, and cross-functional collaboration skills

 

Preferred Qualifications:

  • Experience working in a regulated pharmaceutical or biotech environment
  • Familiarity with combination product regulations (21 CFR Part 4)
  • Experience with supplier management of external development, testing, and manufacturing partners
  • PMP certification or formal project management training is a plus

Education:

  • Bachelor's degree in mechanical engineering, Biomedical Engineering, or related field. Advanced degree preferred.

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