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Quality Engineer Medical Device Jobs in Oregon (NOW HIRING)

Quality Engineer

Portland, OR ยท On-site

$76K - $98K/yr

The Riverpoint Quality Engineer (QE) is responsible for driving proactive improvements to quality ... May collaborate with Regulatory on Medical Device Reporting (MDR) and adverse event reporting ...

Medical Device Assembler

Portland, OR ยท On-site

$18 - $20/hr

Come create your career with Volt Volt is immediately hiring a Medical Device Assembler in Portland ... Follow standard operating procedures (SOPs) to ensure compliance with FDA, GMP, and quality system ...

Quality Engineer

Oregon City, OR ยท On-site

$77K - $99K/yr

SHIFT No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer II supports ... Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS * Any Quality ...

Quality Engineer

Portland, OR ยท On-site

$76K - $98K/yr

SHIFT No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer II supports ... Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS * Any Quality ...

Quality Engineer

Tualatin, OR ยท On-site

$75K - $96K/yr

SHIFT No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer II supports ... Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS * Any Quality ...

Quality Engineer

West Linn, OR ยท On-site

$77K - $99K/yr

SHIFT No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer II supports ... Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS * Any Quality ...

Quality Engineer

Wilsonville, OR ยท On-site

$74K - $96K/yr

SHIFT No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer II supports ... Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS * Any Quality ...

Quality Engineer

Happy Valley, OR ยท On-site

$75K - $97K/yr

SHIFT No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer II supports ... Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS * Any Quality ...

Quality Engineer

Milwaukie, OR ยท On-site

$74K - $96K/yr

SHIFT No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer II supports ... Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS * Any Quality ...

Quality Engineer

Silverton, OR ยท On-site

$71K - $91K/yr

SHIFT No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer II supports ... Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS * Any Quality ...

Quality Engineer

Oregon City, OR ยท On-site

$77K - $99K/yr

SHIFT No Shift ($0) (United States of America) A BRIEF OVERVIEW The Quality Engineer II supports ... Experience in Medical Device Manufacturing (Preferred) LICENSES AND CERTIFICATIONS * Any Quality ...

OR ยท On-site

$89K - $123K/yr

... Solta Medical employees follow written SOPs and process specifications Participate in product ... A minimum of five years of Quality Engineering experience in a regulated industry. Strong drive to ...

Salary Minimum: 131,250 Salary Maximum: 270,250 Arthrex is a global medical device company and a ... We are actively seeking a Software QA Engineering Manager with strong critical thinking skills and ...

New

Quality Engineer 2

Hillsboro, OR ยท On-site

$78K - $101K/yr

Job Scope The NPI Quality Engineer II leads quality planning and ensures the quality of new ... Implantable medical device experience preferred. * Knowledge of FDA 21 CFR 820, ISO 13485, ISO ...

Quality Engineer 2

Hillsboro, OR

$78K - $101K/yr

Job Scope The NPI Quality Engineer II leads quality planning and ensures the quality of new ... Implantable medical device experience preferred. * Knowledge of FDA 21 CFR 820, ISO 13485, ISO ...

Senior Quality Engineer

Hillsboro, OR ยท On-site

$96K - $130K/yr

... Medical Device Directive, etc.). * Experience with CAPA and failure investigation tools and ... ASQ Certified Quality Engineer preferred. * Understanding of and experience with GD&T preferred.

Senior Quality Engineer

Hillsboro, OR

$96K - $130K/yr

... Medical Device Directive, etc.). * Experience with CAPA and failure investigation tools and ... ASQ Certified Quality Engineer preferred. * Understanding of and experience with GD&T preferred.

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Quality Engineer Medical Device information

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

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

What are the key skills and qualifications needed to thrive as a quality engineer in the medical device industry?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

How does a quality engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.
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 Quality Engineer Medical Device jobs in Oregon? For Quality Engineer Medical Device jobs in Oregon, the most frequently searched job titles are:
Infographic showing various Quality Engineer Medical Device job openings in Oregon as of July 2026, with employment types broken down into 82% Full Time, 11% Part Time, and 7% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Quality Engineer

RIVERPOINT MEDICAL LLC

Portland, OR โ€ข On-site

$76K - $98K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 24 days ago


Job description

Riverpoint Medical in Portland Oregon is looking to hire a Quality Engineer. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Riverpoint Quality Engineer (QE) is responsible for driving proactive improvements to quality systems and processes. The QE will work with production to support quality assurance, manage and resolve non-conformities, validate processes, resolve customer issues, and continually improve the quality system.

Duties and Responsibilities:

  • May provide oversight and ensure timely execution of the complaint handling process
  • May responsible for all complaint analysis activities and trending.
  • May collaborate with Regulatory on Medical Device Reporting (MDR) and adverse event reporting requirements
  • Coordinate planning, implementation and trending of multiple quality management systems including CAPA, SCAR, and non-conformances.
  • Perform internal and supplier audits
  • Assist in the writing and execution of system validation plans
  • Promote compliance to company procedures
  • Support process validation studies for special processes and drive a reduction in Riverpoint Medical’s reliance on inspection/verification as a quality assurance methodology
  • Develop and execute IQ, OQ and PQ protocols for product, processes, and equipment within the facility
  • Write reports summarizing results and statistics for all equipment, product, or process validation projects. Assist production with equipment installation and maintenance
  • Improve upon process controls related to Finished Device packaging, labelling and sterile product management, including aspects such as label reconciliation, segregation and material flow controls, and lot release activities
  • Participate in the timely processing of complaints, non-conformity, returned materials and corrective actions
  • Assist in investigations of incidents related to Riverpoint Medical products and appropriate reporting of such events to US and foreign regulatory authorities and notified bodies, as applicable
  • Assist in QA/RA, production and product development personnel in formatting and compiling quality system documents

Education and Qualifications

  • BS (engineering preferred) with 3+ years related experience in the medical device industry or MS engineering and 0+ years related experience, or equivalent experience
  • Complaint analysis activities and product failure investigations desirable
  • CAPA planning and implementation desirable
  • Use of Failure Mode Effects Analysis (FMEA) desirable
  • Work experience in an ISO13485 or FDA regulated environment desirable
  • Computer skills, including Word and Excel
  • Demonstrated technical writing skills


We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays.

Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.