Senior Quality Assurance Engineer

1 week ago

Portland, Oregon, United States Clario, Inc. Full time
Job Title: Senior Product Quality Engineer

Clario, Inc. is seeking a highly skilled Senior Product Quality Engineer to join our team. As a key member of our quality management team, you will be responsible for ensuring the compliance of our products and assets with our quality system and applicable regulations.

Key Responsibilities:
  • Ensure product and process compliance with medical device and non-medical device regulations, including FDA, EU MDR, and ICH guidelines.
  • Support design assurance engineers to ensure compliance and implementation of Clario's design control processes.
  • Review development and technical documentation during design projects, considering current standards and regulations for transfer to manufacture.
  • Participate in risk management throughout the medical device life cycle, including production and post-release.
  • Contribute to the review of product and asset information, labeling, and marketing materials.
  • Supervise and direct quality assurance activities, including receiving inspection, production, and process control, and final inspection.
  • Perform quality checks on design control, production, and study-related documentation.
  • Support validation activities to ensure compliance with intended and 'indications for use' requirements.
  • Support clinical trial verification and validation activities and resolve open issues.
  • Assist with international regulatory product registrations and support the revision of procedures, policies, and work instructions.
  • Compile change management, CAPA, and complaint-related KPIs, including statistical analysis and periodic reports.
  • Participate in data analysis for post-market surveillance activities.
Requirements:
  • Technical education (bachelor's degree or equivalent) in computer sciences, health/life sciences, or equivalent, and relevant work experience in a product development environment.
  • At least 5 years of experience in quality management and/or regulatory affairs in a (EU) MDR (Medical Device) regulated environment.
  • Preferred experience with design controls, quality assurance activities, and quality management systems in a regulated environment.
  • Good troubleshooting and communication skills, with a good command of English and additional language skills preferred.
  • Experience managing CAPAs and complaints, with excellent skills in analyzing issues and processes.
  • Team-oriented with excellent communication and organizational skills, strong interpersonal and communication skills, both verbal and written.
About Clario, Inc.

Clario, Inc. is a 50+ year old company that delivers industry-leading clinical trial endpoint technology solutions. We are committed to providing innovative solutions that unlock better evidence in clinical trials.

We offer a competitive compensation package, medical, dental, and vision insurance, flexible work schedules, attractive PTO plans, engaging employee programs, and a hybrid work environment.

Clario, Inc. is an equal opportunity employer and evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

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