Sr. Product Quality Engineer (ISO 13485 / PRRC)

The purpose for this position is to provide quality control for the manufacturing process and the ISO 13485 champion role in Portland.

The Product Quality Engineer works closely with marketing/ product management / development / manufacturing / quality management and regulatory within Clario business lines to establish/ensure compliance of Clario’s products and assets are compliant with Clario’s quality system and applicable regulations. The Product Quality Engineer is responsible for all tasks related to Technical Files/Documentation and for following established GMP/GCP/ISO compliant quality system practices.

Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what’s possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence. 

What we offer: 

• Competitive compensation 

• Medical, dental, and vision insurance beginning Day 1 of employment 

• Flexible work schedules 

• Attractive PTO plan 

• Engaging employee programs 

• Hybrid Role - The role will start out in the office with the ability to work hybrid in the future

What you'll be doing:

The Senior Product Quality Engineer works closely with marketing/ product management / development / manufacturing / quality management and regulatory within Clario business lines to establish/ensure compliance of Clario’s products and assets are compliant with Clario’s quality system and applicable regulations.

The Senior Product Quality Engineer is responsible for all tasks related to Technical Files/Documentation and for following established GMP/GCP/ISO compliant quality system practices.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ensure Product and Process compliance according to Medical Device and applicable non-Medical Device Regulations (e.g. FDA, EU MDR, HC MDR, RED, FCC) and ICH guidelines in regard to CAPA/Complaint Management, Production & Supply Chain and Clinical Trial Services.
• Supports Design Assurance Engineer/Product Quality Engineer to ensure compliance and implementation of Clario’s design control processes (e.g. PDLC, PLC, DLC, SDLC) in assigned projects
• Reviews Development and Technical Documentation during Design Projects related to manufacturing; consideration of current standards and regulations for Transfer to Manufacture; implementing T2M to ensure that design and development outputs have been completed prior to becoming a final product.
• Participate in Risk Management throughout the medical device life cycle, incl. production and post release.
• Contribution to review of product and asset information, labelling and/or marketing material
• Supervision and direction of quality assurance activities in receiving inspection, production, and process control and final inspection, incl. decision upon quality related measures before shipment of products and control execution of corrective measures.
• Organization and definition of all necessary inspections and testing techniques for the products in relationship with change management, complaint issues, final inspection and production engineering.
• Perform quality checks on design control, production and study related documentation.
• Support Validation activities to ensure fulfils intended and ‘indications for use’ requirements.
• Support Clinical Trial Verification and Validation activities and resolve open issues.
• Support Usability activities to demonstrate fit for purpose and is supporting client needs Support of the Regulatory Affairs designee, e.g. assist with international regulatory product registrations.
• Support the revision of procedures, policies and work instructions to ensure compliance with local and international regulations. Decide on Deviations and Non-Conformity Activities.
• Compile change management, CAPA and complaint related KPIs including statistical analysis and periodic reports.
• Participate in the data analysis for post market surveillance activities.
• Provide regulatory expertise to assigned projects throughout the life cycle Perform and support any project specific internal and external audit activities to ensure Compliance with Clario’s QMS.
• Provide Training to departme