Product Quality Engineer
1 week ago
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.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 projectsReviews 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 postrelease.Contribution to review of product and asset information, labelling and/or marketing materialSupervision 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 departments on quality regulations and quality processes.OTHER DUTIES AND RESPONSIBILITIES:Contributes to team effort byExploring new opportunities to add value to organization and departmental processesSupport other departments in processing change requests, CAPA and complaints.Maintain the status of documents in design projects.Support article introduction during development projects.Communicate status of Changes, CAPAs and Complaints to other departments.Adapt Quality Processes to changes in R&D and Production Processes if necessary.Knowledge of all quality core processesMaintains Professional and Technical Knowledge byAttending and participating in applicable company sponsored trainingAttending educational workshops and reviewing professional publicationsBenchmarking state-of-the-art practicesParticipating in professional societiesKeeping informed of changes in the regulatory environment and/or regulatory requirementsQUALIFICATIONS AND SKILLS NEEDED:Education:Technical Education (Bachelor degree or equivalent) required in computer sciences, Health/Life Sciences, or equivalent and relevant work experience in a product development environment.Experience:Preferred at least 3 years of experience with Design Controls (e.g. Computer System Validation) and Quality Management systems (21 CFR Part 820, ISO 9001, ISO 13485) in a regulated environmentPreferred at least 2 years of working in cGMP and/or GCP regulated environmentsPreferred working experience of ISO and/or GCP related risk management activities and risk mitigation strategiesBasic auditor experience in a GCP/GMP environment is a plusGood troubleshooting and communication skillsGood command of English. Additional language skills preferred.Experience managing CAPAs and complaints.Excellent skills in analyzing issues and processes.Team oriented with excellent communication and organizational skills.Strong interpersonal and communication skills, both verbal and writtenGoal orientedDetail orientedAbility to make sound judgmentsSuperior problem-solving skillsAbility to manage multiple tasks effectively & efficientlyThe duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.
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Product Quality Engineer
7 days ago
Portland, Oregon, United States Clario Tech Full timeThe 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...
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Product Quality Engineer
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Portland, United States Powin Corporation Full timeWe're Building the Future! Ever want to do hard work that will make a REAL difference in the world? Do you want to solve some of the most difficult problems with a team of exceptional players at a company that does not believe in impossible?About Powin: Powin Energy is a leading producer of utility scale modular battery energy storage system (complete with a...
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Portland, United States Verify Full timeOverview: Industry: Aerospace/Defense Position: Quality Engineer Location: Portland, OR Frequency 35 Hours per week - W2 Duration: On-Going Pay Range:$38.00-$45.00 Job Description: Utilize quality science techniques to effect continuous performance improvement at assigned suppliers Reviews, analyzes, and reports on quality discrepancies related to process,...
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Quality Engineer
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Portland, Oregon, United States Verify Full timeOverview: Industry: Aerospace/Defense Position: Quality Engineer Location: Portland, OR Frequency 35 Hours per week - W2 Duration: On-Going Pay Range:$38.00-$45.00 Job Description: Utilize quality science techniques to effect continuous performance improvement at assigned suppliers Reviews, analyzes, and reports on quality discrepancies related to process,...
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Aerospace Quality Engineer
4 weeks ago
Portland, United States Trigo ADR Americas Full timeJob DescriptionJob DescriptionThe Quality Engineer will evaluate and/or appraise supplier's manufacturing capabilities to baseline their processes for conformance to various documented commodity checklists, and/or QMS special processes. Establishes part quality evaluation plans from materials requests through material receipt (full life-cycle). Provides...
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Aerospace Quality Engineer
2 weeks ago
Portland, United States Trigo ADR Americas Full timeThe Quality Engineer will evaluate and/or appraise supplier's manufacturing capabilities to baseline their processes for conformance to various documented commodity checklists, and/or QMS special processes. Establishes part quality evaluation plans from materials requests through material receipt (full life-cycle). Provides resolution and disposition of...
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Aerospace Quality Engineer
3 weeks ago
Portland, United States Trigo ADR Americas Full timeThe Quality Engineer will evaluate and/or appraise supplier's manufacturing capabilities to baseline their processes for conformance to various documented commodity checklists, and/or QMS special processes. Establishes part quality evaluation plans from materials requests through material receipt (full life-cycle). Provides resolution and disposition of...
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Aerospace Quality Engineer
1 month ago
Portland, United States Trigo ADR Americas Full timeThe Quality Engineer will evaluate and/or appraise supplier's manufacturing capabilities to baseline their processes for conformance to various documented commodity checklists, and/or QMS special processes. Establishes part quality evaluation plans from materials requests through material receipt (full life-cycle). Provides resolution and disposition of...
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Product Engineer III
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Senior Design Quality Engineer
1 month ago
Portland, United States Riverpoint Medical Full timeJob Description Job Description Riverpoint Medical in Northeast Portland is hiring a Sr Design 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,...
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Portland, United States Celestica Full timeSummary The Supplier Quality Engineer drives customer focus excellence and continuous improvement throughout our external and vertically integrated suppliers and ensures compliance with Industry, Customer and Celestica Requirements. We drive a Zero Defect culture with emphasis on maximizing value and preventing quality problems. Quantifying, managing and...
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Senior Design Quality Engineer
2 months ago
Portland, United States Riverpoint Medical Full timeJob DescriptionJob DescriptionRiverpoint Medical in Northeast Portland is hiring a Sr Design 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,...
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1 month ago
Portland, United States Covetrus Full timeThe Supplier Quality Engineer is responsible for establishing and leading a robust supplier quality management program tailored to serve multiple lines of business across North America 503A compounding pharmacies, 503B outsourcing facilities, commercial pharmacies, and distribution centers. The ideal candidate understands the importance of streamlined...
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Supplier Quality Engineer
3 weeks ago
Portland, United States Covetrus Full timeThe Supplier Quality Engineer is responsible for establishing and leading a robust supplier quality management program tailored to serve multiple lines of business across North America 503A compounding pharmacies, 503B outsourcing facilities, commercial pharmacies, and distribution centers. The ideal candidate understands the importance of streamlined...
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Supplier Quality Engineer
6 days ago
Portland, United States Celestica Full timeSummary The Supplier Quality Engineer drives customer focus excellence and continuous improvement throughout our external and vertically integrated suppliers and ensures compliance with Industry, Customer and Celestica Requirements. We drive a Zero Defect culture with emphasis on maximizing value and preventing quality problems. Quantifying, managing and...
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Supplier Quality Engineer
1 month ago
Portland, United States Celestica Full timeSummaryThe Supplier Quality Engineer drives customer focus excellence and continuous improvement throughout our external and vertically integrated suppliers and ensures compliance with Industry, Customer and Celestica Requirements. We drive a Zero Defect culture with emphasis on maximizing value and preventing quality problems. Quantifying, managing and...
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Supplier Quality Engineer
1 month ago
Portland, United States Celestica Full timeSummaryThe Supplier Quality Engineer drives customer focus excellence and continuous improvement throughout our external and vertically integrated suppliers and ensures compliance with Industry, Customer and Celestica Requirements. We drive a Zero Defect culture with emphasis on maximizing value and preventing quality problems. Quantifying, managing and...
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Supplier Quality Engineer
3 weeks ago
Portland, United States Celestica Full timeSummaryThe Supplier Quality Engineer drives customer focus excellence and continuous improvement throughout our external and vertically integrated suppliers and ensures compliance with Industry, Customer and Celestica Requirements. We drive a Zero Defect culture with emphasis on maximizing value and preventing quality problems. Quantifying, managing and...
