13485

Description Position at Prismatik We're looking for a Quality Assurance Engineer to help build quality into every stage of our medical device development and manufacturing. You'll have broad ownership across quality engineering, risk management, CAPA, validation, and our Quality Management System. Working closely with cross-functional teams, you'll...

Description Position at Prismatik We're looking for a Sr. QA Engineer to help build quality into every stage of our medical device development and manufacturing. You'll have broad ownership across quality engineering, risk management, CAPA, validation, and our Quality Management System. Working closely with cross-functional teams, you'll solve complex...

Job Description Job Description Description: Quality Manager | ISO 13485 Medical Device Manufacturing We are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader,...

Full-time Description Quality Manager | ISO 13485 Medical Device ManufacturingWe are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely...

Description: Quality Manager ISO 13485 Medical Device ManufacturingWe are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations,...

Description: Quality Manager | ISO 13485 Medical Device Manufacturing We are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations,...

Teledyne Technologies Incorporated seeks a Quality Systems and Compliance Manager to develop, implement, and continually improve the QMS in line with ISO 9001:2015, ISO 13485:2016, and MDR requirements. You will lead quality assurance, regulatory compliance, risk management, supplier quality, audits, CAPA, and post-market surveillance across cross-functional...

Job SummaryLead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams.Key ResponsibilitiesLead QMS, CAPA,...

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DescriptionNSF is seeking a certified Independent Contractor Medical Device ISO 13485 Lead Auditor with expertise in medical device sterilization processes to join our growing team. This remote opportunity offers flexibility, independence, and the chance to work with leading medical device manufacturers, sterilization providers, and suppliers across North...

The Quality Assessments Division of Smithers is seeking experienced ISO 13485 Third-Party Auditors to perform assessment and certification activities for medical device manufacturers and related organizations against ISO 13485 requirements and applicable regulatory standards. Your goal is to build positive relationships with our clients while providing...

Quality Engineer (Med Device/Healthcare/ISO 13485 EXP) About Us: SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience,...

Siemens Healthineers is seeking a Quality Control Inspector to ensure electromechanical components and sterile consumables meet regulatory and company standards. You will inspect PCBs, subassemblies, and finished products, generate NCMRs, and maintain GDP-compliant records. The role supports ISO 13485 QMS and continuous improvement in manufacturing...

About Viax Dental Technologies Viax Dental Technologies is a dental technology company developing FirstFit, a digital workflow and Software as a Medical Device (SaMD) for guided restorative dentistry. We are currently advancing our regulatory program toward FDA 510(k) clearance, EU MDR compliance/CE marking, and ISO 13485 certification. About the Role We are...

Description: Quality Manager | ISO 13485 Medical Device Manufacturing We are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations,...

Description: Quality Manager ISO 13485 Medical Device ManufacturingWe are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations,...

Seeking an experienced Medical Device Quality Manager to lead QMS, remediation, CAPA, audit readiness, and regulatory compliance programs. The role will work closely with cross-functional teams to ensure compliance with FDA, ISO 13485, and global medical device regulations.Must-Have Skills:12+ years of Medical Device Quality experience5+ years of Quality...

Job Summary: Support quality remediation and compliance initiatives by managing nonconformance, CAPA, deviation, complaint handling, and quality system activities. Perform quality assessments, root cause investigations, data analysis, and quality improvement initiatives while ensuring compliance with medical device regulations and standards Key...

The Quality Assessments Division of Smithers seeks full-time and contract auditors to join our team to assess our clients to management system standards including Quality, Environmental, Occupational Health and Safety, Automotive, Aerospace, and Information Security. If you want to be a part of our mission to provide our clients with accurate data, on-time...

Freudenberg Group is seeking a Site Quality Engineer to drive compliance and continuous improvement across medical device manufacturing. You will lead audits, CAPAs, and NPI quality activities, partnering with engineering, operations, and regulatory teams to ensure design transfer, process validation, and manufacturing quality.The role requires a...