MES Quality Engineer II
1 week ago
The MES Quality Engineer II position plays a critical role in ensuring the successful implementation of Manufacturing Execution Systems (MES) projects at Terumo Medical Corporation. This role will work closely with cross-functional teams to ensure compliance and timely delivery of projects related to MES.
Key Responsibilities- Act as an integrated MES team member to support new MES deployments, sustaining, and optimization projects
- Develop and/or revise MES requirements documentation, procedures, control plans, PFMEAs, and training materials
- Maintain the compliance of the MES, the integrity of its validated state, and the eDHR
- Proactively identifies requirements gaps, investigates, and implements best-in-class Quality Engineering practices and solutions
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to MES
- Develop MES validation test cases and support Software Verification & Validation activities
- Support the Elkton, MD site as a subject matter expert (SME) related to MES and the integration with Product Life Cycle Management
- Develop training strategy plans and support MES team to deliver training on MES processes
- Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC
- Excellent communication skills; verbal and written
- Ability to work as a team member on cross-functional teams and with employees across all levels within the facility
- Excellent computer skills and working knowledge of Microsoft Office Suite
- Problem-solving and critical thinking
- Detail and results-oriented
- Self-motivated and driven
- Ability to multitask, prioritize, and provide deliverables within the required timeframe
- Excellent organizational and time management skills
- Requires Bachelor's degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science or technical field with relevant experience
- Requires at least three (3) years experiences in a medical device or highly regulated industry
- Experience working in a manufacturing environment preferred
- Experience with implementing and maintaining a Manufacturing Execution System / eDHR preferred
- Experience with Change Management, Computer System Validation, and HP ALM preferred
Terumo is an equal opportunity employer and welcomes applications from diverse candidates.
-
Quality Assurance Engineer
2 weeks ago
Elkton, Minnesota, United States Manpower Group Inc. Full timeJob Title: Quality Engineer IIWe are seeking a highly skilled Quality Engineer II to join our team at Manpower Group Inc. in Elkton, MD. As a Quality Engineer II, you will play a critical role in ensuring that our medical devices meet or exceed customer expectations and requirements.Key Responsibilities:Investigate and implement best-in-class Quality...
-
Quality Assurance Specialist
6 hours ago
Elkton, Minnesota, United States Terumo Full timeJob SummaryThe Quality Engineer II position plays a crucial role in ensuring that goods meet or exceed customer expectations and requirements. This role will work closely with the Operations and Engineering Team to drive continuous improvement and support production and project activities.Key ResponsibilitiesInvestigate and implement best-in-class Quality...
-
Quality Assurance Specialist
1 week ago
Elkton, Minnesota, United States Terumo Full timeJob SummaryThe Quality Engineer II position plays a crucial role in ensuring that goods meet or exceed customer expectations and requirements. This role will work closely with the Operations and Engineering Team to drive continuous improvement and support production and project activities.Key ResponsibilitiesInvestigate and implement best-in-class Quality...
-
Quality Assurance Specialist
2 weeks ago
Elkton, Minnesota, United States Terumo Medical Corporation Full timeJob SummaryThe Quality Engineer II position plays a crucial role in ensuring that goods meet or exceed customer expectations and requirements. This role will work closely with the Operations and Engineering Team to drive continuous improvement, ensure compliance to Terumo's quality policy, and respond to customer complaints.Key ResponsibilitiesProactively...
-
Senior Quality Systems Engineer
2 weeks ago
Elkton, Minnesota, United States Terumo Full timeJob Title: Senior Quality Systems EngineerTerumo Medical Corporation is seeking a highly skilled Senior Quality Systems Engineer to drive our efforts in ensuring compliance with global Quality System regulations. As a key member of our team, you will play a critical role in maintaining our Quality Management System and ensuring the effectiveness of our...
-
Senior Quality Systems Engineer
2 weeks ago
Elkton, Minnesota, United States Terumo Medical Corporation Full timeJob Title: Senior Quality Systems EngineerTerumo Medical Corporation is seeking a highly skilled Senior Quality Systems Engineer to join our team. As a key member of our Quality Systems department, you will be responsible for ensuring compliance with global Quality System regulations and driving our efforts to maintain a robust and effective Quality...
-
Senior Quality Systems Engineer
1 day ago
Elkton, Minnesota, United States Terumo Full timeJob Title: Senior Quality Systems EngineerJob Summary:The Senior Quality Systems Engineer will drive Terumo's efforts to ensure compliance with applicable global Quality System regulations in an efficient manner.Key Responsibilities:Support the management and effectiveness of the Quality Management System, primarily the CAPA systemProvide guidance to CAPA...
-
Senior Quality Systems Engineer
6 days ago
Elkton, Minnesota, United States Terumo Medical Corporation Full timeJob Summary:The Senior Quality Systems Engineer will drive Terumo Medical Corporation's efforts to ensure compliance with global quality system regulations in an efficient manner.Key Responsibilities:Support the management and effectiveness of the Quality Management System, primarily the CAPA systemProvide guidance to CAPA Teams and participate on CAPA Teams...
-
Senior Quality Systems Engineer
1 day ago
Elkton, Minnesota, United States Terumo Full timeJob Summary:The Senior Quality Systems Engineer will play a key role in ensuring compliance with global quality system regulations, including 21 CFR Part 820 and ISO 13485:2016. This individual will drive the implementation of effective quality management systems, focusing on the CAPA process.Key Responsibilities:Provide guidance and support to CAPA...
-
Process Engineer
18 hours ago
Elkton, Minnesota, United States Terumo Medical Corporation Full timeJob SummaryThe Engineer II Process Engineering position is a mid-level engineering role responsible for providing engineering support to existing product process transfer projects, process improvements/cost reduction activities affecting the form, fit or function of the product, and new product development process and production equipment development...
-
Process Engineer
1 day ago
Elkton, Minnesota, United States Terumo Medical Corporation Full timeJob SummaryThe Engineer II Process Engineering position is a mid-level engineering role responsible for providing engineering support to existing product process transfer projects, process improvements/cost reduction activities affecting the form, fit or function of the product, and new product development process and production equipment development...
-
Quality Assurance Specialist
2 weeks ago
Elkton, Minnesota, United States Innova Solutions Full timeJob Description:The Quality Specialist will play a crucial role in supporting manufacturing operations by becoming familiar with site processes, procedures, and policies. This individual will develop knowledge aligned with cGMPs and Health Authority regulations, ensuring compliance and quality standards are met.Key Responsibilities:Support the review and...
-
Global Automation Specialist
2 weeks ago
Elkton, Minnesota, United States Michael Page Full timeJob Title: Global Automation EngineerMichael Page is seeking a highly skilled Global Automation Engineer to join their team. As a key member of the global virtual team, you will play a crucial role in standardizing and digitalizing processes across the company's sites.About the RoleThis exciting opportunity offers a challenging and rewarding experience in...
-
Ultrasound Technologist II Position
1 day ago
Elkton, Minnesota, United States Christiana Care Full timeJob SummaryWe are seeking a highly skilled and experienced Ultrasound Technologist II to join our team at Christiana Care's Union Hospital. The successful candidate will be responsible for performing diagnostic ultrasound procedures, including noninvasive peripheral vascular testing, to aid in the diagnosis of disease or related abnormalities.Key...
-
Mission Assurance Engineer
17 hours ago
Elkton, Minnesota, United States Northrop Grumman Full timeJob Title: Mission Assurance EngineerWe are seeking a highly skilled Mission Assurance Engineer to join our team at Northrop Grumman. As a Mission Assurance Engineer, you will be responsible for ensuring the quality and reliability of our products and services.Key Responsibilities:Develop and implement quality assurance plans and procedures to ensure...
-
Senior Manufacturing Engineer
2 weeks ago
Elkton, Minnesota, United States Terumo Full timeJob SummaryThe Senior Engineer 1 - Manufacturing Engineer position is responsible for ensuring the successful day-to-day operation and continuous improvement of a dedicated endovascular medical device manufacturing process within the Terumo Medical Corporation (TMC) Elkton, MD facility.Key ResponsibilitiesProvide manufacturing engineering expertise in the...
-
Senior Manufacturing Engineer
1 day ago
Elkton, Minnesota, United States Terumo Full timeAbout TerumoTerumo Medical Corporation is a leading global medical device manufacturer, dedicated to providing innovative solutions for the healthcare industry. With a strong commitment to quality and customer satisfaction, we strive to make a positive impact on patients' lives.Job SummaryThe Senior Engineer - Manufacturing Engineer position is a key role...
-
Welding Engineer
3 weeks ago
Elkton, Minnesota, United States Autokiniton Full timeJob Title: Welding EngineerAt Autokiniton, we are seeking a skilled Welding Engineer to join our team. As a key member of our production team, you will be responsible for ensuring the quality and efficiency of our welding processes.Key Responsibilities:Maintenance floor support on all welding equipment, including programming, weld integrity, cut and etch...
-
Elkton, Minnesota, United States Terumo Medical Corporation Full timeJob SummaryThe Director of Quality Systems and Compliance is responsible for the design, development, deployment, and maintenance of the company's Quality System. This individual serves as the primary interface with external regulatory agencies for audits and ensures the Quality System is continually compliant with all applicable regulations and...
-
Senior Process Engineer
2 days ago
Elkton, Minnesota, United States Terumo Full timeJob SummaryThe Sr. Engineer I - Process Engineering position is responsible for providing advanced engineering support to existing product process transfer projects, process improvements/cost reduction activities affecting the form, fit or function of the product, and new product development process and production equipment development requirements in...