Quality Systems Engineer
hace 1 mes
At Nextern, we are seeking a highly skilled Quality Systems Engineer to join our team. As a key member of our organization, you will be responsible for maintaining and implementing process improvements to our Global Quality System (QMS) procedures.
Key Responsibilities:- Lead and facilitate global QMS procedure changes and process improvements to align business processes or changes to industry standards and requirements.
- Support configuration activities of Agile PLM to support new or improved processes.
- Utilize project management, Six Sigma, Lean, or other disciplines to improve Quality System processes.
- Support stakeholders with software validation efforts.
- Support on-boarding of new employees with Quality System processes and Agile PLM setup.
- Prepare and analyze Quality System metrics for presentation to stakeholders and top management.
- Support internal, external, and third-party audits.
- Bachelor's Degree in Engineering or relevant area, plus 2-5 years of relevant experience in ISO 13485 and FDA GMP.
- Experience with Quality System process improvement, including project management, document management, data analysis, and presenting to cross-functional teams and leadership.
- Fully bilingual Spanish-English.
- Excellent skills in standard computer-based software programs such as Microsoft Office.
- Excellent learning agility.
- Ability to effectively build and maintain relationships, communicate, and interact with a variety of personalities.
- Experience with database administration/configuration.
- Agile PLM, Microsoft Power BI, Epicor (ERP) experience or other similar applications.
- Project management experience.
- Training/certification in Lean and Six Sigma.
- Training/certification in lead auditing ISO 13485 and FDA GMP systems.
Competitive compensation package.
-
Quality Systems Engineer
hace 4 semanas
Paraíso, Paraíso, Costa Rica Boston Scientific Corporation A tiempo completoAbout the Role:This is an exciting opportunity to join Boston Scientific Corporation as a Quality Systems Engineer. As a key member of our team, you will be responsible for establishing, developing, and maintaining procedures related to different elements of the Quality Management system to meet regulatory requirements, corporate policies, internal policies,...
-
Quality Systems Engineer II
hace 4 semanas
Paraíso, Paraíso, Costa Rica Boston Scientific Corporation A tiempo completoAbout the Role:At Boston Scientific Corporation, we are seeking a highly skilled Quality Systems Engineer II to join our team in Cartago, Costa Rica. This is an exciting opportunity to be part of a green field start-up operation and contribute to the development of a new team and culture.Key Responsibilities:Provide Quality Engineering and Quality Process...
-
Principal Quality Systems Engineer
hace 2 semanas
Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completoJob DescriptionWe are seeking a highly skilled Principal Quality Systems Engineer to join our team at Edwards Lifesciences.About the Role:This is a full-time position responsible for ensuring compliance of the QMS and compliance within quality processes (e.g., CAPA, NCR, ECR, internal and external auditing, training).The selected candidate will be...
-
Quality Systems Engineer II Leader
hace 6 días
Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completoAt Boston Scientific, we're a global leader in medical science with over 40 years of experience solving challenges that matter most. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives and create value for our customers.We're seeking a highly skilled Quality Systems Engineer II...
-
Senior Quality Systems Engineer
hace 6 días
Paraíso, Paraíso, Costa Rica Boston Scientific Corporation A tiempo completoAbout the Role: We are seeking a highly motivated Sr Quality Systems Engineer to join our team in Cartago, Costa Rica. As one of the first employees at this new site, you will play a key role in establishing and developing quality processes that meet regulatory requirements, corporate policies, and business needs.
-
Quality Systems Engineer
hace 3 semanas
Paraíso, Paraíso, Costa Rica Nextern A tiempo completoThe Global Quality System Process Specialist will be responsible for maintaining and implementing process improvements to Nextern's Quality System procedures, including software configuration and supporting internal audits. This position requires experience with Agile PLM, data analysis, and presentation to cross-functional teams and leadership.Duties and...
-
Senior Quality Assurance Automation Engineer
hace 4 semanas
Paraíso, Paraíso, Costa Rica Torre A tiempo completoJob Title: Senior Quality Assurance Automation EngineerJob Summary:We are seeking a highly skilled Senior Quality Assurance Automation Engineer to join our team at Adoreal. As a key member of our engineering team, you will be responsible for designing, developing, and deploying high-quality software solutions that meet the needs of our customers.Key...
-
Product Quality Engineer
hace 2 días
Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completoAbout the RoleAs a Product Quality Engineer at Boston Scientific, you will play a crucial role in ensuring the delivery of high-quality products to our customers. You will be responsible for providing process and quality engineering support to manufacturing or new product development teams, helping to identify manufacturing process defects and understand...
-
Senior Quality Assurance Automation Engineer
hace 1 mes
Paraíso, Paraíso, Costa Rica Independent Recruiter A tiempo completoJob Title: Senior Quality Assurance Automation EngineerAbout the Role:We are seeking a highly skilled Senior Quality Assurance Automation Engineer to join our team at Adoreal. As a key member of our engineering team, you will be responsible for designing, developing, and deploying best-in-class healthcare software.Responsibilities:- Collaborate with the team...
-
Quality Assurance Engineer
hace 6 días
Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completoJob Description:We are seeking a skilled Quality Assurance Engineer to support our manufacturing and new product development teams.Key Responsibilities:Identify and resolve manufacturing process defects, ensuring delivery of high-quality products to customers.Understand product quality plans, documents, and systems, including risk analyses and FMEAs.Monitor...
-
Quality Assurance Engineer
hace 4 semanas
Paraíso, Paraíso, Costa Rica Boston Scientific Corporation A tiempo completoAbout the Role:As a Quality Assurance Engineer at Boston Scientific Corporation, you will play a critical role in ensuring the delivery of high-quality products to our customers. Your primary responsibilities will include providing process/quality engineering support to manufacturing or new product development teams, helping to ensure the highest quality...
-
Senior Quality Systems Compliance Specialist
hace 7 días
Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completoAt Boston Scientific, we're driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges.About the RoleWe are seeking an experienced Senior Quality Systems Compliance Specialist to join our team...
-
Quality Assurance Specialist
hace 3 semanas
Paraíso, Paraíso, Costa Rica Heraeus A tiempo completoJob Title: Supplier Quality EngineerJob Summary:We are seeking a highly skilled and experienced Supplier Quality Engineer to join our team at Heraeus Medical Components. As a key member of our quality assurance team, you will be responsible for ensuring that our suppliers meet our quality standards and that our products are manufactured to the highest...
-
Quality Assurance Engineer II
hace 4 semanas
Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completoAs a Quality Assurance Engineer II at Edwards Lifesciences, you will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the company's systems and procedures. Your goal will be to optimize product development, internal and external device manufacturing, and device distribution.**Key...
-
Quality Assurance Specialist
hace 1 mes
Paraíso, Paraíso, Costa Rica Heraeus A tiempo completoJob OverviewHeraeus Medical Components is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring that our suppliers meet our quality standards and that our products are manufactured to the highest quality.Key ResponsibilitiesCoordinate the qualification of new...
-
Senior Quality Systems Improvement Specialist
hace 1 semana
Paraíso, Paraíso, Costa Rica Nextern A tiempo completoAt Nextern, we are seeking a highly skilled Senior Quality Systems Improvement Specialist to join our team. This role will play a critical part in maintaining and implementing process improvements to our Global Quality System (QMS) procedures, including supporting software configuration (Agile PLM).The ideal candidate will have experience with Quality System...
-
Microbiology Quality Engineer
hace 4 semanas
Paraíso, Paraíso, Costa Rica Boston Scientific Corporation A tiempo completo**About Boston Scientific Corporation**:Boston Scientific Corporation is a global medical technology leader with a passion for innovation that drives us to solve some of the most important healthcare industry challenges. We believe that our diversity and inclusion are key drivers of our success and that by embracing our unique backgrounds and perspectives,...
-
Quality Assurance Specialist
hace 1 mes
Paraíso, Paraíso, Costa Rica Heraeus A tiempo completoJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Heraeus. The successful candidate will be responsible for developing and implementing quality control plans and processes to ensure compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement quality control plans and processes to ensure...
-
Quality Assurance Specialist
hace 5 días
Paraíso, Paraíso, Costa Rica Heraeus A tiempo completoCompany Overview">">Heraeus, a leading provider of advanced materials and solutions, is seeking an experienced Quality Assurance Specialist to join our team. We are committed to excellence and innovation in our products and processes.Job DescriptionWe are looking for a highly motivated and organized individual to lead our Incoming Quality Area. The...
-
Quality Assurance Specialist
hace 3 semanas
Paraíso, Paraíso, Costa Rica Heraeus A tiempo completoKey Responsibilities: Develop and implement quality control plans and processes to ensure compliance with regulatory requirements. Lead and oversee process improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes. Collaborate with cross-functional teams to identify and resolve quality...