Senior Quality Assurance Engineering Leader
hace 11 horas
Job Summary:
We are seeking an experienced Senior Quality Assurance Engineering Leader to join our team. In this role, you will be responsible for ensuring compliance with quality processes and regulations.
About Us:
Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, critical care, and surgical monitoring.
Key Responsibilities:
- Lead complex assessments, including audits, to ensure conformance with applicable regulations and policies.
- Assess objective evidence to determine conformity to requirements.
- Provide technical guidance and lead projects on quality initiatives, including designing and recommending systems.
- Plan annual audit schedules, assign SMEs, establish audit content, allocate time, and schedule meetings.
- Identify, lead, and implement business process improvement solutions for Quality Systems.
- Support teams on system usage and process requirements.
- Recommend changes to documentation associated with Quality Systems.
- Train, coach, and guide lower-level employees on procedures.
Education and Experience:
Bachelor's degree in engineering or a scientific field, 6 years of experience minimum, including either industry or education required. Master's Degree or equivalent in Engineering or Scientific field, 5 years of experience minimum, including either industry or education required. Ph.D. or equivalent in Engineering or Scientific field, 2 years of experience minimum of experience, including either industry or education required.
Additional Skills:
Proven expertise in MS Office Suite and experience with quality systems (e.g., CAPA, Ignite). Experienced in GxP. Good project management skills and related software tools preferred. Excellent written and verbal communication skills, including influencing and relationship management skills. Strong problem-solving and critical thinking skills. Ability to read, comprehend, write, and speak English fluently, required. Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems. Excellent knowledge of medical or pharmaceutical regulations as relating to documentation. Excellent understanding of medical devices regulations (e.g., FDA (21 CFR Part 820) and ISO13485, ISO14971, and MDD).
About Edwards Lifesciences:
Edwards Lifesciences is committed to helping patients by developing innovative medical technologies that improve their lives. We focus on creating new products and improving existing ones to address unmet healthcare needs. With extensive operations globally, we employ over 13,000 individuals worldwide who share our passion for making a difference in the lives of our patients.
-
Senior Quality Assurance Engineer
hace 4 días
Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completoJob SummaryWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Edwards Lifesciences. This is an excellent opportunity for someone with experience in quality engineering principles and methods to ensure compliance with regulatory requirements and optimize product development.About UsEdwards Lifesciences is a global leader in...
-
Senior Quality Assurance Specialist
hace 2 semanas
Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completoJob DescriptionWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Edwards Lifesciences. As a key member of our quality assurance department, you will play a crucial role in ensuring compliance with regulatory requirements and optimizing product development, manufacturing, and distribution.Key Responsibilities:Investigate...
-
Senior Quality Assurance Engineer
hace 1 día
Paraíso, Paraíso, Costa Rica Boston Scientific Corporation A tiempo completoAbout the RoleAs a Senior Quality Assurance Engineer at Boston Scientific Corporation, you will play a vital role in ensuring the delivery of high-quality products to our customers. This is an exciting opportunity for a quality professional to join our team and contribute to the success of our manufacturing or new product development teams.
-
Senior Quality Assurance Specialist
hace 3 semanas
Paraíso, Paraíso, Costa Rica Nextern A tiempo completoAt Nextern, we are seeking a Senior Quality Assurance Specialist to join our multidisciplinary product development and continuation engineering team.This role is responsible for the tactical management of the quality relationship between Nextern and key customers. The successful candidate will advocate for the customers' quality expectations and...
-
Senior Quality Assurance Manager, Medical Devices
hace 3 semanas
Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completoCompany Overview: Boston Scientific is a leading medical device company dedicated to improving lives through innovative solutions. With over 40 years of experience, we are committed to solving the most pressing healthcare challenges.Estimated Salary: $120,000 - $180,000 per yearJob Description: We are seeking an experienced Senior Quality Assurance Manager...
-
Senior Quality Assurance Engineer
hace 3 semanas
Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completoAbout the RoleWe are seeking a Senior Quality Assurance Engineer to drive improvement and corrective action in the quality of components sourced from outside suppliers. The ideal candidate will provide technical support in the selection of suppliers, develop acceptance criteria for materials, and monitor supplier performance.ResponsibilitiesAssess potential...
-
Senior Quality Assurance Specialist
hace 2 meses
Paraíso, Paraíso, Costa Rica Baxter A tiempo completoOverviewBaxter, a leading global healthcare company, is seeking a highly skilled Senior Quality Assurance Specialist to join our team. With a rich history of innovation and a commitment to improving patient outcomes, we are dedicated to transforming healthcare.
-
Quality Assurance Lead
hace 3 días
Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completoAbout the Role:We are seeking a Quality Assurance Lead with experience in process engineering to join our team. This is a critical role that requires strong leadership skills, technical expertise, and excellent communication abilities.Key Responsibilities:Lead the quality engineering team to achieve global quality objectivesIdentify manufacturing process...
-
Senior Quality Assurance Engineer
hace 1 mes
Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completoUnlock a Career in Quality and Innovation at Boston ScientificAbout the RoleWe're seeking a highly skilled Sr. Quality Assurance Engineer to drive improvement and corrective action in the quality of components sourced from outside suppliers.Your key responsibilities will include:Assessing potential new suppliers for technical, quality, and manufacturing...
-
Quality Assurance Manager
hace 11 horas
Paraíso, Paraíso, Costa Rica Innteci - Quid - Bgwi A tiempo completoCompany Overview">Innteci - Quid - Bgwi is an international company dedicated to providing services and developing administrative, management, and technology solutions for businesses in the public and private sectors. Our operations span Spain, the United States, Mexico, Central America, and South America.">Job Description">We are seeking a highly skilled...
-
Senior Quality Assurance Engineer
hace 3 días
Paraíso, Paraíso, Costa Rica Coloplast A tiempo completoJob Description">We are seeking a highly skilled Senior Quality Assurance Engineer - Process Validation to join our team in Cartago, Costa Rica. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and integrity of our products.">About the Role">In this challenging and rewarding position, you will be...
-
Quality Assurance Engineer II, Process Leader
hace 11 horas
Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completoAbout the RoleWe are seeking a Quality Assurance Engineer II to lead our quality assurance team in ensuring the highest standards of product quality and compliance.
-
Quality Assurance Specialist
hace 3 semanas
Paraíso, Paraíso, Costa Rica Coloplast A tiempo completoWe are seeking a Quality Assurance Specialist to join our team in Cartago, Costa Rica. The ideal candidate will have a bachelor's degree in Industrial Engineering, Quality, Production, Chemistry or equivalent and minimum 2 years of experience within medical device or manufacturing industry.The successful candidate will be responsible for ensuring compliance...
-
Senior Quality Assurance Specialist
hace 2 meses
Paraíso, Paraíso, Costa Rica Devlane A tiempo completoAt Devlane, a leading software development company with operations across Latin America and a strong presence in North America, we are seeking an experienced Senior Quality Assurance Specialist to join our team on a full-time remote basis.The ideal candidate will have a minimum of 3 years of experience working in quality assurance, with a strong background...
-
Quality Assurance Intern
hace 2 meses
Paraíso, Paraíso, Costa Rica Nextern A tiempo completo**ROLE OVERVIEW**At Nextern, we are seeking a highly motivated Quality Assurance Intern to support our Supply Chain Quality Engineering team. The ideal candidate will have advanced university studies in engineering or life sciences and a basic understanding of manufacturing, quality, and engineering processes in a highly regulated industry.**KEY...
-
Quality Assurance Specialist
hace 4 semanas
Paraíso, Paraíso, Costa Rica Straumann Group A tiempo completo**About Straumann Group**Straumann Group is a global leader in the field of esthetic dentistry and dental implants. Our innovative products and solutions empower dental professionals to provide high-quality treatment options for their patients.We are seeking a highly skilled Quality Assurance Specialist to join our team in Heredia, Costa Rica. As a key...
-
Technical Quality Assurance Engineer
hace 11 horas
Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completoAt Edwards Lifesciences, we are driven by a passion to help patients.We are seeking a Technical Quality Assurance Engineer to join our team, providing operational support for product and technology transfer activities, as well as running operations for Component manufacturing.Maintaining and operating components, parts, and subassemblies processes is a key...
-
Product Quality Assurance Specialist
hace 4 semanas
Paraíso, Paraíso, Costa Rica Nextern A tiempo completoJob Description: We are seeking a skilled Product Quality Assurance Specialist to join our team at Nextern. The successful candidate will be responsible for ensuring customer quality expectations and daily requirements in engineering, production development, and supply chain are met.About the Role:Manage quality requirements between Nextern and key...
-
Senior Quality Assurance Engineer
hace 2 meses
Paraíso, Paraíso, Costa Rica Boston Scientific Corporation A tiempo completoJob SummaryWe are seeking a highly skilled Senior Quality Assurance Engineer to support our manufacturing operations in Cartago. As a key member of our quality team, you will be responsible for ensuring the highest quality products are delivered to our customers.ResponsibilitiesEstablish and implement quality control procedures to ensure compliance with...
-
Quality Assurance Manager
hace 1 mes
Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completoAbout the RoleBoston Scientific is committed to advancing science for life, and we're looking for a talented Quality Assurance Manager to join our team. As a leader in medical science for over 40 years, we're passionate about solving the challenges that matter most – united by a deep caring for human life.