Quality Engineering Director Lead

hace 2 días


Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

About the Role

We are seeking an experienced Senior Director, Quality Engineering to join our team at Edwards Lifesciences. As a key member of our quality organization, you will play a critical role in ensuring the highest standards of integrity and safety in our innovation process.

As a Senior Director, Quality Engineering, you will be responsible for leading a team of quality engineers who are responsible for various activities such as process and test methods validations, product transfer, process improvements, non-conformance investigation, corrective action, product disposition, complaint analysis, and risk management. You will also develop quality processes, staffing, planning, budgeting, align priorities, performance management, and work through managers to achieve results.

Key Responsibilities

  • Lead a team of quality engineers responsible for various activities such as process and test methods validations, product transfer, process improvements, non-conformance investigation, corrective action, product disposition, complaint analysis, and risk management.
  • Develop quality processes, staffing, planning, budgeting, align priorities, performance management, and work through managers to achieve results.
  • Drive a culture that is focused on quality and business results.
  • Create an environment that fosters employee motivation and engagement.
  • Plan, prioritize, and direct strategic program activities including product, process, and quality projects using engineering methods such as Six Sigma and LEAN methods to align with applicable compliance standards.
  • Collaborate with leadership to develop operational strategy.
  • Partner with cross-functional groups/resources to achieve tactical execution of business objectives.

Requirements

  • Bachelor's Degree related field with experience in engineering and skill levels exceeding the requirements of the Director, experience in quality engineering, quality management, and regulatory compliance within the medical device industry.
  • Proven successful project management leadership skills.
  • Proven expertise in both Microsoft Office Suite and related systems.
  • Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
  • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
  • Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems.
  • Expert understanding of related aspects of quality engineering processes and/or systems.
  • Expert knowledge of domestic and international regulatory requirements such as FDA, GMPs, and ISO/EN standards.
  • Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing.
  • Knowledge of financial acumen as it relates to the business as well as quality engineering.
  • Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.
  • Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business.


  • Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

    About the PositionWe have an excellent opportunity for a Senior Director, Quality Engineering to join our quality organization at Edwards Lifesciences. As a key member of our team, you will play a critical role in ensuring the highest standards of integrity and safety in our innovation process.As a Senior Director, Quality Engineering, you will lead a team...


  • Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

    Edwards Lifesciences is seeking an Engineering Quality Manager to lead our quality assurance efforts. As an Engineering Quality Manager, you will be responsible for developing and implementing quality systems and processes to ensure compliance with regulatory requirements.Key Responsibilities:Develop and maintain quality policies and procedures.Lead...

  • Engineering Director

    hace 3 días


    Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo

    About the OpportunityThis is an exciting opportunity to join Boston Scientific as an Engineering Director - Operations Excellence. In this role, you will be responsible for developing and implementing strategies to improve operational excellence across the organization. Your responsibilities will include leading cross-functional teams, developing process...


  • Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo

    About the RoleAt Boston Scientific, we are committed to advancing science for life. As a Quality Systems, Sr Manager, you will have the opportunity to lead a cross-functional team in developing procedures that will lead to a successful launch of a PMA product containing MOAO and prepare the manufacturing site to host successful inspections by FDA and...


  • Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo

    Executive Summary">The Engineering Operations Director will be responsible for leading cross-functional teams to drive business results, improve efficiency, and enhance customer satisfaction.">Key responsibilities include:">Developing and implementing strategic plans to drive business growth and improve operational performance.">Leading and coordinating...


  • Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

    About the JobWe have an exciting opportunity for a Senior Director, Quality Engineering to join our quality organization at Edwards Lifesciences. As a key member of our team, you will play a critical role in shaping the development of groundbreaking technologies and ensuring the highest standards of integrity and safety in our innovation process.As a Senior...


  • Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

    About UsEdwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We collaborate with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.The JobWe are seeking a highly...


  • Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo

    About the RoleAs a Senior Manufacturing Engineering Lead at Boston Scientific, you will have the opportunity to drive complex initiatives that support daily operations, ensuring the delivery of high-quality products while meeting production goals. Your responsibilities will include leading cross-functional teams, developing new techniques and procedures, and...


  • Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo

    Main Responsibilities:Develop and implement quality engineering methodologies, systems, and practices to ensure compliance with regulatory requirementsServe as a quality representative to improve awareness, visibility, and communication on quality initiativesProvide focused quality engineering support within new product development, operational, or...


  • Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

    About Edwards LifesciencesWe are a global leader in medical innovations for structural heart disease and critical care. Our mission is to help patients by collaborating with leading clinicians and researchers to address unmet healthcare needs.We develop devices that replace or repair diseased heart valves, as well as create technologies that monitor vital...

  • Quality Engineer

    hace 7 días


    Paraíso, Paraíso, Costa Rica Nextern A tiempo completo

    This position is responsible for tactically managing quality requirements between Nextern and key customers, ensuring customer quality expectations and daily requirements in engineering, production development, and supply chain, balancing responsibility between areas to achieve product quality performance and in compliance with company requirements and...


  • Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

    Job DescriptionThis Site Facilities Manager role is responsible for leading the day-to-day facilities operations in our Costa Rica manufacturing site. The successful candidate will have a strong background in facilities management, with a focus on reliability and efficiency.Duties and Responsibilities:Lead the development and implementation of a...


  • Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

    About the Role:">We are seeking a skilled Senior Quality Engineering Specialist to join our team at Edwards Lifesciences. In this role, you will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and optimize product development, internal and external device manufacturing, and device distribution.

  • Engineering Team Lead

    hace 6 días


    Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

    Job Summary:The Plant Operations Manager will lead a team of engineers to ensure smooth and continuous operations in the engineering department. Key responsibilities include managing and directing operational and project activities, identifying opportunities for improvement, creating complex engineering documents, developing team members, and analyzing...


  • Paraíso, Paraíso, Costa Rica Nextern A tiempo completo

    **Job Overview**Nextern is a leading organization in the manufacturing industry, and we are currently seeking a highly skilled Quality Engineer to join our team. This role will play a crucial part in ensuring that our products meet the highest quality standards.About the RoleThe successful candidate will be responsible for managing quality requirements...


  • Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo

    About the JobThis role requires a Quality Systems, Sr Manager with strong project management skills and 10 years of medical experience. The ideal candidate will have experience hosting quality audits/FDA inspections and knowledge of Six Sigma, Lean, APQP, or similar tools.Key RequirementsA bachelor's degree or above in a technical/science career (Industrial,...

  • Engr I, Quality

    hace 5 días


    Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

    Supervise employees and activities across areas of quality.**Key Responsibilities**:- Supervise employees and quality activities pertaining to the production of products and/or manufacturing processes in - and with quality/technical knowledge of 2 or more production areas, depending on the complexity of the areas, in addition to conducting performance...


  • Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo

    Job SummaryWe are seeking an experienced Quality Engineer to join our team as a Sr. Quality Engineer in Coyol, Costa Rica. As a member of our quality assurance team, you will play a key role in developing, establishing, and maintaining quality engineering methodologies, systems, and practices that meet regulatory requirements.


  • Paraíso, Paraíso, Costa Rica Boston Scientific A tiempo completo

    Job Description:As a Strategic Project Director at Boston Scientific, you will be responsible for leading approved projects in the Global Business Services organization. These projects vary in size and scope but may include supporting business process improvements, service transitions & acquisitions, quality/regulation driven project work, as well as driving...


  • Paraíso, Paraíso, Costa Rica Nextern A tiempo completo

    Nextern is seeking a highly skilled Manufacturing Engineer to lead our engineering project management efforts. As a key member of our team, you will be responsible for coordinating product improvements, addressing manufacturing issues, and managing the product lifecycle. This role requires strong leadership and project management skills, as well as the...