Senior Director, Quality Engineering

hace 7 meses

Cartago, Costa Rica Edwards Lifesciences A tiempo completo

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an impact:
• Direct a team with responsibilities for quality engineering activities (e.g., process and test methods validations, product transfer, process improvements, non-conformance investigation, corrective action, product disposition, complaint analysis, risk management) with overall responsibility of developing quality processes, staffing, planning, budgeting, aligning priorities, performance management, and working 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 (e.g., Six Sigma and LEAN methods) to align with applicable compliance standards. Lead in identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups.
• Collaborate with leadership to develop operational strategy. Partner with cross-functional groups/resources to achieve tactical execution of business objectives.
• Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material.
• Identify and lead efforts to optimize quality engineering processes and define and implement core competencies, by assessing business needs to develop, propose and implement solution options.
• Develop robust talent development and succession planning in alignment with functional growth strategies across the quality organization.
• Collaborate and align with network and COE teams in driving standardized programs and/or processes.
• Provide quality engagement to audits including resources support, technical and procedural expertise, presentation of information, and effective resolution of issues.
• Other incidental duties

What you’ll need (required):
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.

What else we look for (preferred):
• 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 (e.g., 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
• Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Interacts with senior management, and others concerning matters of significance to the company
• Conduct business and technical briefings for senior and top management and for external representatives
• Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization
• Dedicated to quality client service and pro-active and responsive to client needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels within the organization
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

  • Senior Director, Quality Engineering

    hace 6 meses

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for...

  • Quality Director Cartago

    hace 4 meses

    Provincia de Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Location(s)**: Costa Rica-Coyol**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science...

  • Quality Engineering Intern

    hace 5 meses

    Cartago, Costa Rica Nextern A tiempo completo

    **INTERNSHIP SCOPE** The Quality Engineering Intern will be supporting critical programs related to monitoring and follow up corrective actions for the incoming inspection area. The Intern will have high exposure to multidisciplinary teamwork and relationships. This role will develop and implement best practices focused on preventing defects, reducing...

  • Quality Engineering Intern

    hace 3 semanas

    Cartago, Costa Rica Nextern A tiempo completo

    INTERNSHIP SCOPEThe Quality Engineering Intern will be supporting critical programs related to monitoring and follow up corrective actions for the incoming inspection area. The Intern will have high exposure to multidisciplinary teamwork and relationships. This role will develop and implement best practices focused on preventing defects, reducing...

  • Intern Supplier Quality Engineering

    hace 5 meses

    Cartago, Costa Rica Nextern A tiempo completo

    **INTERNSHIP SCOPE** The Intern Supplier Quality Engineer will be supporting critical programs related to supplier selection, approval, monitoring and follow up corrective action management, and development. The Intern will have high exposure to multidisciplinary teamwork and relationship management with local and international suppliers. This role will...

  • Manufacturing Engineer Director

    hace 4 semanas

    Cartago, Costa Rica Boston Scientific A tiempo completo

    Additional Locations:  N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion,...

  • Senior Quality Engineer

    hace 4 meses

    Cartago, 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...

  • Quality Engineer

    hace 4 meses

    Cartago, 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...

  • Quality Engineer

    hace 4 meses

    Cartago, Costa Rica Nextern A tiempo completo

    JOB BRIEFING **Our Quality Engineers are a key part of a multidisciplinary product development and continuation engineering team. Specifically, Operations Quality is key to establishing and sustaining our business culture of continuous improvement by leveraging data to improve processes, eliminate waste, and compel the business and our customers to take...

  • Quality Pocess Engineer

    hace 4 meses

    Cartago, Costa Rica Heraeus A tiempo completo

    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 issues and drive...

  • Engineer Ii, Quality

    hace 5 meses

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Key Responsibilities**: - Investigate moderately complex manufacturing product quality and compliance issues...

  • Quality Technician Shift A

    hace 5 meses

    Cartago, Costa Rica Nextern A tiempo completo

    The main purpose of this job is to perform semi-standardized or semi-prescribed tasks that require judgment and problem solving skills. In charge of updating and reviewing standard procedures or equipment. Receive initial instructions and technical advice from direct supervisor. The position is also responsible for supporting the monitoring of compliance...

  • Quality Technician Shift A

    hace 5 meses

    Cartago, Costa Rica Nextern A tiempo completo

    The main purpose of this job is to perform semi-standardized or semi-prescribed tasks that require judgment and problem solving skills. In charge of updating and reviewing standard procedures or equipment. Receive initial instructions and technical advice from direct supervisor. The position is also responsible for supporting the monitoring of compliance...

  • Quality Technician Shift B

    hace 5 meses

    Cartago, Costa Rica Nextern A tiempo completo

    The main purpose of this job is to perform semi-standardized or semi-prescribed tasks that require judgment and problem solving skills. In charge of updating and reviewing standard procedures or equipment. Receive initial instructions and technical advice from direct supervisor. The position is also responsible for supporting the monitoring of compliance...

  • Senior Process Development Engineer

    hace 4 meses

    Cartago, Costa Rica Nextern A tiempo completo

    SUMMARYA senior process development engineer will play a key role in planning , developing , and optimizing manufacturing processes to improve efficiency, quality and cost-effective for production systems, to enhance the speed and quality of processing, and ensure produced items comply with international regulations and industry standards. This role may...

  • Mgr Quality Operations

    hace 4 meses

    Cartago, Costa Rica Terumo BCT A tiempo completo

    Job summary: Leads specified Quality Team supervising execution of key quality processes at the manufacturing facility. The Quality Operations Manager will play an integral role in ensuring the ability to produce a high-quality product, processes are aligned with regulations and standards which are aligned efficiently and compliantly with policies and...

  • Engr I, Quality

    hace 4 meses

    Provincia de Cartago, 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...

  • Quality Engineer Ii

    hace 4 meses

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Key Responsibilities**: - Investigate moderately complex manufacturing product quality and compliance issues...

  • Quality Engineer Ii

    hace 5 meses

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Key Responsibilities**: - Investigate moderately complex manufacturing product quality and compliance issues...

  • Prin Engr, Quality Systems

    hace 4 meses

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Ensure compliance of the QMS and compliance within quality processes (e.g., CAPA. NCR, ECR, internal and external auditing, training). Maintain quality reporting inclusive quality and production indicators. **Key Responsibilities**: - Provide complex assessments including audits to ensure conformance with applicable regulations and EW policies and...