Quality Systems Lead

hace 6 días

San Francisco, Heredia, Costa Rica Bayer A tiempo completo

**Quality Systems Lead**

When you show proactivity and ambition, we'll harness it through a variety of opportunities and challenges in the diverse areas of our business - all with a strong and meaningful purpose.
Where do you want to go?
What do you want to do?
How do you want to make a difference?
The choice is yours, and we'll help you get there.
**Be better together.
Be Bayer**.
**YOUR TASKS AND RESPONSIBILITIES**

Deviations:

- Report, monitor and control CAPA/Deviations System metrics at the management level and development of trend analysis.
- Execute verification of effectiveness plans.
- Ensure adequate control of QMRB Cage and material disposition.
Internal/External Audits & Compliance:

- Lead internal audit program and execute audits to ensure compliance with regulations and international standards.
Support supplier audits when required.
- Report, monitor and control metrics related to CAPA/Deviations System and investigations derived from audits at the management level and development of trend analysis.
- Support external audits for regulatory bodies to meet local and international standards and Bayer Corporate Audits.
Follow up the adequate investigation process and CAPA implementation plans.
- Promote the GxPs in the company.
- Promote coordinated teamwork to achieve Data Integrity Standards.
Complaints:

- Responsible to oversee the analysis of complaints received from costumers, including the revision of history of the device and its tendency.
- Ensure complaints are processed within the established timeframes.
- Oversee the correct execution of cases by Gatekeeper and RQU.
Document Control Areas:

- Responsible to oversee Change Management Systems: Document Control,Training, External Documents/CMS Regulations & Master Control Administrator to provide quality systems development to meet Quality System requirements.
Environmental Monitoring:

- Manage Environmental Monitoring System and microbiological control.
- Plan and monitor budget.
- In charge of executing investigations of environmental control and coordinate the implementation of action plans in a timely manner.
- Responsible for developing validations of the environmental controlled room and/or process impacting the environmental control of clean rooms and/or equipment or auxiliary systems including CMSO approval process.
- Coordinate and/or execute the environmental monitoring.
Calibrations:

- Responsible to oversee calibrations area and ensure equipment is properly calibrated, and calibration is performed on time.
Reports:

- Responsible to lead the compilation, analysis and reporting of Quality Metrics (including but not limited to Management Review, KPIs, Quality Board and SQMR) to detect signals and anticipate potential non-conformities and to maintain key performance indicators as per quality objectives.
- Perform improvements as identified.
People:

- Responsible to lead direct reports such as Quality Systems Coordinator, Quality Engineer for Complaints and Quality Engineer Gatekeeper.
Others:

- Responsible for safeguarding all documents, confidential information, equipment, tools, raw materials, products or other assets directly related to their field of work, in order to avoid incidents that affect the productivity and distribution of our products that may cause economic impact for the company or a breach with our customers, suppliers, shareholders and / or other key audiences.
- Promote continuous improvement by identifying problems and development of projects to determinate the fundamental causes of the problems and definition and implementation of action plans.
- Act as approver in documents assigned in Master Control and some other quality related documents in paper based as required.
- Other duties can be assigned to the employee once the corresponding training is completed.
- Act as deputy for Management Representative.
**WHO YOU ARE**
- Bachelor´s Degree in Engineering (Industrial, Chemical, Mechanical, Electronics, Electrical), Microbiologist, Pharmacist or any other related career.
- At least 5 years of experience in the Quality Areas of a medical device company (mandatory).
- At least 3 years of experience supervising personnel.
- Advanced English level in reading, writing and speaking.
- Knowledge in Project Transfers and Validations.
- Strong knowledge in Statistical Techniques (DOE, Acceptance Sampling, SPC).
- Knowledge in Process/Product and Test Methods, Project Management, Failure Analysis.
- GxP and Data Integrity Requirements.
- ISO-13485, ISO-14644 & FDA auditing requirements.
- Extensive and strong problem solving, root-cause analysis and technical/engineering skills to lead and influence change are considered assets.
- High-level computer knowledge (Excel, Word, E-mail, Change Control, Power Point, SAP, Project, Visio, Minitab).
- CQE, Green or black belt (Desirable).
- Internal Quality Auditor.
- Strong leadership, conflict resolution, and negotiation skills required.
Capable of lead

  • Technical Lead for Enterprise Systems

    hace 4 días

    San Francisco, Heredia, Costa Rica Experian A tiempo completo

    About the RoleThis is an exciting opportunity for a Technical Lead for Enterprise Systems to join Experian's dynamic team. You will be responsible for leading the development of complex software systems, collaborating with cross-functional teams, and ensuring the delivery of high-quality solutions that meet customer needs.

  • Controllers Systems Quality Assurance Group Manager

    hace 2 horas

    San Francisco, Heredia, Costa Rica Citi A tiempo completo

    The Controllers Systems Quality Assurance Manager is a strategic professional accountable for management of complex/critical/large professional disciplinary areas.Leads and directs a team of professionals.Requires a comprehensive understanding of multiple areas within a function and how they interact to achieve the objectives of the function.Applies in-depth...

  • Senior Supplier Quality Lead

    hace 1 semana

    San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Job Overview**Boston Scientific Corporation is seeking an exceptional Senior Manager to lead a high-performing team of supplier quality engineers, driving material supply compliance with Global Medical Device regulations.The successful candidate will be responsible for onboarding, maintaining, and supporting material suppliers, investigating...

  • Process Quality Engineer

    hace 4 semanas

    San Francisco, Heredia, Costa Rica Bayer A tiempo completo

    **Process Quality Engineer****TASKS AND RESPONSIBILITIES**Quality System:- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.- Represent Quality by supporting quality disciplines, decisions, and practices.- Adhere to...

  • Quality Assurance Engineer

    hace 2 días

    San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo

    Job Overview:The Junior Quality Specialist Temporary will provide Quality Engineering support to the development and production of Class I and II Medical Devices. This role involves representing Quality in production process efforts, quality planning, FMEA and Risk Analysis, supporting new product development activities.Main Job Duties/Responsibilities:-...

  • Training and Quality Excellence Lead

    hace 3 días

    San Francisco, Heredia, Costa Rica Auxis A tiempo completo

    Key ResponsibilitiesThe Training and Quality Excellence Lead will play a key role in driving quality and excellence within our Service Desk. This individual will be responsible for developing and implementing comprehensive training programs to enhance the skills and knowledge of our team members.You will also be responsible for analyzing data and identifying...

  • Operations Quality Assurance Lead

    hace 7 días

    San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    Key ResponsibilitiesOversee the efficiency and standardization of operations;Directly responsible for production and product quality, as well as line personnel;Analyze and evaluate process improvements to reduce defects and scrap;Follow procedures established for each operation and keep work areas organized and clean at all times;Participate and/or lead...

  • Magento Expert Lead

    hace 2 días

    San Francisco, Heredia, Costa Rica Born Group A tiempo completo

    Job SummaryBorn Group is seeking an experienced Magento Technical Lead to join our team. As a Magento Technical Lead, you will be responsible for leading the development of complex ecommerce solutions using Magento 2, integrating with external systems, and collaborating with cross-functional teams.Key ResponsibilitiesLead the development of complex ecommerce...

  • Software Systems Engineer

    hace 1 semana

    San Francisco, Heredia, Costa Rica Hewlett Packard Enterprise A tiempo completo

    At Hewlett Packard Enterprise, we're dedicated to advancing the way people live and work. As a Software Systems Engineer, you'll play a crucial role in designing, developing, and troubleshooting software programs for our innovative IT services organization, HPE Pointnext.We're seeking an experienced professional with a strong analytical mind and excellent...

  • Global Quality Manager

    hace 1 semana

    San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

    **Quality Management at Boston Scientific**We are committed to delivering high-quality products that improve patient outcomes and advance medical science.In this role, you will play a critical part in ensuring our suppliers meet the highest standards of quality and regulatory compliance.As a Senior Manager, you will lead a team of supplier quality engineers,...

  • Quality Systems Specialist

    hace 7 días

    San Francisco, Heredia, Costa Rica Bayer A tiempo completo

    When you show proactivity and ambition, we'll harness it through a variety of opportunities and challenges in the diverse areas of our business - all with a strong and meaningful purpose.Where do you want to go?What do you want to do?How do you want to make a difference?The choice is yours, and we'll help you get there.Be better together.Be Bayer.YOUR TASKS...

  • Financial Services Quality Expert

    hace 1 semana

    San Francisco, Heredia, Costa Rica Citi A tiempo completo

    Financial Services Quality Assurance ExpertWe are seeking an experienced Financial Services Quality Assurance Expert to join our team at Citi. As a key member of our Financial Services Quality group, you will be responsible for supporting the Data Quality Assurance of financial systems and adherence to Citi's Data Governance Policies.Key...

  • Quality Engineer

    hace 4 semanas

    San Francisco, Heredia, Costa Rica Huber+Suhner A tiempo completo

    At HUBER+SUHNER, we design and create essential components that transport power and data through networks.This is how our employees around the globe contribute to a world where people get and stay connected.**Quality Engineer**:**Heredia** | **Full-time** | **Unlimited*****Your tasks**:- Directly responsible for ensuring all quality standards for products...

  • Hris Systems Analyst- Successfactors Recruiting

    hace 1 semana

    San Francisco, Heredia, Costa Rica Zm Financial Systems A tiempo completo

    Imagine what we can INSPIRE with youMoody's empowers people to make better decisions and achieve brighter futures.This is what motivates us to bring out the best in our products and our people.Join us.Forward Together.-- Moody's Shared Services are the front line professionals including Finance, Technology, Legal, Compliance and Human Resources, that...

  • Quality Engineer Junior Temporary

    hace 2 días

    San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo

    **Job Title**: Quality Engineer Junior Temporary**Department**: Quality Assurance- ____________________________________________**Main Purpose of Job**: (Brief Summary)- Provide Quality Engineering support to the development and production of Class I and II Medical Devices.Represent Quality in production process efforts, quality planning, FMEA and Risk...

  • Temporary Quality Control Lead

    hace 2 días

    San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo

    Key Performance Indicators (KPIs):- Compliance with FDA Quality Systems Regulation, ISO Standards and SOP's as defined by Vention's policies, practices and procedures.- Development and implementation of plans, programs and policies required to meet established objectives.- Participation in IQ/OQ/PQ activities including the drafting or review of protocols and...

  • Software Quality Engineering Lead

    hace 4 días

    San Francisco, Heredia, Costa Rica Experian A tiempo completo

    We're Experian Health, a leading provider of healthcare solutions. Our mission is to empower consumers and clients to manage their data with confidence.We're seeking a Software Quality Engineering Lead to join our team. In this role, you'll lead the development of comprehensive automated test suites providing maximum test coverage in the most efficient...

  • Data Governance Specialist

    hace 2 días

    San Francisco, Heredia, Costa Rica Zm Financial Systems A tiempo completo

    At Zm Financial Systems, we're inspired by the opportunity to empower organizations to make informed decisions with confidence.We're a global leader in providing financial data governance and ensuring data quality and usability. Our mission is to drive business growth through exceptional service.Job SummaryWe're seeking an experienced Data Governance...

  • Junior Quality Specialist Temporary

    hace 2 días

    San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo

    About the Role:Viant Medical is seeking a talented Junior Quality Specialist Temporary to join our team. In this role, you will be responsible for providing Quality Engineering support to the development and production of Class I and II Medical Devices. You will represent Quality in production process efforts, quality planning, FMEA and Risk Analysis,...

  • Regional Post Execution Quality Control Lead

    hace 1 semana

    San Francisco, Heredia, Costa Rica Citi A tiempo completo

    About CitiCiti is a global bank with a long history of innovation and excellence in the financial industry. As a leader in the Institutional Client Group, Citi provides KYC operational services to clients through state-of-the-art technologies that promote the collection, research, storage, and processing of KYC data.Job DescriptionWe are seeking a seasoned...