Job Description

Locations

• Poland, Warsaw

Skills Required

• medical deviceintermediate
• interacting with regulatory agenciesintermediate
• Good Manufacturing Practicesintermediate
• Excel spreadsheetsintermediate
• training needs analysisintermediate

Required Qualifications

• Bachelor’s degree in Business, Education, Human Resources, or related discipline. (degree in business)
• Bachelor’s degree in Business, Education, Human Resources, or related discipline. (degree in business)
• Minimum of 5 years of experience in medical device, supporting quality, compliance, manufacturing, operations, or technical training programs. (experience, 5 years)
• Minimum of 5 years of experience in medical device, supporting quality, compliance, manufacturing, operations, or technical training programs. (experience, 5 years)
• Experience managing one or more remote team members. (experience)
• Experience managing one or more remote team members. (experience)
• Ability to work with repetitive, detail-oriented tasks that require a high degree of accuracy (degree)
• Ability to work with repetitive, detail-oriented tasks that require a high degree of accuracy (degree)
• Strong understanding of QMS requirements (experience)
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) (experience)
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) (experience)
• Fluent in written and oral English – C1 Level (writing documents, meeting minutes, conference calls, etc.) (experience)
• Fluent in written and oral English – C1 Level (writing documents, meeting minutes, conference calls, etc.) (experience)
• Knowledge of Good Manufacturing Practices (GMPs) and ISO 13485 regulations. (experience)
• Knowledge of Good Manufacturing Practices (GMPs) and ISO 13485 regulations. (experience)
• Well versed with MS Office tools such as Word and PowerPoint; highly proficient with Excel spreadsheets. (experience)
• Well versed with MS Office tools such as Word and PowerPoint; highly proficient with Excel spreadsheets. (experience)

Preferred Qualifications

• Experience supporting training programs within manufacturing, supply chain, logistics, procurement, or sales operations environments. (experience)
• Experience supporting training programs within manufacturing, supply chain, logistics, procurement, or sales operations environments. (experience)
• Knowledge of training needs analysis, instructional design, adult learning principles, training evaluation methods, and eLearning development. (experience)
• Knowledge of training needs analysis, instructional design, adult learning principles, training evaluation methods, and eLearning development. (experience)
• Demonstrated ability to deliver instructor-led training at a high level. (experience)
• Demonstrated ability to deliver instructor-led training at a high level. (experience)
• Demonstrated ability to work well in a fast-paced environment. (experience)
• Demonstrated ability to work well in a fast-paced environment. (experience)
• C1 German language skills (written and spoken) (experience)
• C1 German language skills (written and spoken) (experience)

Responsibilities

• Lead and develop a team responsible for the coordination, deployment, and management of role-based technical training programs.
• Lead and develop a team responsible for the coordination, deployment, and management of role-based technical training programs.
• Ensure Quality Key Performance Indicators (KPIs), training processes, records, and curricula comply with regulatory requirements, quality standards, and internal procedures.
• Ensure Quality Key Performance Indicators (KPIs), training processes, records, and curricula comply with regulatory requirements, quality standards, and internal procedures.
• Complete training workflow tasks within the Change Control process to ensure accurate training is planned and assigned in the LMS when new or revised documents are released.
• Complete training workflow tasks within the Change Control process to ensure accurate training is planned and assigned in the LMS when new or revised documents are released.
• Develop, maintain, evaluate, and continuously improve training systems, standards, and processes to ensure effective training delivery and overall program effectiveness.
• Develop, maintain, evaluate, and continuously improve training systems, standards, and processes to ensure effective training delivery and overall program effectiveness.
• Partner with functional groups (e.g., Manufacturing, Quality, Regulatory, Compliance, HR) to incorporate functional training requirements into role-based curricula and ensure accurate training assignments.
• Partner with functional groups (e.g., Manufacturing, Quality, Regulatory, Compliance, HR) to incorporate functional training requirements into role-based curricula and ensure accurate training assignments.
• Present training performance metrics to leadership during periodic meetings and forums (e.g., Quality Systems Management Review).
• Present training performance metrics to leadership during periodic meetings and forums (e.g., Quality Systems Management Review).
• Review, approve, and execute training-related QMS change control tasks.
• Review, approve, and execute training-related QMS change control tasks.
• Monitor and respond to changes in LMS data that may impact the reliability and/or automation of training assignments.
• Monitor and respond to changes in LMS data that may impact the reliability and/or automation of training assignments.
• Update training procedures, plans, and supporting documentation as required.
• Update training procedures, plans, and supporting documentation as required.
• Represent Technical Training processes during regulatory audits and inspections, providing training records and qualification evidence as needed.
• Represent Technical Training processes during regulatory audits and inspections, providing training records and qualification evidence as needed.
• Provide support for NC/CAPAs related to training outcomes or training processes.
• Provide support for NC/CAPAs related to training outcomes or training processes.
• Perform additional duties and projects as assigned.

Benefits

• general: Poland: zł191.100 - zł318.500 PLN Annual
• general: At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.
• general: If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.

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