Quality Systems & Training Specialist

Siemens Healthineers; Knoxville (TN); On-site; USD 74,000 - 102,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term and short-term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers in Knoxville is seeking a Quality Systems & Training Specialist to ensure we equip employees with the knowledge, training, and resources for operating in a regulated medical device environment.

You will develop and deploy engaging training, support the LMS, and drive audit readiness, metrics, and Quality Management System initiatives across functions.

Qualifications

• Bachelor’s degree or equivalent combination of education and relevant experience.
• Minimum 1 year of experience in the medical device industry.
• Experience with Articulate and/or Adobe Captivate for training.
• Experience in a regulated environment with training and quality processes.
• Strong organizational and communication skills; MS Office proficiency.

Responsibilities

• Create, develop, and deploy training content to support Quality and business requirements.
• Manage employee accounts, training assignments, and user roles in the LMS.
• Collaborate with cross-functional departments to review and update training content.
• Respond to inquiries from business partners about training requirements.
• Generate and maintain daily/weekly/monthly training reports and metrics.
• Prepare training documentation and records for audit readiness and compliance.
• Support inspections and audits with required training documentation.
• Assist in continuous improvement and automation of Quality Management System processes.
• Collaborate with Quality and other teams to improve training effectiveness and efficiency.

Skills

LMS administration

Training content development

Articulate

Adobe Captivate

Regulatory compliance

Education

Bachelor's degree or equivalent

Tools

Learn4U LMS

SAP document control

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

At Siemens Healthineers, we are looking for a Quality Systems & Training Specialist who will play an important role in ensuring our employees have the knowledge, training, and resources needed to successfully operate within a highly regulated medical device environment.

In this role, you will be responsible for developing and deploying engaging training content, supporting our Learning Management System, and partnering with teams across the organization to maintain effective and compliant training programs. You will also support audit readiness, training metrics and reporting, Quality Management System initiatives, and process improvement efforts. This is a great opportunity for someone who enjoys combining training and development with quality and compliance and is looking to continue growing their career within Siemens Healthineers. You will have the opportunity to work cross-functionally, contribute to continuous improvement initiatives, and help strengthen the processes that support quality throughout the organization.

You are responsible for:

• Creating, developing, and deploying training content and processes to support Quality and business requirements.
• Managing employee accounts, training assignments, and user roles within the Learning Management System (LMS).
• Partnering with cross-functional departments to review, update, and approve training content.
• Responding to inquiries and requests from business partners regarding training requirements and activities.
• Generating and maintaining daily, weekly, and monthly training reports and metrics to support business needs.
• Preparing training documentation and records to support audit readiness and compliance.
• Supporting internal and external inspections and audits by providing required training documentation and information.
• Supporting continuous improvement initiatives and special projects, including the automation and optimization of Quality Management System processes.
• Collaborating with Quality and other functional teams on initiatives designed to improve training effectiveness, compliance, and operational efficiency.

This position may suit you best if:

• Knowledge of e-learning authoring tools used to create and deploy training content, including Articulate and/or Adobe Captivate.
• Familiarity with SAP as a document control tool.
• Familiarity with Learn4U or similar Learning Management Systems.
• Understanding of Quality Management Systems within the medical device industry.
• Knowledge of applicable medical device quality standards and regulatory requirements, including ISO 13485, MDSAP, MDD, and MDR.
• Experience supporting internal or external audits and inspections.
• Experience preparing, analyzing, and communicating training metrics and reports.
• Interest in process improvement and the automation of Quality System processes.
• Ability to work effectively with cross-functional stakeholders in a regulated environment.

Required Qualifications:

• Bachelor’s degree or equivalent combination of education and relevant experience.
• A minimum of 1 years of experience within the medical device industry.
• Experience developing training content using authoring tools such as Articulate and/or Adobe Captivate.
• Experience working within a regulated environment and supporting established training and quality processes.
• Strong organizational skills with the ability to manage multiple priorities and assignments simultaneously.
• Strong written and verbal communication skills with the ability to collaborate effectively across departments.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Access.

Who we are:

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become part of a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

The base pay range for this position is: $74,350 - $102,234 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

Benefits:

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time

Equal Employment Opportunity Statement:

Siemens Healthineers is an Equal Opportunity and Affiantive Action Employer encouraging diversity in the workplace.

All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Reasonable Accommodations:

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

California Privacy Notice:

California residents have the right to receive additional notices about their personal information.

Export Control:

A successful candidate must be able to work with controlled technology in accordance with US export control law. It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

Data Privacy:

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask that you not send us your CV or resume by email.