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.
A member of the Quality and Compliance team responsible for reviewing and approving Design Control documentation and driving improvements in Product Lifecycle processes for standalone software, with a focus on EMR and treatment support software products on a cloud platform
You are responsible for:
- Participating as an independent reviewer on cross-functional teams to review and approve design control documentation, including software design and development plans and related design inputs and design outputs, with emphasis on quality by design.
- Partaking in Discrepancy Report Review Board to ensure that product defects/complaints are reviewed, diagnosed and handled in a prompt, consistent and compliant manner.
- Analyzing customer complaint data and provide analysis to engineering teams to develop methods, processes, procedures and equipment that will improve the failure analysis process and/or reduce failures.
- Identifying improvement opportunities on SOPs and work with cross functional team to implement the changes/updates in processes, procedures, and work instructions.
- Reviewing and follow-up on design control process-related audit non-conformances, CAPAs and customer complaints/field problems, to establish a closed-loop system.
Minimum Qualifications:
- BSc in a relevant field (Engineering, Computer Science, Sciences) and 3+ years of experience in a Software Engineering function, or Quality Assurance function, preferably with products operating on a cloud platform
- Experience in Software Development, preferably with EMR and treatment support software products
- Excellent technical writing and oral communication skills
- Ability to plan, organize, and implement concurrent tasks and project
- Excellent organizational, problem-solving, and analytical skills
- Experience working in a cross-functional team environment
- Ability to influence and interact with cross-functional team members
- Ability to manage priorities in a fast-paced environment
- Proficiency utilizing business tools such as e-mail, Microsoft Word, Excel, and PowerPoint, and other productivity software
The following experience would be considered an asset or the applicant should be willing to acquire on-the-job as follows:
- Understanding of and/or experience auditing to standards or regulations such as ISO 9001, ISO 13485, ISO 14971, IEC 62304, the FDA Quality System Regulation, Medical Device Directive and/or Canadian Medical Device Regulation
- Experience with cybersecurity standards or requirements
- Experience in Risk Management
Who we are: We are a team of more than 73,000 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 one in 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.
To find out more about Siemens Healthineers' businesses, please visit our company page at Siemens Healthineers Canada.
Equal Employment Opportunity Statement: Siemens Healthineers Canada Limited is committed to creating a diverse environment and is proud to be an equal opportunity employer. While we appreciate all applications we receive, we advise that only candidates under consideration will be contacted.
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, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [email protected]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.
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 you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.
By submitting personal information to Siemens Canada Limited or its affiliates, service providers and agents, you consent to our collection, use and disclosure of such information for the purposes described in our Privacy Notice here.
To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.
