Design Quality Engineer

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.

The Design Quality Engineer will participate in the governance, and execution of the Quality Management sub-system element of Product Realization. This is a hybrid role in Ottawa.

Specifically, this individual will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems compliance regarding product design and development activities. Additionally, this role will lead specific quality improvement projects as required to support QT and other business initiatives including, but not limited to audits (internal / external), supplier quality, CAPA, and training. The individual filling this role is expected to apply advanced problem-solving techniques and interpersonal skills and be able to influence and drive results.

Major Job Responsibilities

• Participate as a core team member on various design and development project activities;
• Provide strategic oversight on design and development projects in specific regard to design verification, design validation, and design change requirements;
• Provide assistance to the engineering partners in the development of design verification and validation testing requirements including protocol development, test methods, acceptance criteria, and statistical plans / techniques;
• Support the development, monitoring and reporting of Quality Systems key performance indicators (KPIs), which will include assisting in the development of Quality Goals & Objectives across POC.
• Support internal and external audit needs while serving as the subject matter expert for Design Quality Assurance

Required Knowledge/Skills, Education, and Experience

5 years of experience in a Quality Engineering or similar role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes. ASQ certifications such as CQA, CRE, Six Sigma, CQE, CQT or equivalent are highly desirable.

Job Family Responsibilities:

• Analyze complex production and quality trend data to identify and solve problems.
• Designs and develops systems for recording, evaluating, and reporting quality data.
• Performs economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments.
• Conducts complex audits and/or surveys to determine acceptability of quality controls

Education:

• Typically BS degree in a related discipline or equivalent combination of education and experience (Engineering (electrical / mechanical), Biochemistry or Chemistry, Physics, or other technical field.)
• Preferred candidates will possess internal auditor certification (CQA) from ASQ or equivalent training in IVD / biomedical industry.

Knowledge and Experience:

• Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments.
• Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization.
• Demonstrates knowledge of organization's business practices and issues.

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 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.

The base pay range for this position is:

Base pay offered may vary depending on job-related knowledge, skills, and experience. Siemens Healthineers  offers a variety of health and wellness benefits including paid time off and holiday pay.  

This information is provided per the required laws and regulations. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.

Equal Employment Opportunity Statement: Siemens Healthineers 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.

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