Quality Process Engineer

Varian Medical Systems; Juneau (AK, AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Varian is seeking a Quality Process Engineer to support process improvements across product development for cancer care solutions. You will work with cross-functional teams including Product, Project Management, Marketing, QA, Regulatory Affairs, R&D, Manufacturing, and Supply Chain to standardize workflows and ensure compliance in a global environment.

You will analyze needs, develop procedures and trainings, and implement standardized processes using content management systems to enable safe

Qualifications

• Bachelor’s degree in Engineering or a technical field.
• 3–4 years in the medical devices field.
• Proficient with Microsoft Office (Word, Excel, PowerPoint, Visio).
• Familiar with ISO 13485 and CFR 820.30 Design Controls.
• Experience authoring technical procedures and documentation.

Responsibilities

• Drive process changes and manage content for product development.
• Collaborate with cross-functional teams including QA, Regulatory, R&D, and Manufacturing.
• Analyze stakeholder needs and root causes to improve product lifecycle processes.
• Create and implement procedures, trainings, and frameworks to standardize workflows.

Skills

Microsoft Office

Documentation skills

Quality management familiarity

Cross-functional collaboration

Process improvement

Education

Bachelor’s Degree in Engineering or Technical Field

Tools

Visio

Product lifecycle management tools

Job description

Full job description Together, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. If you want to be part of this important mission, we want to hear from you.

Varian is seeking a Quality Process Engineer. The Quality Process Engineer shall work on the processes and content management systems that enable business and product development teams to conceptualize, realize, productionize, and obsolesce cancer care products, services, and technology. You will work directly with subject-matter-experts in cross-functional fields and roles, such as Product and Project Management, Marketing, Quality Assurance and Regulatory Affairs, Research and Development, Manufacturing, Services, Supply Chain, Clinical and Medical Affairs. You will need to collaborate with your new colleagues during primarily the US (PST/EST) time zone, and frequently in the EU (CET) time zone, and occasionally in the Asia and Asia Pacific time zones.

As a key player in process changes, you will facilitate projects that may include a team of subject-matter-experts and facilitate team efforts to identify stakeholder needs and root causes to pain points in the product lifecycle process or the technology solutions that enable them. Based on these needs you will be analyzing, creating, and implementing solutions, procedures, processes, trainings, and frameworks to standardize and enable product teams and the business to create and provide safe and effective cancer care solutions.

For this role, you should have a desire to:

• Being someone who wants to impact HOW we do things. Process engineering offers a strategic approach to continuous improvement, enabling development teams to innovate rather than just iterate.
• Learning and supporting our design and development processes, which includes quality standards and regulations, which are used by product/project teams to create and commercialize safe and effective medical devices.
• Working with technical subject-matter-experts to “connect the dots” and create easily understood and executed processes.
• Authoring and translating quality processes and best practices into procedures, work instructions, or guides that are followed by our global product development teams. Includes creating visuals and diagrams to support process understanding.
• Finding creative and effective solutions that enable the learning and understanding of best practices and quality processes.
• Working with software data/content management systems and tools that enable the product development process.
• Becoming a leader in change, inspired to learn and grow collaboratively.

Minimum Qualifications:

• Bachelor’s Degree in Engineering or Technical Field
• Minimum 3-4 years of experience working in Medical Devices field.
• Proficient with Microsoft Office software (Word, Excel, Powerpoint, Visio)
• Has worked on medical devices (preferably with hardware and software elements) or within an environment for medical devices and understands and/or was involved in the product development process.
• Need to have some familiarity with ISO 13485 and CFR 820.30 Design Controls and some experience working within a Quality Management System for Medical Devices.
• Should have had some experience in authoring and creating technical procedures and documentation.
• Need to have moderate knowledge base and skillset in the use of some technology platforms for product lifecycle management processes.

Fighting cancer calls for big ideas. We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer. TogetherWeFight

Equal Employment Opportunity Statement

Varian is an Equal Opportunity and Affimative 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.

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