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LOCATION: Salt Lake City, UT (onsite)
JOB SUMMARY
The Quality Engineer will lead cross-department collaboration and be the Subject Matter Expert in Quality adjacent project activities in other departments. The Quality Engineer will consult on projects, offering expertise on matters related to quality, design controls, and risk.
PRINCIPAL DUTIES & RESPONSIBILITIES | Â |
1. | New Product Development (75%)
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2. | Non-medical Manufacturing Control (15%)
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3. | Quality Management / Continuous Improvement (10%)
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QUALIFICATIONS
Education/Experience
- Knowledge and skills at a level normally acquired through the completion of a Bachelor’s degree in Engineering or related fields.  Advanced degree not required but useful.
- Experience with Quality Management Systems within the context of medical device developmentÂ
- Experience with ISO 13485, ISO 14971 and 21CFR820
- Experience with statistical analysis preferred
Licenses/Credentials/Certifications
- N/A
Skills/Specialized Knowledge/Abilities
- Associate’s or Bachelor’s degree in Engineering or related field
- 7-9 years of experience preferred
- High attention to detail in striving for excellence in processes, deliverables and execution
- Maintains rational and objective demeanor/actions when faced with stressful and/or emotional situations
- Manages competing demands and balancing multiple priorities while ensuring deadlines are met
- Strong inclination for continuous improvement
- Works well independently as well as collaboratively with colleagues and clients
- Demonstrated ability to write and prepare documents/reports/correspondence in a concise, logical, grammatically appropriate format
- Demonstrated ability to handle sensitive information with discretion and tact
- Proficient with Microsoft Office applications: (Word, Excel, PowerPoint, Access, Outlook)
WORKING CONDITIONS
Tools and Equipment Used
- Computer, copier, phone, and other typical office equipment
Travel
- Minimal: up to 10% of the time
Physical & Mental Demands
- Frequently required to sit at a desk/workstation for extended period of time
- Ability to work at a computer terminal for extended periods of time
- Digital dexterity and hand/eye coordination in operation of office equipment
- Moderate lifting and carrying of supplies, files, etc.
- Ability to speak to and hear employees/clients via phone or in person
- Body motor skills sufficient to enable incumbent to move around the office environment
- Ability to analyze unique situations and develop appropriate response
- Additional Physical Requirements: Â file, speak, write, listen, read, type, understand
- Additional Mental Requirements: compare, decide, direct, problem solve, analyze, instruct, interpret
Environment
- Work typically performed in an office setting.
Kaleidoscope, an Infosys Company, is an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability.
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