Quality Engineer

*Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.*

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

1.

New Product Development (75%)

• Work with internal project teams to develop defined risks for both the project and product
• Identify Design Control needs in collaboration with the project team
• Monitor, advise, and approve progress of Design Control related documents
• Initiate standards and methods for inspection, testing, and evaluation
• Identify and/or perform best-fit statistical analysis for product data
• Provide feedback to Design Engineers on how to improve quality and meet product specifications
• Design and implement test procedures as necessary, review test standards for industry best practices
• Create and execute software V&V protocols on software used for product development
• Develop risk-based sampling plans for testing and inspection
• Initiate improvements in product development procedures for best practices and increased compliance
• Lead or assist with risk / FMEA workshops
• Act as a Quality subject matter expert for employees in the product development space

2.

Non-medical Manufacturing Control (15%)

• Work with internal project teams to develop defined risks for both the project and product
• Initiate standards and methods for inspection, testing, and evaluation
• Develop risk-based sampling plans for testing and inspection
• Initiate improvements in non-medical manufacturing procedures for best practices and increased compliance

3.

Quality Management / Continuous Improvement (10%)

• Support Quality Management System conformance to customer, internal, ISO 13485, and any other applicable regulatory/legal requirements
• Identify and lead efforts for system improvement, increasing compliance and system effectiveness
• Push completion of Quality action items across the organization, helping employees when necessary
• Support the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s services
• Attend and assist in Management Review meetings, including collection and analysis of data presented
• Assist in complaint management and CAPAs management

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 development 
• 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:  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.