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Ingersoll Rand · 4 days ago

Sr. Quality Engineer - NPI

Salt Lake City, UT

Full-time

Onsite

Senior Level

5+ years exp

Ingersoll Rand is an equal opportunity employer dedicated to making life better for its employees and customers. The Senior Quality Engineer is responsible for ensuring compliance with Quality Management System (QMS) and regulatory requirements in a medical device manufacturing environment, overseeing validation activities, process improvements, and cross-department collaboration.

Test and Measurement

H1B Sponsor Likely

Responsibilities

Co-manage the New Product Introduction (NPI) and sustaining manufacturing processes by ensuring compliance with required documentation, validations, customer specifications, ISO standards, and regulatory requirements

Review, approve, and manage engineering and change-control documentation, including validation protocols/reports, manufacturing procedures, sample requests, and customer change submissions through completion

Develop, maintain, and improve procedures, work instructions, and QMS documentation in compliance with FDA regulations, ISO standards, and applicable environmental and cleanroom requirements

Lead risk management, nonconformance resolution, and CAPA activities, including root cause analysis, pFMEAs, complaint investigations, and corrective/preventive action implementation

Monitor, analyze, and report key quality metrics, providing regular updates to management and driving continuous improvement initiatives

Support and lead customer, supplier, ISO, and FDA audits and inspections, ensuring audit readiness and effective representation of Flexan

Contribute to the Supplier Management Program, including supplier assessments, approved supplier list maintenance, customer surveys, and supplier/customer engagement

Promote a strong culture of quality by collaborating cross-functionally, delivering employee training, supporting the Quality Manager, and serving as a backup for key quality functions as needed

Qualification

Quality Management System (QMS)FDA regulationsISO standardsFailure Mode Effects Analysis (FMEA)Production Part Approval Process (PPAP)Statistical/data analysisProcess improvement methodologiesSupplier quality managementCoachingDevelopmentTechnical writingTime managementCommunication skillsProblem-solvingTeam player

Required

BA / BS in Engineering or related field

5+ years of Quality Engineering or similar experience in a medical device manufacturing environment and/or regulated industry

Preferred

Robust knowledge of Failure Mode Effects Analysis (FMEA) and Production Part Approval Process (PPAP)

Strong technical writing skills

Experience with supplier quality functions, including management of approved vendor lists

Demonstrated experience in process improvement methodologies

Active involvement in FDA and ISO audits, with a strong understanding of regulatory compliance requirements

Detailed knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14644-1

Strong analytical skills with emphasis on statistical/data analysis

Ability to coach and develop others

Ability to drive/lead in a matrix structure with persuasion and influence

Organization and time management skills are essential

Creativity, verbal and written communication skills, and problem-solving ability

Team player that gets along well with others (respectful of supervisors and co-workers, helps others by offering ideas when appropriate)

Follows through on tasks and projects as assigned

Benefits

Health care options like medical and prescription plans

Dental and vision coverage

Wellness programs

Life insurance

A robust 401(k) plan

Paid time off

Employee stock grant

Company

Ingersoll Rand

Glassdoor3.7

Ingersoll Rand is an industrial manufacturing company that provides mission-critical flow creation and industrial solutions.

Founded in 1871

Davidson, North Carolina, USA

10001+ employees

https://www.irco.com/en-us/

H1B Sponsorship

Ingersoll Rand has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2020 (14)