Quality Control Lead

Ingersoll Rand is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Job title:
Quality Control Lead
Location:
Flexan, Salt Lake City, Utah - onsite

About Us

Imagine a company with technology leadership of over 160 years, yet it operates with the energy of a startup. Ingersoll Rand has dedicated itself to Making Life Better for its employees, customers, shareholders, and planets. We produce innovative and mission-critical flow creation and life science technologies - from compressors to precision handling of liquids, gasses, and powers - to increase industrial productivity, efficiency, and sustainability. Supported by over 80+ brands, our products are used in various end-markets including life sciences, food and beverage, clean energy, industrial manufacturing, infrastructure, and more. Across the globe, we're driving growth with an entrepreneurial spirit and ownership mindset. Learn more at irco.com and join us to own your future.

Job Overview

The Quality Control Lead oversees inspection activities to ensure compliance with regulatory requirements, internal quality standards, customer specifications, and the company's quality management system. Reporting to the Site Quality Manager, this role coordinates daily inspector schedules and workflow, supports outgoing material and product inspections, mentors inspectors, and partners with management, internal departments, and customers on quality matters. Strong working knowledge of ISO 13485 and the FDA quality system requirements referenced in 21 CFR 820 is expected.

Responsibilities

* Coordinate daily schedules, assignments, inspection workflow, and shipment priorities for Quality Inspectors; lead visual and dimensional inspection, quality testing, and Device History Record (DHR) review.
* Review and approve inspection records, nonconformance reports, and related documentation; maintain quarantine locations and ensure proper disposition of parts and materials.
* Train and mentor inspectors through onboarding and on-the-job instruction; participate in inspector interviews and provide the Quality Manager with objective feedback on development, training, and performance.
* Partner with manufacturing, engineering, logistics, purchasing, maintenance, and QC to support the quality assurance program; assist internal and external audits with inspection documentation and evidence of compliance.
* Support root cause investigations, nonconformance reports, corrective and preventive actions (CAPAs), risk management, process failure mode and effects analysis (pFMEA), and Control Plans.
* Assist in developing dimensional and quality control process sheets and work instructions; partner with Engineering on vision system measurement teaching files, and lead Gage R&R studies and other QC validation activities.
* Follow cleanroom, gowning, contamination control, traceability, line clearance, process control, safety, housekeeping, and 5S procedures; meet Flexan standards for quality, cleanliness, and productivity.
* Accurately enter daily ERP data, including time, work orders, operations, indirect work, quantities produced, and deviations; identify improvements to inspection methods, defect reduction, productivity, and waste reduction.

Requirements

* Experience in quality inspection within a medical device manufacturing environment.
* Strong knowledge of ISO 13485 and the FDA quality system requirements referenced in 21 CFR 820, with the ability to support compliance with established QMS processes.
* Ability to analyze information and data to identify product or compliance risks and support management decisions.
* Strong computer skills and familiarity with Microsoft Windows applications.
* Ability to work in a cleanroom and follow gowning requirements, including hair covering and appropriate personal protective equipment.
* Ability to meet the role's physical demands, with or without reasonable accommodation: frequently lift or move up to 25 pounds and occasionally up to 50 pounds; occasionally sit, climb, balance, stoop, kneel, crouch, or crawl.

Core Competencies

* Clear written and verbal communication; professional interactions with coworkers, managers, customers, and all levels of the organization.
* Leadership of employees who may not be direct reports; effective organization, goal setting, prioritization, follow-up, multitasking, and attention to detail.
* Reliable attendance, teamwork, respectful communication, and follow-through; recognize strong performance and address or report safety, performance, interpersonal, and equipment concerns promptly.
* Ownership, integrity, humility, customer focus, and commitment to inspired teams; proactively identify opportunities to improve quality, productivity, waste reduction, and morale.

Travel and Work Arrangements Requirements

Fully onsite at Flexan in Salt Lake City, Utah. First shift, Monday-Friday, 7:00 a.m.-3:30 p.m. Mountain Time, with overtime as needed. This is a non-exempt position at a non-union site. The work environment includes cleanroom operations and occasional exposure to moving mechanical parts.

What We Offer

At Ingersoll Rand, we embrace a culture of personal ownership - taking responsibility for our company, our communities, and our environment, as well as our individual health and well-being. Our comprehensive benefits package is designed to empower you with the tools and support necessary to take charge of your health, ensuring that together, we can continue to make life better. Our range of benefits includes health care options like medical and prescription plans, dental and vision coverage, as well as wellness programs. Additionally, we provide life insurance, a robust 401(k) plan, paid time off, and even an employee stock grant, among other offerings. These benefits are our commitment to you, so you can be your best at work and beyond.

Ingersoll Rand Inc. (NYSE:IR), driven by an entrepreneurial spirit and ownership mindset, is dedicated to helping make life better for our employees, customers and communities. Customers lean on us for our technology-driven excellence in mission-critical flow creation and industrial solutions across 40+ respected brands where our products and services excel in the most complex and harsh conditions. Our employees develop customers for life through their daily commitment to expertise, productivity and efficiency. For more information, visit www.IRCO.com.