Quality Manager 1

Ingersoll-Rand; Lincolnshire (IL); On-site; USD 100,000 - 150,000; Full time

Job summary

Ingersoll Rand is seeking a Quality Manager to lead the site's Quality Management System and ensure product quality aligns with regulatory standards. You will oversee QA, QC, and compliance across departments, driving improvements and ensuring robust documentation and CAPA processes.

The role requires extensive experience in quality assurance within highly regulated environments, ISO 13485 and FDA compliance familiarity, and a proven track record of leading diverse QA/QC teams onsite in

Qualifications

• 8+ years in quality assurance and quality control
• 1+ years leading a large QA/QC team
• 1+ years in medical device, pharmaceutical or highly regulated environments
• 1+ years experience with ISO 13485, FDA 21CFR820, and Good Manufacturing Practices

Responsibilities

• Develops, maintains and executes quality procedures to inspect and report quality issues
• Oversees maintenance of the ISO quality system requirements and monitors effectiveness
• Manages the QMS to ensure regulatory compliance
• Leads QA/QC team hiring, training, coaching, and performance management
• Understands customer needs to develop effective quality control processes
• Hosts customer and regulatory audits and coordinates internal supplier audits
• Leads CAPAs, Non-Conforming Reports, and customer complaint investigations
• Ensures documentation control and revision control across processes
• Ensures products conform to validated processes and Device Master Records and performs lot release
• Monitors calibration and preventive maintenance program for compliance
• Collaborates with purchasing and supervises supplier approval and evaluation
• Manages supplier scorecards and rating systems
• Ensures SOPs and process documentation meet QMS requirements
• Fosters a culture of quality and continuous improvement
• Upholds Ingersoll Rand values

Skills

Quality management

Auditing

Leadership

GxP compliance

Education

Bachelor's degree in quality/engineering

Tools

PPAP

APQP

MSA

CAPA system

Job description

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 Manager

Location

Lincolnshire, IL

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 Manager is responsible for managing and implementing the Quality Management System and processes across the site. This position oversees qualityassurance,and compliance functions and ensures integration throughout departments to ensure the Quality Management System (QMS) is compliant to standards and products meet quality specifications. TheQuality Manager supervises and guides team members following Flexan LLC performance management practices and policies. Assures consistent quality of production by developing and enforcing good systems, validating processes, providing good documentation, and managing staff.

Responsibilities:

• Develops, maintains andexecutesquality procedures to inspect and report quality issues
• Overseesmaintenance of the requirements and monitors the effectiveness of the ISO quality system as well as continually proposing improvements to the system
• Overseethe management of the QMS to ensure compliance with relevant regulatory bodies.
• Accomplishes quality assurance human resource objectives by recruiting, selecting, orienting, training, scheduling, coaching, counseling, and disciplining employees; communicates job expectations and leads team in talent and performance management processes
• Responsible for understanding customer needs and requirements to develop effective quality control processes
• Hosts customer and regulatory audits, as well as coordinates and performs internal quality and supplier audits as needed
• Leads all internal and external CAPAs, Non-Conforming Reports, and customer complaints including investigation, root cause analysis, and other related documentation.
• Ensures all document control and revision control activities are carried out to ensure compliance
• Ensures all products conform to validated processes and Device Master Records, as well as performs lot release and related functions
• Assures the reliability and consistency of production by checking processes and final output
• Provides oversight of calibration and preventive maintenance program to ensure compliance
• Collaborates with purchasing department and co-manages the approved supplier list and evaluates them to ensure product compliance
• Monitors approved supplier list and rates suppliers through score card ratings
• Ensures all SOP’s and process documentation are created in accordance with the QMS and works with all departments to ensure effectiveness
• Provide resources, support, ideas and recommendations to facilitate growth of a “culture of quality”
• Living the IR Values

Requirements:

• Bachelor’s degree or equivalent experience required. A degree in quality, mechanical, or industrial engineering preferred.
• 8+ years minimum overall experience in quality assurance and quality control
• 1+ years of experiencewithin medical device, pharmaceutical or related highly regulated environments required
• 1+ years of experiencesuccessfully leading and managing a large, diverse QA and QC team required
• 1+ years of experiencewith ISO 13485, FDA 21CFR820, and Good Manufacturing Practices required
• 1+ years of experience familiarity with Quality Agreements, PPAP, APGP, and MSArequired

Preferences:

• Certified ISO 13485 Auditor or similar certification preferred
• Experience with hosting notified body and FDA audits preferred
• Excellent verbal and written communication skills with the ability to effectively engage an influence both internal and external stakeholder
• Strong interpersonal skills with the ability to navigate complex situations with professionalism, discretion, and sound judgment
• Proven ability to manage multiple priorities in a fast-paced environment while maintaining attention to detail and delivering high-quality results.

Travel & Work Arrangements/Requirements

• Fully on-site

The pay range for this role is $100,000 - $150,000, excluding incentive opportunities. The pay range takes into account a wide range of factors that are considered in making compensation decisions including, but not limited to, skills; experience and training; licensure and certifications; and geographic location. Hired applicant will be eligible to receive (discretionary/nondiscretionary) annual bonuses and incentive compensation.

WhatWe 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,customersand 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 toexpertise,productivityand efficiency. For more information, visit www.IRCO.com.

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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.