Quality Manager

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.

Quality Manager

Lincolnshire, IL

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  and join us to own your future.

The Quality Manager is responsible for managing and implementing the Quality Management System and processes across the site. This position oversees quality assurance, and compliance functions and ensures integration throughout departments to ensure the Quality Management System (QMS) is compliant to standards and products meet quality specifications. The Quality 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.

• Develops, maintains and executes quality procedures to inspect and report quality issues
• Oversees maintenance of the requirements and monitors the effectiveness of the ISO quality system as well as continually proposing improvements to the system
• Oversee the 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

• 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 experience within medical device, pharmaceutical or related highly regulated environments required
• 1+ years of experience successfully leading and managing a large, diverse QA and QC team required
• 1+ years of experience with ISO 13485, FDA 21
  
  CFR
  820, and Good Manufacturing Practices required
• 1+ years of experience familiarity with Quality Agreements, PPAP, APGP, and MSA required

• 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…