Quality Engineer

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 Summary:

The PharmBio business quality engineer actively supports on-site pharmaceutical containment manufacturing on a day-to-day basis. The quality engineer would utilize their knowledge of ILC Dover quality systems to drive compliance to ILC Dover, ISO 9001, ISO 13485, and customer standards. As part of these actions, they will identify continuous improvement opportunities and participate in team activities that drives these opportunities to closure. The quality engineer may also participate in customer facing interactions such as audits, and customer complaint responses.

Successful candidates will have cGMP experience in pharmaceutical and/or medical device manufacturing environments, a data driven approach, and a willingness to work together as a team.

Essential Job Responsibilities:

• Design and implement audits and control plans for products to ensure product quality targets are met.
  
  
  
  
  
  
  
• Establish, define, implement, maintain, and report on quality assurance key performance measures and standards.
  
  
  
  
  
  
  
• Investigate non-conformances and consumer complaints, lead completion of root cause analysis, implement corrective actions, and monitor progress and improvements.
  
  
  
  
  
  
  
• Drive continuous improvement on quality standards, requirements, and best practices.
  
  
  
  
  
  
  
• Create and maintain quality systems documentation, such as quality manuals, procedures, and work instructions.
  
  
  
  
  
  
  
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
  
  
  
  
  
  
  
• Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
  
  
  
  
  
  
  
• Prepares and presents technical and program information to team members and management.
  
  
  
  
  
  
  
• Directs technical and administrative workers engaged in quality activities.
  
  
  
  
  
  
  
• Maintains a working knowledge of government and industry quality codes and standards including ISO 9001 and ISO13485.
  
  
  
  
  
  
  

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Basic Qualifications:

• Bachelor of Engineering (BE) or Bachelor of Science in Engineering degree (BSE) or an equivalent number of relevant years of experience.
  
  
  
  
  
  
  
• Assist in driving continuous improvement on quality standards, requirements, and best practices.
  
  
  
  
  
  
  
• Experience in CAPA, root cause analysis and 8D.
  
  
  
  
  
  
  
• Six Sigma Green Belt or Black Belt.
  
  
  
  
  
  
  
• Demonstrates strong analytical, problem-solving skills.
  
  
  
  
  
  
  
• Strong written and verbal communication skills.
  
  
  
  
  
  
  
• Detail oriented, good organizational traits.
  
  
  
  
  
  
  
• Proficient with word processing software; statistical analysis software (SPC); graphics software; order processing software, and database software.
  
  
  
  
  
  
  
• Proficient in using Microsoft Office Suite.
  
  
  
  
  
  
  
• Proficient with precision measurement tools, calibration, and test equipment.
  
  
  
  
  
  
  

Preferred Qualifications:

• Master's degree in engineering or Advanced Degree in a related field of study.
  
  
  
  
  
  
  
• Experience or exposure to the Pharmaceutical/Medical Device Industry with a primary focus on working in a Quality Control / Engineering capacity.
  
  
  
  
  
  
  
• Experience working in a clean room environment and aseptic manufacturing environment.
  
  
  
  
  
  
  
• ISO 13485 Internal auditor.
  
  
  
  
  
  
  
  

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.