Sr. 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 Title: Sr Quality Engineer
Location: Salt Lake City, UT

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.

Job Overview:
The Senior Quality Engineer is responsible for ensuring compliance with Quality Management System (QMS) and applicable regulatory requirements within our medical device manufacturing environment. This role encompasses a wide range of responsibilities, including validation activities, process improvements, nonconformance and CAPA management, auditing responsibilities, risk assessments, and training initiatives.

• Co-manage the New Product Introduction (NPI) process by ensuring compliance with necessary documentation.
• Assist engineering teams with sustaining manufacturing projects by ensuring compliance with change control, tool and equipment maintenance, and revalidation procedures.
• Review and approve engineering documentation, including validation protocols/reports, sample run requests, and manufacturing procedures.
• Develop procedures and work instructions to streamline processes in compliance with FDA regulations, ISO standards, and other applicable regulatory requirements.
• Lead the resolution of internal and external nonconformances by performing root cause analysis and implementing corrective and preventive actions.
• Oversee the investigation of product complaints, ensuring timely resolution and appropriate reporting.
• Represent the company effectively during customer and supplier meetings.
• Complete customer surveys and requests in a timely manner.
• Contribute to the Supplier Management Program by assessing new and existing suppliers.
• Manage change requests submitted to customers through completion.
• Provide expertise on environmental and cleanroom requirements, ensuring compliance with relevant guidelines.
• Evaluate new technologies and tools for potential integration into processes to enhance efficiency.
• Monitor key quality metrics and provide regular reports to management.
• Lead risk management activities by conducting risk assessments and pFMEAs sessions, as required.
• Collaborate with cross-functional teams to identify equipment, testing, and resource needs, effectively communicating these to management.
• Host or co-host customer and ISO audits, as well as FDA inspections, ensuring preparedness and compliance.
• Serve as a backup for various quality functions, including Document Technicians and Quality Engineers, as needed.
• Support the Quality Manager in the overall maintenance and monitoring of the Quality Management System (QMS).
• Lead initiatives to improve the Quality Management System and participate in the periodic review of documents.
• Conduct employee training sessions.
• Perform internal and external audits as assigned.
• Assist other business units with projects as assigned.
• Able to perform state/international travel as needed.
• Engage with key stakeholders to promote a culture of quality throughout the organization.

• 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.
• 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.

• 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.