Sr. Quality Engineer

About Us

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.

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. The Senior Quality Engineer also collaborates across departments to enhance current manufacturing/quality processes and supports new product introductions. The Senior Quality Engineer is expected to provide guidance and leadership to other members of the quality department, including Document Technicians, Quality Inspectors, and Quality Engineers.

Responsibilities

• Co-manage the New Product Introduction (NPI) process by ensuring compliance with necessary documentation such as checklists, validation protocols, validation reports, statistical analyses, customer specifications, and relevant ISO documents.
• 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, ensuring adherence to customer and regulatory requirements.
• Develop procedures and work instructions to streamline processes in compliance with FDA regulations, ISO standards, and other applicable regulatory requirements.
• Review and approve change requests, ensuring proper evaluation of the impact on product quality, processes, and regulatory compliance.
• 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 Flexan 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, managing the approved supplier list, and other related tasks.
• Manages 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.
• Engage with key stakeholders to promote a culture of quality throughout the organization.

Requirements

• 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.
• 3+ years of experience in process improvement methodologies and technical writing.
• 3+ years of success in leading new product introductions with a focus on quality assurance and compliance throughout the development process.
• Active involvement in FDA and ISO audits, with a strong understanding of regulatory compliance requirements.

Pay

The pay range for this role is $80-$120k, excluding incentive opportunities. Hired applicant will be eligible to receive (discretionary/nondiscretionary) annual bonuses and incentive compensation.

Schedule

Fully on-site