Sr. Quality Engineer
- Salt Lake City, UT
- Permanent
- Full-time
Location: Salt Lake City, UTAbout 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 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.
Able to perform state/international travel as needed.
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.
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 (respectful of supervisors and co-workers, helps others by offering ideas when appropriate)
Follows through on tasks and projects as assignedPreferences:
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 listsCore Competencies:
Quality
Accountability
Respect
Innovation
Integrity
Open & honest communications
Teamwork
Customer focusTravel & Work Arrangements/Requirements:
OnsiteWhat 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.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.To Apply:
Please apply via our website https://ir-jobs.dzconnex.com/ by October 24th in order to be considered for this position.