Sr. Quality Engineer

Ingersoll Rand-posted 3 months ago
Full-time • Mid Level
Salt Lake City, UT
Machinery Manufacturing
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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.

  • 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.
  • 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 (respectful of supervisors and co-workers, helps others by offering ideas when appropriate).
  • Follows through on tasks and projects as assigned.
  • 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.
  • Health care options like medical and prescription plans.
  • Dental and vision coverage.
  • Wellness programs.
  • Life insurance.
  • Robust 401(k) plan.
  • Paid time off.
  • Employee stock grant.
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