Sr Manufacturing Quality Engineer (IQ/OQ/PQ) at Infosoft, Inc. Sr Manufacturing Quality Engineer (IQ/OQ/PQ) at Infosoft, Inc. in Riverton, Utah Posted in about 3 hours ago.

Type:

full-time

Job Title:

Sr Manufacturing Quality Engineer (IQ/OQ/PQ)

Pay Rate:

$51 to $64.10/

HR Duration:

7 months

Location:

Draper, UT Shift :

2nd Shift Our Client is a Global medical device Manufacturer. Our client is seeking a Sr. Manufacturing Quality Engineer to support quality and process engineering activities within a regulated medical device manufacturing operation. This position will apply quality engineering, statistical, Lean, and Six Sigma methods to improve manufacturing processes, strengthen validation activities, and reduce product and process risk. The engineer will work hands-on with production, engineering, inspection, suppliers, and other cross-functional teams to resolve complex quality issues and implement sustainable improvements. The ideal candidate brings strong manufacturing Quality Engineering experience and can independently lead technical investigations, validation activities, and process improvement projects. Lead manufacturing quality improvement projects using engineering, Lean, Six Sigma, and statistical problem-solving techniques. Evaluate production processes, equipment, tooling, fixtures, and test methods to identify opportunities for improved quality, capability, and risk reduction. Develop and execute engineering experiments and manufacturing tests, including preparation of protocols, test plans, data analysis, and technical reports. Plan, coordinate, and support process and test-method validation activities, including TMV, IQ, OQ, and PQ . Analyze validation and process data to determine whether manufacturing processes and test methods meet established requirements. Investigate complex production quality problems and determine root causes using structured engineering and problem-solving methodologies. Lead or support resolution of NCRs, nonconformances, CAPAs, SCARs, MRB issues, and audit-related findings . Evaluate manufacturing and product risks and contribute technical content to quality risk-management documentation. Review proposed manufacturing changes and provide technical leadership through the applicable change-control process. Develop and update manufacturing documentation, work instructions, inspection procedures, and training materials. Provide technical direction to quality/manufacturing engineers, technicians, operators, and inspection personnel during testing and improvement activities. Work with suppliers and internal teams to evaluate materials, components, processes, and related quality concerns. Interpret engineering drawings and manufacturing specifications when evaluating product and process requirements. Apply statistical methods and quality engineering principles to monitor, troubleshoot, and improve manufacturing performance. Communicate technical findings, recommendations, validation results, and quality risks to cross-functional stakeholders. Maintain a high level of compliance with applicable quality, environmental health and safety, and controlled manufacturing requirements. Requirements Bachelor's degree in Engineering required. 5-7+ years of relevant Quality Engineering experience , preferably in a medical device or similarly regulated manufacturing environment. Hands-on experience with manufacturing quality engineering, process improvement, and production problem solving . Demonstrated experience with process validation and/or test-method validation , including IQ, OQ, PQ, and TMV . Experience investigating and resolving manufacturing quality issues involving NCRs, nonconformances, CAPA, SCAR, MRB, and/or audit findings . Strong knowledge of statistical quality techniques and the practical application of quality engineering principles. Working knowledge of Six Sigma and Lean manufacturing methodologies with demonstrated application to manufacturing problems. Ability to read and interpret engineering/manufacturing drawings and specifications. Understanding of manufacturing processes, production equipment, tooling, fixtures, and test methods. Strong technical writing and documentation skills, including the ability to prepare protocols, reports, work instructions, and other controlled documentation. Ability to communicate technical information effectively to engineers, technicians, operators, inspectors, suppliers, and other organizational levels. Strong analytical, critical-thinking, root-cause analysis, organizational, and problem-solving skills. Ability to work independently while coordinating effectively with cross-functional teams. Strong leadership and influencing skills, including the ability to guide engineers and technicians through technical work. Proficiency with Microsoft Office applications. Experience working in a cleanroom or controlled medical device manufacturing environment and understanding of applicable Quality and EHS requirements. Six Sigma Green Belt or higher preferred. ASQ Certified Quality Engineer (CQE) preferred. Experience with automation, software testing, and/or software validation is a plus. Must be comfortable managing multiple technical priorities in a fast-paced manufacturing environment and working the assigned 2nd shift.