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Company

Solmetex, LLC · 3 weeks ago

Quality Engineer

Colorado Springs, CO

Full-time

Onsite

Mid Level

3+ years exp

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Responsibilities

Lead, monitor and ensure compliance with quality standards during production, testing, and distribution of products.

Assist in reviewing and maintaining technical and regulatory documentation, including design controls, risk assessments, validation reports, and traceability matrices, to ensure alignment with applicable regulatory requirements.

Be the on-site quality subject matter expert, integrating with operational and engineering teams to support the deployment of UDI, market label updates, validations, laboratory testing, and other areas needed

Support regulatory compliance by preparing and reviewing quality-related documentation and providing necessary information for regulatory questions.

Lead cross-functional teams in the investigation and root-cause analysis of quality issues, deviations, and CAPAs.

Identify opportunities to enhance product quality, process efficiency, and regulatory compliance within the Quality Management System. Assist in implementing best practices for product lifecycle management.

Collect and analyze quality data to identify trends, monitor product quality, and recommend improvements to prevent defects.

Collaborate with the Quality Technician to ensure seamless execution of quality control activities.

Support the calibration process to ensure all gauges and instruments are calibrated with appropriate records and labels.

Support internal and external audits and inspections by preparing documentation and responding to auditor inquiries.

Provide technical guidance to customer service teams regarding field applications, installation, and addressing quality concerns.

Qualification

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ISO 13485 2016FDA QSMREU MDD/MDRMDSAPEPA FIFRAQuality Control PrinciplesQuality Management SoftwareTechnical Documentation8D RCAFMEAMicrosoft Office SuiteChemical Lab InstrumentsMentoring Skills

Required

Bachelor’s degree in engineering or a related technical field.

Equivalent combinations of education and experience may be considered.

3-5 years of experience in a regulated manufacturing environment, preferably within medical devices, pharmaceuticals, or EPA FIFRA regulated products.

Strong analytical skills with the ability to interpret data and provide actionable insights for quality improvement.

Strong understanding of quality control principles (8D RCA, FMEA, etc.), inspection techniques, and testing methodologies.

Ability to read and interpret technical drawings, engineering specifications, and inspection/test protocols.

Effective verbal and written communication skills to convey quality standards and regulatory requirements across departments.

Ability to measure, record, and interpret results from various chemical lab instruments such as pH probes, TDS meters, graduated cylinders, and other equipment.

High level of attention to detail, particularly when reviewing technical documentation and product specifications.

Demonstrated ability to mentor and provide guidance to junior team members, fostering a collaborative and supportive work environment.

Proficiency with Microsoft Office Suite and quality management software systems.

Preferred

Direct experience with ISO 13485:2016, FDA QSMR, EU MDD/MDR, MDSAP, EPA FIFRA regulations, and their application in a manufacturing environment preferred.

Relevant quality certification from recognized body such as ASQ CQE, CQA, or others desired.