AuST Manufacturing is a rapidly-growing medical device design house and manufacturing facility, with an innovative and energetic team that is committed to providing high-quality products to our customers and patients. We are seeking a Quality Systems Engineer that will be instrumental in applying best practices to ensure that QMS systems, CAPA, NCR, Risk Management, Quality Plans, Complaint Management and Deviations are executed properly and functioning at all levels.

Quality System Integration: Ensure QMS requirements are embedded in all manufacturing and product lifecycle activities, including design control, production, and post-market surveillance, in compliance with ISO 13485, FDA 21 CFR Part 820, and applicable regulatory standards.

• CAPA & Nonconformance Management: Lead and support timely investigation, root cause analysis, and closure of Corrective and Preventive Actions (CAPAs) and Nonconformance Reports (NCRs), ensuring effective containment, corrective actions, and documented verification of effectiveness.
• Risk Management: Execute and maintain risk management processes per ISO 14971, including hazard analyses, DFMEA, PFMEA, and risk control measures, ensuring risk files remain current throughout the product lifecycle.
• Planned Deviations & Quality Plans: Review, approve, and monitor planned deviations and quality plans to ensure they are justified, risk-assessed, time-bound, and in compliance with internal procedures and regulatory expectations.
• Change Control: Participate in and evaluate design and process changes for impact to product, regulatory compliance, and documentation (e.g., DHF, DMR, DHR), ensuring all changes are properly reviewed, risk-assessed, verified/validated, and approved per change control procedures.
• Documentation & Record Control: Ensure accuracy, completeness, and compliance of quality records, including inspection data, test reports, risk files, CAPA documentation, and audit records, in alignment with document control requirements.
• Audit & Inspection Support: Act as a QMS subject matter expert during internal, external, and regulatory audits, providing evidence of compliance and supporting continuous audit readiness.
• Quality Planning & Continuous Improvement: Develop and implement quality plans, process controls, and metrics to drive continuous improvement in quality performance, reduce nonconformances, and strengthen regulatory compliance
• Leadership and mentoring responsibility for promoting and implementing best in class Quality Management Systems, manufacturing processes, statistical techniques, and QMS software solutions

Qualifications

• Bachelor’s degree in a scientific or engineering field is preferred.
• Minimum 3 years’ experience, 5 years without a degree, in a quality engineering role in the medical device industry, or a related industry with manufacturing & assembly processes.
• Excellent written and verbal communication skills.
• Proficiency with standard office productivity suite and data analysis software, LMS and eQMS software familiarity is a plus.
• ASQ CQE preferred
• High level of competence in statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation, regression, analysis of variance, probability, etc.
• Experience in medical device design control, risk management, validation, and product lifecycle
• Experience with FDA GMP practices, CAPA and non-conforming material processes
• Working knowledge and application of device regulations, including 21 CFR 820, ISO 13485, and ISO 14971. Knowledge of MDSAP, EU MDD/MDR a plus.
• Ability to manage multiple projects within various disciplines, in a fast-paced environment.
• Self-motivated and capable of working cross-functionally with minimal supervision.
• Demonstrated ability to assess and provide technical, statistical, and quality guidance throughout the organization to ensure high quality, compliant products.
• Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills

Quality System Integration: Ensure QMS requirements are embedded in all manufacturing and product lifecycle activities, including design control, production, and post-market surveillance, in compliance with ISO 13485, FDA 21 CFR Part 820, and applicable regulatory standards.

• CAPA & Nonconformance Management: Lead and support timely investigation, root cause analysis, and closure of Corrective and Preventive Actions (CAPAs) and Nonconformance Reports (NCRs), ensuring effective containment, corrective actions, and documented verification of effectiveness.
• Risk Management: Execute and maintain risk management processes per ISO 14971, including hazard analyses, DFMEA, PFMEA, and risk control measures, ensuring risk files remain current throughout the product lifecycle.
• Planned Deviations & Quality Plans: Review, approve, and monitor planned deviations and quality plans to ensure they are justified, risk-assessed, time-bound, and in compliance with internal procedures and regulatory expectations.
• Change Control: Participate in and evaluate design and process changes for impact to product, regulatory compliance, and documentation (e.g., DHF, DMR, DHR), ensuring all changes are properly reviewed, risk-assessed, verified/validated, and approved per change control procedures.
• Documentation & Record Control: Ensure accuracy, completeness, and compliance of quality records, including inspection data, test reports, risk files, CAPA documentation, and audit records, in alignment with document control requirements.
• Audit & Inspection Support: Act as a QMS subject matter expert during internal, external, and regulatory audits, providing evidence of compliance and supporting continuous audit readiness.
• Quality Planning & Continuous Improvement: Develop and implement quality plans, process controls, and metrics to drive continuous improvement in quality performance, reduce nonconformances, and strengthen regulatory compliance
• Leadership and mentoring responsibility for promoting and implementing best in class Quality Management Systems, manufacturing processes, statistical techniques, and QMS software solutions.

Qualifications

• Bachelor’s degree in a scientific or engineering field is preferred.
• Minimum 3 years’ experience, 5 years without a degree, in a quality engineering role in the medical device industry, or a related industry with manufacturing & assembly processes.
• Excellent written and verbal communication skills.
• Proficiency with standard office productivity suite and data analysis software, LMS and eQMS software familiarity is a plus.
• ASQ CQE preferred
• High level of competence in statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation, regression, analysis of variance, probability, etc.
• Experience in medical device design control, risk management, validation, and product lifecycle
• Experience with FDA GMP practices, CAPA and non-conforming material processes
• Working knowledge and application of device regulations, including 21 CFR 820, ISO 13485, and ISO 14971. Knowledge of MDSAP, EU MDD/MDR a plus.
• Ability to manage multiple projects within various disciplines, in a fast-paced environment.
• Self-motivated and capable of working cross-functionally with minimal supervision.
• Demonstrated ability to assess and provide technical, statistical, and quality guidance throughout the organization to ensure high quality, compliant products.
• Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Ability to Commute:

• Salt Lake City, UT 84119 (Preferred)

Ability to Relocate:

• Salt Lake City, UT 84119: Relocate before starting work (Preferred)

Work Location: In perso