Join a high-growth manufacturing company active in multiple market areas as a Quality Systems Specialist in Logan, UT. This role supports the creation, development, management, maintenance, control, and improvement of the Quality Management System and its corresponding processes, procedures, work instructions, and records.
Responsibilities: • Quality Management System Support
-Performs investigative research and trend analysis of complaints, discrepant material, process control variations, and other quality related issues to understand and identify areas for improvement.
-Compiles information and uses various improvement tools (Lean, Six Sigma, etc.) and statistical techniques to assess and determine root cause of problems.
-Initiates corrective or preventive action and solicits approval through the CAPA process for all proposed actions.
-Conducts internal audits according to the internal audit schedule or as assigned.
-Prepares audit checklists, conducts interviews, and records observations, opportunities for improvement, and audit nonconformities in a formal Audit Report.
-Follows up and clears down all audit nonconformities in future internal audits.
-Participates in External Audits as assigned. • Quality Training
-Consistently provides quality training to individuals -throughout the company.
-Provides role model behavior regarding adherence to process and procedure. • Process Control and Quality Improvement
-Reviews quality and operational processes including manufacturing and QC to ensure processes are adequately controlled.
-Prepares appropriate quality control points throughout the facility to provide evidence that processes are in control.
-Works with department supervisors to identify opportunities for improvement.
-Implements improvements that reduce variation and improve overall quality. • Document Control and Record Control
-Supports the document control team as assigned.
-Establishes and maintains records of all actions according to established process and procedure. • Design Quality Engineering
-Provide guidance, support, and approval during the design and development stages of products.
-Ensure, through coordination with Manufacturing Engineering, new and existing products are manufacturable. Assists in Design Transfer activities.
-Ensures compliance to internal and external requirements throughout the design control process.
-Perform process risk assessments for existing and new products. • Supplier Quality
-Assists in evaluating and monitoring suppliers.
-Supplier audits.
-Provides data analysis to support supplier qualifications.
Requirements: • Bachelor's degree (B.S.) degree in Life Science or Engineering discipline. (Preferred) • 5+ years of direct Quality or Regulatory related experience in the medical device industry (Required) • 3+ yrs of experience with ISO 13485 and FDA 21 CFR 820 quality systems in managing or improving quality processes in a medical device manufacturing environment (Required) • Experience with Design Transfer involving transferring a meticulously designed device from the research and development (R&D) environment to production and commercialization (Required) • Knowledge or experience with quality planning, corrective/preventive action (CAPA) systems, and root cause analysis. Certified and/or experienced Quality Engineers (Preferred). • Knowledge or experience of MDSAP and EU MDR regulations. (Preferred). • Experience interfacing with all levels of the organization, management and staff, and with customers and suppliers; confidentiality is important to this job position. (Preferred) • Knowledge or experience with eQMS software within a medical device industry (Preferred)