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Aptyx · 1 day ago

Quality Engineer (MED DEVICE)

740 W Knox Rd, Tempe, AZ, USA

Full-time

Onsite

Mid, Senior Level

3+ years exp

Aptyx is a company focused on medical device manufacturing, and they are seeking a Quality Engineer to oversee and ensure the quality of products and processes. The role involves implementing quality assurance practices, ensuring regulatory compliance, and driving continuous improvement initiatives.

ManufacturingPlastics and Rubber Manufacturing

Responsibilities

Develop, implement, and maintain quality assurance policies and procedures to ensure product quality and compliance

Create and maintain Quality Assurance documentation including Control Plans, pFMEAs, Quality Alerts, and Inspection Plans

Conduct Process Validations for new and revised products and processes ensuring long term capability

Monitor production processes to ensure consistent product quality

Collect and analyze data on product quality and process performance

Conduct audits of raw materials, in-process products, and finished goods to verify adherence to quality standards

Measure parts using hand gages, CMM, Video Measurement System

Ability to interpret part prints. Utilize GD&T when applicable

Ensure that all products and processes comply with relevant medical device regulations and standards, such as ISO 13485 and FDA requirements

Prepare and manage documentation for regulatory submissions and audits

Lead root cause analysis and corrective action activities for non-conforming products

Collaborate with production, engineering, and R&D teams to implement effective corrective and preventive actions

Address customer complaints and quality concerns including processing of Return Material Authorization, RMA, and formal Corrective Actions

Support customer audits and visits by providing necessary documentation and information

Support and provide routine status updates to Customers regarding open actions including, but not limited to, Corrective Actions, Projects, and/or other Status Updates

Active participant in Drawing Reviews to ensure that Quality Requirements can be satisfied

Support Quality requirements for New Product Introduction working closely with Program Managers to support critical timelines for completion

Drive continuous improvement initiatives aimed at enhancing product quality, reducing waste, and improving efficiency. Provide review of any changes for impact on QMS

Identify areas for process improvement and lead initiatives to enhance product quality and manufacturing efficiency

Participate in and lead cross-functional quality improvement teams

Mentor and train quality control personnel and junior quality engineers

Conduct quality-related training programs for manufacturing and other relevant staff

Conduct internal audits to ensure compliance with quality management systems and regulatory requirements

Prepare for and support external audits by regulatory bodies and customers

Qualification

Quality AssuranceInjection MoldingISO 13485CMM MeasurementStatistical AnalysisCertified Quality EngineerProblem-Solving SkillsAttention to DetailCommunication SkillsLeadership Skills

Required

Bachelor's degree in Engineering, preferably in Mechanical, Industrial, or Plastics Engineering

Minimum of 3-5 years of experience in a quality role within the medical device manufacturing industry, with significant experience in plastic injection molding

In-depth understanding of quality assurance principles and methodologies

Extensive knowledge of injection molding processes and equipment

Familiarity with medical device regulations and standards, including ISO 13485 and FDA requirements

Experience working with CMMs to measure parts

Strong analytical and problem-solving skills

Excellent attention to detail and organizational skills

Proficiency in statistical analysis and quality management software

Effective communication and leadership skills