Aequor · 1 week ago
Quality Engineer (MED DEVICE)
Tempe, AZ
Full-time
Onsite
Mid Level
3+ years expAequor is a company specializing in medical device manufacturing, seeking a Quality Engineer to oversee product quality and compliance. The role involves implementing quality assurance practices, conducting audits, and driving continuous improvement initiatives within the medical plastic injection molding environment.
ConsultingIT ManagementRecruiting
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
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
Preferred
Some programming experience with CMMs preferred but will train if needed
Certification such as Certified Quality Engineer (CQE) from ASQ is highly desirable
Company
Aequor
Since 1998, Aequor has provided exceptional workforce staffing services in multiple industries.
201-500 employees
H1B Sponsorship
Aequor has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (1)
2022 (3)
2021 (1)
2020 (5)
Funding
Current Stage
Growth StageLeadership Team
Kamalpreet S. Virdi
CEO & Chairman
Recent News
Staffing Industry Analysts
2023-12-24
2023-07-11
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