Quality Engineer (Medical Devices)
Astrix Technology
**Quality Engineer (Medical Devices)**
Engineering
Rahway, NJ, NONE
+ Added - 08/08/2025
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+ **Schedule** : Onsite ~8a-5p M-F
+ **Salary** : $90-100K + 5% annual bonus eligibility
Our client, a global leader in the medical technology industry, is looking for a experienced Quality Engineer to join their growing team. This is a great opportunity to work with a company that provides specialty medical technology solutions for some of the worlds most complex medical devices.
**ESSENTIAL DUTIES AND RESPONSIBILITIES:**
+ Reviews and thoroughly understands product functional and design specifications.
+ Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
+ Designs or specifies inspection plans, testing mechanisms and equipment.
+ Conducts quality assurance tests.
+ Performs statistical analysis to assess the cost of, and determine the responsibility for, products or materials that do not meet required standards and specifications.
+ Performs defect analysis utilizing experience in statistical quality process analytical methods.
+ Prepares and maintains a variety of reports; manages documentation control systems.
+ Reviews returned material and verifies customer complaints; develops action plan to address discrepancies; communicates with customers as required.
+ Communicates and resolves QA issues with operators/technicians on a day-to-day basis.
+ Prioritizes and manages multiple projects within design specifications and budget restrictions.
+ Investigates and thoroughly understands developments in quality assurance codes and standards.
+ Anager in the maintenance of the quality management system in compliance with appropriate regulatory requirements, customer requirements, and international standards.
+ Creates programs and tooling for automated measurement system
+ Performs other related duties as assigned by management.
**COMPETENCIES:**
+ **Analytical** : Synthesizes complex or diverse information. Collects and researches data. Uses intuition and experience to compliment data. Designs workflows and procedures.
+ **Project Management** : Develops project plans. Coordinates projects. Communicates changes and progress. Completes projects on time and budget. Manages project team activities.
+ **Planning/Organizing** : Prioritizes and plans work activities. Leads project teams to address production or customer issues. Use time efficiently. Plans for additional resources. Sets goals and objectives. Organizes or schedules other people and their tasks. Develops realistic action plans.
+ **Quality** : Demonstrates accuracy and thoroughness. Looks for ways to improve and promote quality. Applies feedback to improve performance. Monitors own work to ensure quality.
+ **Adaptability** : Adapts to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
+ **Innovation** : Displays original thinking and creativity. Meets challenges with resourcefulness. Generates suggestions for improving work. Develops innovative approaches and ideas. Presents ideas and information in a manner that gets others’ attention.
**QUALIFICATIONS:**
+ Bachelor’s Degree (B.S.) in a related field.
+ 2-4 years related experience.
+ Commitment to excellence and high standards.
+ Excellent written and oral communication skills.
+ Strong organizational, problem-solving, and analytical skills.
+ Ability to manage priorities and workflow.
+ Acute attention to detail.
+ Demonstrated ability to plan and organize projects.
+ Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.
+ Working knowledge of Quality tools (eg. Gage R&R, SPC, Root Cause Analysis)
_This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_
_INDBH_
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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