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Quality Assurance Engineering Technician
2 months ago
CoWorx Staffing Services is seeking a Quality Assurance Engineering Technician for a leading medical manufacturing organization. This role is a permanent position on the first shift, providing an opportunity to work with a top-tier employer.
PRIMARY OBJECTIVE OF THE ROLE:
The Quality Assurance Engineering Technician plays a crucial role in the formulation and execution of policies and procedures aimed at testing and assessing the precision and reliability of products and equipment. This position will involve collaboration with Operations, customer interaction, and support for Engineering, Quality Systems, and Process Engineering. The technician will be essential in fulfilling the requirements of the Quality Management System, necessitating creativity and foresight to work alongside operations and product development teams to ensure adherence to the Quality Manual, Design Control, Supplier Management, and other relevant procedures for various medical devices.
KEY RESPONSIBILITIES:
- Ensure compliance with FDA Quality System Regulations and ISO 13485 standards.
- Participate actively in internal audits, with a readiness to train and/or achieve Lead certification.
- Provide production support through Quality Engineering (Technician Level) guidance for Nonconformance, Change Control, and Release Activities.
- Assist with customer-related quality and regulatory inquiries.
- Engage in and support continuous improvement initiatives.
- Contribute to the development and implementation of standard methods for inspection, testing, and evaluation, leveraging knowledge in related engineering disciplines.
- Facilitate measurement system analyses under Engineering Direction to assess testing and inspection equipment.
- Support the resolution of discrepancies in materials and develop processes to evaluate product quality and reliability under Quality Engineering Direction.
- Assist with FDA and ISO inspections, audits, and registrations.
- Participate in activities aimed at enhancing the ratio of value-added to non-value-added processes.
- Exhibit a willingness to learn and adapt under Engineering Direction through mentorship and responsiveness to business needs to achieve favorable outcomes.
- Demonstrate foundational technical skills through the application of Engineering Technician competencies and knowledge.
Qualifications:
- High School Diploma or equivalent.
- Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
- Solid experience with quality systems documentation.
- Strong organizational skills with a proven ability to manage multiple tasks simultaneously.
- Comprehensive understanding of FDA CFR 820 and ISO 13485.
Experience Requirements:
- A minimum of 5 years of quality experience in a manufacturing setting is required.
CoWorx is dedicated to the individuals we serve, helping job seekers build rewarding careers while partnering with clients to develop world-class, strategically optimized workforces.
Our commitment to the professional growth of job seekers enhances their impactful contributions to employers. Our experienced team places candidates in various roles, including administrative, light industrial, call center, distribution, and third-party logistics, with additional opportunities in executive search, creative staffing, and luxury beauty and fragrance sectors.
As one of the largest staffing firms in the U.S., CoWorx is a trusted partner for businesses seeking temporary staffing, direct hire, on-site services, and payrolling solutions. We continuously invest in our teams and processes, raising the standards of client partnership, diversity, equity, and inclusion commitment, and community impact within the staffing industry.
