Quality Assurance Specialist
2 weeks ago
Columbia Tech is a leading provider of Time to Market Services, offering product development, manufacturing, global fulfillment, and aftermarket services to innovation leaders in various industries. As a Quality Assurance Specialist, you will play a critical role in ensuring the highest quality standards are met for our products.
Key Responsibilities:- Lead by example and promote strict compliance adherence at Columbia Tech.
- Assist in training personnel, including customers and suppliers, on workmanship and quality standards.
- Ensure all outgoing products are manufactured in a compliant manner.
- Support process qualification/validation and new product introduction processes.
- Develop and execute Control Plans.
- Review device history records for quality approval as needed.
- Oversee and execute Redline and Engineering Change Notifications (ECNs) processing.
- Suggest improvements to ECN/ECO process for improved efficiency, accuracy, and quality.
- Meet or exceed established ECO implementation performance metrics.
- Drive improvement of Columbia Tech Quality through analyzing non-conformances and performing root cause analysis of discrepancies.
- Collaborate with internal groups and customers to determine root cause of customer issues.
- Support non-conforming material issues resolution with suppliers.
- Lead the Quality Control inspection process.
- Develop skills as a Trainer to new QC Inspection resources.
- Develop quality and inspection plans.
- Assist in developing and executing supplier audit plans.
- Contribute to the ongoing assessment of current and new potential suppliers.
- Support continuous supplier improvement through data collection and statistical analysis.
- Positive attitude, self-motivator, and tenacious follow-up required.
- Superior customer service attitude.
- Excellent teamwork, communication, and interpersonal skills.
- Bachelor's degree, preferably in a science or engineering discipline.
- Strong electro-mechanical orientation.
- Minimum of 2 years professional experience in medical subassembly and finished device manufacturing.
- Proven problem solver.
- Knowledge of IPC 610 and 620 standards beneficial.
- Advanced Level Skills in MS Word and Excel.
Generally works in an office environment, but may occasionally be required to perform job duties outside of the typical office setting.
Columbia Tech is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.
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