Quality Assurance EngineerThe Metrix Company, Dubuque, IA
The Metrix Company is a FDA registered manufacturer with a Class 100,000 clean room environment. Our standards meet all federal regulations, and we maintain totally controlled manufacturing conditions.
Our product line includes bags, blood transfusion filters, drug and fluid delivery products, IV sets and disposable ambulatory infusion devices. Metrix is also the owner and manufacturer of the Secure (TM) product line, which consists of Total Parenteral Nutrition (TPN) products and the Medflo II(TM) Ambulatory Infusion Device.
QUALITY ASSURANCE ENGINEER
The Metrix Company, a medical device manufacturer, is seeking a full-time Quality Assurance Engineer. This position is responsible for maintaining the company’s quality system and assisting in the review of procedures which support regulatory compliance. The QA Engineer will work closely with the QA Manager, analyzing manufacturing processes for improvement using various methods of testing and problem solving. Assists in maintaining regulatory compliance as new or revised versions of standards are released, serves as the technical expert to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
Other duties include, but are not limited to:
- Supports and provides the regulatory expertise for sustaining efforts and design development projects for the domestic and international markets for medical devices. Prepares and submits registrations, licensing, submission files, 510(k), and other product submissions according to regulatory requirements. Maintains regulatory files for product compliance.
- Assists in process verification and validation
- Makes recommendation based on corrective action investigations or quality issues.
- Reviews customer complaints and develop root cause corrective responses to include tracking and trending
- Develops, executes, and analyzes quality reporting measures
- Assists in maintaining processes and documentation related to sterilization and clean room requirements
- Assists in the development, training and execution of internal audits
- Conducts or participates in supplier quality audits
- Develops an understanding of ISO 13485 and FDA 32 CFR 820 regulations, Canadian Medical Device regulations SDR/98-282 (CMDCAS), sterilization techniques, and cleanroom standards
- Supports quality standards, inspection processes, test methodology, quality plans, calibration methods, and reports.
Qualified candidates must possess a bachelor degree in Biomedical, Mechanical or Industrial Engineering/Technology or related field, with 3-5 years of experience. Regulatory experience preferred. Strong communication skills and computer proficiencies necessary including Microsoft Word, Excel, Access and Outlook.
The Metrix Company offers a comprehensive benefit package, including a 401(k) and profit sharing plan, health, dental, life and disability insurance.
Please send resume and salary requirements to:
The Metrix Company
Attn: Human Resources Manager
4400 Chavenelle Rd.
Dubuque, IA 52002
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