Quality Assurance Specialist
3 weeks ago
We are seeking a highly motivated and detail-oriented Quality Inspector to join our team at our New Hampshire facility in Somersworth. As a Quality Inspector, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.
Key Responsibilities:- Generate certificates of compliance and conduct inspections and testing to ensure product quality
- Review Device History Records (DHRs) and ensure compliance with regulatory requirements
- Communicate test data results and findings to relevant stakeholders
- Maintain compliance with US FDA regulations and ISO 13485 Quality Management System standards
- Work with manufacturing and engineering personnel to test and inspect components and materials
- Provide test and inspection support to new process developments
- Review lab results and approve product release
- High school degree or GED equivalent required
- 2 years of experience in a medical device manufacturing or pharmaceutical environment, or 5 years' experience in a general manufacturing environment
- Knowledgeable in applications of caliper use, calibration and verification of tools, basic math skills and blueprints/drawings comprehension, IQ/OQ/PQ and quality principals
- Basic knowledge of Good Manufacturing Practice and Quality Management Systems applicable to the medical device industry
- Proficient in Microsoft Office Suite skills including electronic mail, record keeping, routine database activity, word processing, spreadsheets, graphics, etc.
- Attention to detail in a fast-paced environment
- Ability to work independently and take initiative
- Good interpersonal, communication (both verbal and written) skills
- Strong verbal and written communication skills
- Excellent organizational skills with the ability to handle multiple projects
- Passion for customer service and business growth
- Displays courtesy, tact and patience during interactions with all employees and customers
- Confident and creative
- Acts in an ethical manner at all times and demands the same in others
- Experience in process troubleshooting and timely resolution of issues
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Individual will need to sit (at times for extended periods) or stand as needed. May require walking primarily on a level surface during the workday. Reaching above shoulder heights, below the waist or lifting as required to file documents or store materials during the workday.
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