Why Work Here?
“A Leader In Portable X-Ray Machines and OEM SourceBlocks”
Overall management of the Quality Inspection and Assurance functions. Review Quality Assurance Procedures (QAPs) and develop new procedures as necessary. Resolve complex quality issues, evaluate product and processes to ensure product quality is not compromised. Work under minimal supervision.
- Oversee Quality Inspection from Incoming to Final.
- Maintain / enhance the ISO 13485 Quality System, develop procedures and forms, perform failure analysis, product dispositions, resolve quality issues and develop corrective actions.
- Provides support for existing products; disposition of non-conforming material, work with suppliers, evaluate customer complaints.
- Analyze problems and monitor processes.
- Perform Internal Quality Audits, as well as in-process and supplier audits.
- Initiate product recalls if necessary, lead Quality meetings.
Education & Work Experience:
- Bachelor’s Degree in a technical field from an accredited college or university required.
- Candidate must have at least 3 to 7 years of Regulatory management experience in the medical device industry, with demonstrated increasing expertise and responsibility.
- Must have a solid understanding of ISO 13485 and FDA regulations.
- Certified Quality Auditor (CQA)
- Good working knowledge of Risk Analysis (ISO 14971).
- Familiarity with regulatory submissions, including 510(k) and initial reports.
- Able to handle multiple projects and exercise good judgment in prioritizing tasks.
- Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
- Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
- High level of attention to detail, and proficient with Microsoft Office applications.
Full-Time, Benefits, 401K, Profit Sharing, EOE
50 Fleetwood Court, Ronkonkoma, NY 11779
3 months ago