We are seeking a well qualified Quality Assurance Engineer for a growth-based Medical Device company located in NJ. The QA Engineer will manage internal and external quality operations, oversee activities related to development, application, training, and maintenance of quality standards, processes, materials, and products. This full-time, in-house position will report to the Director of Quality.
Our client is an innovative developer and manufacturer of medical devices supporting orthopedic professionals in their quest to alleviate pain and improve the quality of life for patients.
- Work closely with R&D and Operations to develop and implement quality plans and procedures to meet industry, regulatory and internal company standards.
- Develop standards and implement methods for inspection, testing, and evaluation of raw materials, in-process and final products.
- Create SOP’s and documents to record, evaluate, and report quality data.
- Coordinate and support validation activities.
- Evaluate the precision and accuracy of test, measurement, and analytical equipment.
- Responsible for the proper calibration of gauges and test equipment used for monitoring quality.
- Maintain scrap and rework trend analysis data.
- Establish and Maintain waste material programs.
- Interface with suppliers for inspection and quality matters.
- Conduct supplier audits, review supplier quality systems and QC programs.
- AS/BS Degree in a relevant technical or engineering discipline.
- Medical Device industry experience is required for this role.
- 5+ years of quality and product inspection experience within the medical device industry REQUIRED
- Sound understanding of the principles and methods of inspection.
- Knowledge and understanding of geometric dimensioning and tolerance.
- Skilled at the use of measuring instruments such as micrometers, calipers, optical comparators and coordinate measuring machines.
- Ability to interpret engineering drawings Ability to prioritize, multi-task and complete essential responsibilities with minimal oversight.
- Knowledge of FDA 21 CFR 820, and ISO 13485:2016
- Data Analysis, report writing, and business correspondence
- Excellent Communication, Customer Service and documentation skills.
- Knowledge of MS Office (Word, Excel, PowerPoint...) and basic ERP systems.
- Excellent employment references and stable career history.