Quality Assurance Engineer
HWSTAFFING Cranston, RI 02910
- Lead product quality investigations to a successful conclusion.
- Execute risk assessments,collect supporting information and provide recommendations for management considerations.
- Lead department effort in CAPA investigations and completion .
- Interface with their departments to provide guidance an CAPA completion.
- Provide technical guidance to QA and QC personnel.
- Represents quality interest and concerns on project teams.
- Support manufacturing,new product and regulatory to ensure systems and compliant with all internal and external requirements.
- Ivestigate cause of quality problems identified at incoming inspection manufacturing and final QC inspection .
- Collect, analyze,trend and communicate quality data throughout the organizations.
- Identify and help facilitate continuous improvement ,corrective and preventive actions.
- Resource in engineering Change Order review process.
- Mentoring education and training of QC personnel.
- Assume additional responsibilities as necessary at the discretion of QA management.
- Develop programs and mythologies for analyzing and presenting quality system data.
- Identify program opportunity for improvement and drive procedures updates when required.
- Oversee calibration program.
- Adhere to ensure compliance with quality system SOP's,work instructions,drawings good manufacturing practices (GMO),ISO,and FDA requirements.
- Four year degree, preferably in a technical discipline.
- 3-5 years related experience in regulated environment, preferably medical device.
- Proficiency with MS Office.
- Familiarity with use of mechanical and electrical test equipment.
- Knowledge of commonly use concepts ,practices and procedures related to medical device manufacturing.
- Ability to analyze and aggregate data using statistics.
- Experience preferred with ISO 13485, ISO 14971 and FDA QSR for medical devices.
HW Staffing Solutions provides job seekers nationwide great direct hire, temporary and temporary to hire job opportunities with great employers. Find jobs in accounting & finance, office & administrative, light industrial, professional/technical, call center and food processing. Get personal attention, unrivaled benefits and a chance to grow your career.