The Quality Engineer is primarily responsible for problem identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventive action for in process, product and equipment related quality issues. This includes responsibility for the quality aspects of qualification and/or validation of molds, products, processes and equipment.
- Coordinates process validations along with the Engineering and Operations teams. As well, applying statistical tools during the different validation phases (IQ/OQ/PQ/PPQ)
- Prior knowledge of medical device regulations such as ISO 13485 or 21 CFR Part 820
- Problem Solving: identification, data collection and trend analysis, reporting, and initiation of corrective and/or preventive action
- Continuous Quality Improvement: systems, documents, software and technical tools
- Support Internal and External Audits
- Monitoring and improvement of SPC systems, sampling plans and statistical methods
- Reporting of internal and external quality problems and trends
- Ability to create Master Validation and Quality Plans for New Product Introduction
- Participate in the Material Review Board along with the different departments
- Cost of Poor Quality reporting and analysis
- Assist Inspectors in Quality Assurance as needed
- Perform other duties as assigned by the Manager Quality Assurance
- Minimum 3 years’ experience in medical device industry or other FDA regulated industry
- Bachelor’s degree in technical field or equivalent working experience
- Excellent oral and written communication skills, ability to communicate with internal/external customers
- Preferred – Demonstrated experience to lead teams and projects. Good organizational skills. Previous experience in plastic injection molding related environment.
- Comprehensive understanding of ISO 9001, ISO 13485, JPAL MHLW Ordinance 169, and/or FDA QSR regulatory requirements
- Desired candidate will have prior work history in MSA, SPC (Infinity QS), Statistical Analysis (Mini-tab), Sterilization, & Clean Room environment.
At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.