VIVA USA Inc Quality Engineer in Walpole, Massachusetts
Req Ref No: MDMAQE271 Location: Walpole, MA Duration: 11.0 months
Are you ready to be part of a dynamic Medical Device Company that delivers quality, compliant, and timely diagnostics testing consumables to customers worldwide? This Quality Professional (QA) position reports to the Sr. Manager of Quality and provides daily support to the cross functional operations at the East Walpole site across business units which include Laboratory Diagnostics & Point of Care Diagnostics. This position primarily manages Quality Document approvals and Quality Notifications. Secondary responsibilities include Batch Release of Reagents for Atellica & Centaur Assays as well as external audit support. In addition to supporting these activities for routine manufacturing, this position will provide support during the launch of a new immunoassay analyzer. Flexibility for working remotely and on site considered.
- Ensure site strategies and procedures are adhered to and in alignment with Global Procedures to ensure compliance with US and International standards applicable to In Vitro diagnostics. Such standards include; 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and European IVDD Directive 98/79/EC.
- Lead Quality Initiatives to drive quality system improvements.
- Foster trust, collaboration and cooperation with manufacturing teams when resolving discrepancies and non-conformance events.
- Support investigations and resolutions of manufacturing issues while ensuring that communication is effective, and information is provided in a timely manner and decisions are compliant.
- Drive the Quality Notification process for product disposition and release.
- Review and approve Device History Records for final QA batch release.
- Manages on site cross functional compliance walk throughs to ensure facility is continuously audit ready; Support Notified Body and Regulatory Audit preparations and provides a key role during on site audits.
- Provide QA review and approval on documents and technical reports to support site Change Control projects.
- Support launch activities for new immunoassay analyzer.
Required Knowledge/Skills, Education, and Experience 1.Requires a proven understanding of external regulations, particularly with regards to 21 CFR Part 820 and ISO 13485. Working knowledge of the IVDD Directive 98/79/EC is highly desirable. 2.Experience: A minimum of 10 years of experience in either the medical device or pharmaceutical/biotech industry, with a minimum of 3 years in a quality role. 3.Education: Bachelor’s degree in biology, chemistry, or another scientific discipline. Other educational experience will be considered in conjunction with work experience. 4.Strong oral and written communication skills and adept at establishing interpersonal relationships. 5.Proven ability to work in a team environment, balancing compliance risk with business need. Note :
8:00AM - 4:30PM
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.