Terrific Contract Opportunity!
Our client is one of the world's largest producers of energy-efficient, resource-saving technologies. Come be a part of how digitalization, globalization, urbanization, demographic change, and climate change are transforming our world.
Position: Medical Device Engineer
Location: Walpole Massachusetts 02032
Term: 11 months
- 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 walkthroughs 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.
Is this a good fit? (Requirements):
- Proven understanding of external regulations, particularly with regards to 21 CFR Part 820 and ISO 13485.
- 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.
- Bachelor’s degree in biology, chemistry, or another scientific discipline. Other educational experience will be considered in conjunction with work experience.
- Strong oral and written communication skills and adept at establishing interpersonal relationships.
- Proven ability to work in a team environment, balancing compliance risk with business need.
Even better if you have:
- Working knowledge of the IVDD Directive 98/79/EC.
If this sounds like the perfect fit, apply today