Mount Olive, United States
11 months ago
This position is for a Senior Quality Engineer with primary responsibility to provide direction in the areas of Design Controls, Risk Management and Design Transfer to cross-functional teams for new product development and/or commercialized product. This role will be responsible for reviewing and approving design changes/change control requests that meet quality requirements. This position requires demonstrated ability to effectively communicate with peers and management.
This position will be responsible for being the Quality Assurance Subject Matter Expert (SME) for Design Controls, Design Transfer and other change projects, including engineering change and manufacturing process change projects.
- Serve as reviewer and approver for Design Changes
- Provide guidance and direction in the areas of Design Controls, Risk Management and Design Transfer to cross functional teams
- Provide guidance on creation of design change implementation plans, including supporting creation of validation plans, protocols and reports
- Provide guidance and direction for manufacturing changes
Education: Bachelors degree in science of engineering field of study
Certifications: Certified Quality Engineer preferred
Required Knowledge/Skills and Experience:
- Demonstrated comprehensive understanding Design Controls, Risk Management and Design Transfer requirements
- Demonstrated understanding of manufacturing operations and design change/change control implementation activities
- In-depth knowledge of requirements related to ISO 13485 and FDA QSR
- Experience with reviewing and approving design changes/change control packages
- Strong organizational skills and ability to prioritize
- 5-8 years successful experience working in medical device or other regulated industry
- Proficient with Microsoft Office (Excel, PowerPoint, Word, Visio, etc)
- Ability to communicate effectively within a technical environment
- Demonstrated leadership capabilities
Direction of Others:
This is an individual contributor role. Provides specialized direction to professional counterparts on teams.
Key Working Relationships: Location will be Flanders, NJ Will work with teams in the US and EU