Quality Assurance Investigator
Position Type: Contract
Position Location: Allentown, PA
Position Pay: $30/HR - $33/HR (Depending on Experience)
Responsibilities:
- Focus on nonconformance (deviation) investigations.
- Perform all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations.
- Plays a vital role in ensuring the highest quality and safety standards of our medical device products.
- Supporting all stages of manufacturing with conducting and writing incidents and deviation investigations.
- Work cross-functionally with Operations and various support groups (Quality and Engineering teams) to investigate root causes, implement effective corrective and preventative actions, and perform thorough product impact analyses.
- Independently author and resolve deviations in order to meet production and product release requirements
- Communicating across multiple groups and levels to drive deviation closure
- Identifying interdepartmental process improvements and working cross-functionally to-implement them
- Utilizing advanced root cause analysis techniques and technical impact analyses during the deviation investigation process
- Managing multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
- Communicating (both written and verbal) progress and updates across multiple levels of the organization
- Performing more complex deviation investigations
Requirements:
- 4-year degree in Engineering or Science background (Mechanical, Electrical, etc.); Will consider Entry level engineer
- Previous experience with proper GDP, Good Documentation Practices will be helpful.
- Excellent written and verbal communication skills with demonstrated ability to work cross-functionally across different functional groups and demonstrated ability to prioritize and manage multiple tasks effectively and efficiently.
- Strong root cause analysis experience and technical writing experience
- Diligent with strong analytical and critical thinking skills
- Organized and disciplined to manage multiple tasks and priorities
- Adept and able to work independently and as an engaged team member
- Utilize computerized systems for daily performance of tasks. Computer Skills include Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Express energy, show accountability, have ability to multi-task and work in a fast-paced, quality-rich environment