Quality System Associate (Medical Device/ Pharma/Manufacturing)
Woodinville, WA 98072 ( Onsite - *Local candidates only )
$32 – 34 ( Weekly pay! + Benefits )
7 month contract ( Excellent potential for permeant and extension)
Full-time: M-F
Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives! The candidate will attend cross function Daily Management meetings and represent QA following up on blocking issues and implementing counter measures. The candidate will manage the Material Review Board and ensure thorough documentation of non-conformities and risk-based determination of CAPA. The candidate will review data for trends, manage corrections and corrective action and support GSC and business partners as requested.
Duties:
- Improve the overall efficiency of the Quality Management System by launching initiatives to prevent deviation recurrence by analyzing nonconformances and complaints for trends.
- Support release of high-quality products by managing the MRB and making risk-based and compliant decisions.
- Maintain the integrity of the QMS by ensuring investigations are well designed, executed and documented.
- Provide confidence to internal and external customers by following through on actions and continually improving processes.
- Facilitate risk management practices and ensure all quality requirements are satisfied.
Requirements:
- Bachelor’s degree or equivalent experience.
- 1-4 yrs experience understanding of GMP (Good Manufacturing Practices) and or ISO regulations and validation principles preferred.
- Basic understanding of risk management best practices and regulations for the medical device industry or similar industry.
- Bonus: Quality Engineering, Six Sigma Green Belt Certifications
- Bonus: Skilled in statistical methods, statistical process control and experimental design
- Ability to work well in fast paced and cross-functional teams.