CooperSurgical is looking for a Quality Assurance Specialist II to maintain and improve their quality system processes, including supplier quality, investigation systems, quality event reporting, training, and document review. The role involves working with cross-functional teams to aid in root cause analysis and risk remediation, ensuring compliance with regulations and industry standards.
Requirements
- Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
- Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.
- Knowledge of Master Control, or similar eQMS a plus
- Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.
- Knowledge and proficiency in the Quality Assurance Specialist I role
- Demonstrate knowledge of regulations and standards such as: CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards: ISO 15189 Medical Laboratories
- Maintain understanding of root cause analysis techniques to help quality customers with investigation of complex matters on root cause analysis techniques and processes.
Responsibilities
- Supplier Quality, Investigation Systems, Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA) management, training, and document review.
- Work with cross functional teams aiding in root cause analysis, risk remediation and management.
- Review, approval, and maintenance of company Standard Operating Procedure via electronic Document Quality Management System.
- Review, approve and track changes to approved procedures, validated software and processes, qualified equipment.
- Review, approve and monitor the events and deviations.
- Complaint handling and investigations Track and facilitate investigation in cross functional team discussions in support of closing Quality Events
- Perform data entry, data analysis, tracking, trending, creating graphs and reports as required for each Quality Management System modules monitoring timeliness and effectiveness.
Other
- Strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Applies a preventative instead of corrective approach
- Positive work attitude that supports teamwork and continuous improvement.
- Excellent critical analytical skills – ability to find root cause of why and issue occurred.
