Quality Assurance Specialist II

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

 CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

The Life Science Quality Assurance Specialist II is a mid-level quality professional responsible in maintaining, quality system processes and programs to include: Supplier Quality, Investigation Systems, Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA) management, training, and document review. In this role the candidate will work with cross functional teams aiding in root cause analysis, risk remediation and management.  The candidate should have 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. 

• Provide Quality oversight and support as needed by Quality customers.
• Support and partake in Quality Management System Processes such as:

☒ Document Control Program: review, approval, and maintenance of company Standard Operating Procedure via electronic Document Quality Management System. Ensuring stakeholders are adhering to company policies and templates. 

☒ Change Management Program: Review, approve and track changes to approved procedures, validated software and processes, qualified equipment. Review the change task completion. Track and facilitate investigation in cross functional impacted teal to support closure of Change Control. 

☒ Deviations and Nonconformances: 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

☐ Supply/ Vendor Management: Supplier qualification, reassessment activities, quality agreements, quality score cards. Oversee the process is maintained and approved according to processes. 

☒ Validations: Review and approval of equipment, systems validation/ qualification, and any design transfer to operations

☒ Quality Metrics: Perform trending analysis and reporting of quality indicators. Identification or risk and process improvements into operations. 

☐ Reviews chart and medical records for completeness of all required testing and documents for various processes.

☒ Compliance: Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation. aid in tracking and trending of internal and external findings, investigation and implementation of corrective/ preventive measures. 

• Perform data entry, data analysis, tracking, trending, creating graphs and reports as required for each Quality Management System modules monitoring timeliness and effectiveness. 
• Perform compliance review on executed records from completeness of all required testing and documents for various processes.
• Maintain understanding of root cause analysis techniques to help quality customers with investigation of complex matters on root cause analysis techniques and processes.
• Identification of risk and risk mitigation 
• Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records. 
• Recognizes errors in records and resolves them in a timely manner.
• Perform other Quality Assurance Duties as required. 

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• Bachelor’s degree (BA) from four-year college or university or Associates degree (A.A.) with three to five years related experie