Quality Assurance Specialist

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 experience and/or training.

• OR four to six years related experience and/or training; or equivalent combination of education and experience.

• 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.

• Canidates must show knowledge and proficiency in the Quality Assurance Specialist I role

• Candidate should demonstrate knowledge of regulations and standards such as:

☐ CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards: ISO 15189 Medical Laboratories

☒ AABB, AATB, FACT, FDA (HCT/P, cGMP, cGTP), 21CFR 1271, Health Canada and ISO regulations

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.