Quality Assurance Coordinator

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 Post Market Surveillance Coordinator collaborates and manages day to day operations including:

• Information communicated to the shared department email inbox.

• Execution of field action tasks like field safety notice translations, notice mailings, tracking of customer acknowledgement responses.

• Collaborate with cross-functional team to collect data and complete documents like Health Hazard Evaluation (HHE), and Field Safety Notices (FSN). role ensures on-going regulatory compliance and continuous product and process improvements. You will support the CooperSurgical Post Market Surveillance process by working in partnership with our Commercial sales teams, Operations (QA and Manufacturing), and other Post Market Surveillance teams.

• Issuance of Return Merchandise Authorization (RMA) for field product return as needed.

• Management of the shared email inbox and Requests for Additional Information (RFAI).

• Proper filing of all documentation for HHEs and Field Actions in the designated repository.

• Ensure reporting requirements are compliant with CSI Policy in accordance with applicable laws and regulations worldwide.

• Work to meet and maintain department metrics that complement CSI goals, targets, and objectives.

• Support and maintain compliance with disposition and reporting activities world-wide.

• Minimum Bachelor's degree in Biomedical Science or a related field.

• Minimum 1 year of Regulatory experience

• Minimum 3 years of Quality Management Systems experience

• Project Manager experience a plus

• CAPA Management lead/owner experience a plus.

• Prior experience working within a global organization/team.

• Related experience in Correction & Removal processes, regulatory submissions, Risk Management, and/or project management preferred within the medical device or similar industry.

• An ideal candidate will come from a direct correction and removal role within the medical device industry having worked with software.

• Strong organizational skills.

• Ability to communicate with various stakeholders both verbally and in writing.

• Ability to balance multiple projects/tasks, with a high degree of initiative.

• Flexibility to adapt to an ever-changing environment.

• Excellent verbal and written communication skills.

• Good understanding of the Quality Management System and the associated interrelationships

• Knowledge of FDA regulations 21 CFR 806, 820 and ISO standards 13485, Health Canada, and EU MDR 2017/745 and MDCG 2023-3.

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.