Quality Assurances Systems Specialist I

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. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. 

Work location: Trumbull, CT or Livingston, NJ (on-site)

Scope: 

Responsible coordination and collaboration of Health Hazard Evaluation (HHE) and Recall activities related to all CooperSurgical products. 

Job Summary:

You will manage and execute HHE and recall activities within regulated timelines and requirements. You will lead through collaboration with cross functional team members, coordinate the collection of required information and data, and if required communicate field actions to competent authorities. 

• Determine if a Health Hazard Evaluation (HHE) is required.
• Coordinate the collection of data for the HHE and collaborate with the Risk Management designee as needed.
• If recall is determined as required, work within procedure and regulatory requirements to coordinate recall activities with the cross functional team.
• Draft customer recall notification letters with input from cross-functional teams.
• Draft and submit regulatory recall reports to competent authorities.
• Manage, collect, and process customer recall acknowledgement responses.
• Manage product return by customers and collaborate with warehouse staff regarding returns, count, and disposition.
• Support recall activities including, but not limited to answering customer inquiries, issue RMAs to customers.
• Draft and submit recall termination requests.

Travel: Less than 5%

Knowledge, Skills and Abilities:

• Strong verbal and written communication skills.

• Strong team player.

• Excellent organizational skills.

• Demonstrate professional approach when working with internal and external customers. 

• Advanced Microsoft Office (Outlook, Word, Excel, etc.).

• Advanced knowledge of global regulatory requirements for recall activities including, but not limited to 21 CFR Part 805, 806, Health Canada GUI-0054, EU MDR 2017/745, Therapeutic Goods of Australia ARGMD, etc.

Work Environment:

• Prolonged sitting in front of a computer

Experience:

• 3-5 years of experience in a Medical Device Quality Assurance/Regulatory environment
• At least one year working experience in Recall/Field Actions
• 2+ years’ experience in Risk Management a plus.
• Experience working in regulated environments or knowledge of regulatory requirements, such as FDA Quality System Regulations, 21 CFR Part 806, and EU MDR 2017/745, and international standards, such as ISO 13485, ISO 14971, and IEC 62304. 
• Meeting internal KPIs. 
• Experience leading and performing activities, including driving successful countermeasures. 
• Demonstrate collaborative patient and customer focus mindset.

Education:

• Bachelor's degree in engineering or health related field. 

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Our Benefits:<