Senior Life Science Quality Assurance Specialist

Life Science Quality Assurance Specialist III

Cooper Surgical 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 Cooper Companies, 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.

Work location:

Livingston, NJ (on-site)

The Life Science Quality Assurance Specialist III is a senior-level employee who reports to the Life Science Quality Manager. The role will own Quality System(s) working with stakeholders in facilitating meetings, providing data from tracking and trending, leading quality and continuous improvements. The Specialist III will have the responsibility to train the organization on the Quality System(s), as well as mentoring Quality Team members.

The individual will help drive change that will remediate the risks to internal and external customers.

The Life Science Quality Assurance Specialist III is primarily responsible for establishing, developing, implementing, maintaining and improving Quality System processes and programs to include:
Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint), Document Control Program, Supplier Qualification, Validations, and Product Transfer. In this role the candidate will mentor and train new personnel on the Quality System(s). The Quality Specialist III will partner with stakeholders to improve the quality program and quality culture within the organization. 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.

• Maintains a culture of quality awareness, teamwork, and cooperation with Quality customers.
• Provide Quality oversight, support and engagement as needed by Operations.
• Owner of Quality Management System Processes such as:
• Document Control Program: review, approval, and maintenance of company Standard Operating Procedure via electronic Document Quality Management System.
• Change Management Program:
  Review, approve and track changes to approved procedures, validated software and processes, qualified equipment. Review the change task completion.
• 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, Change Controls and CAPA
• Supply/ Vendor Management:
  Supplier qualification, reassessment activities, quality agreements, quality score cards. Oversee the process is maintained and approved according to processes.
• Audit Program: aid in tracking and trending of internal and external findings, investigation and implementation of corrective/ preventive measures.
• 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.
• Facilitate meetings, provide system visibility, communicate status, and facilitate closure of aging items.
• Gather performance metrics and coordinate Management review inputs from various contributing departments.
• Track, trend, and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks.
• Work…