Life Science Quality Assurance Specialist III
About The Position
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: Livingston, NJ (on-site) Scope: 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. Job Summary: 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.
Requirements
- Strong written and verbal communication skills
- Ability to foster cross-functional collaboration and partnerships
- Ability to lead by positive influence
- High level of integrity
- Strong continuous improvement mindset
Responsibilities
- Own Quality System(s)
- Facilitate meetings with stakeholders
- Provide data from tracking and trending
- Lead quality and continuous improvements
- Train the organization on the Quality System(s)
- Mentor Quality Team members
- Drive change to remediate risks to internal and external customers
- Establish, develop, implement, maintain and improve Quality System processes and programs
- Manage Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint)
- Manage Document Control Program
- Manage Supplier Qualification
- Manage Validations
- Manage Product Transfer
- Mentor and train new personnel on the Quality System(s)
- Partner with stakeholders to improve the quality program and quality culture within the organization
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
