Life Science Quality Assurance Specialist III

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 business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people 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. [https://www.coopersurgical.com./] Work location: Mississauga, ON, CA (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.

The role is responsible for establishing, maintaining, and improving Quality System processes including deviations, CAPA, and supplier qualification. The specialist will also mentor team members and partner with stakeholders to drive a strong quality culture and continuous improvement.

Requires a Bachelor's degree or an equivalent combination of education and 4-8 years of related experience. Candidates must demonstrate proficiency in quality regulations such as AABB, FDA (HCT/P, cGMP, cGTP), 21CFR1271, and ISO 9001.

• Medical Coverage • 401(k) • Parental Leave • Fertility Benefits • Paid Time Off • Vacation • Personal Days • Sick Leave • Holidays

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Quality Assurance
• Quality System Management
• CAPA
• Change Management
• Root Cause Analysis
• Technical Writing
• Risk Management
• Supplier Qualification
• Validation
• Document Control
• Microsoft Office
• eQMS
• Continuous Improvement
• Cross-functional Collaboration
• Mentoring
• Regulatory Compliance

• Healthcare
• Science & Research
• Manufacturing
• Engineering
• Management & Leadership

Formation minimale

Diplôme collégial

Expérience minimale

5+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine