Quality Assurance Senior Specialist

Job Description

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 .

Responsibilities

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, Non conformance, 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.

Responsabilities:

Review, approval, and maintenance of company Standard Operating Procedure

R eview, approve and track changes to approved procedures, validated software and processes, qualified equipment

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

Supplier qualification, reassessment activities, quality agreements, quality score cards

Review and approval of equipment, systems validation/ qualification, and any design transfer to operations

Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation

Gather performance metrics and coordinate Management review input

Qualifications

Qualification:

Bachelor’s degree (BA/BS) from four-year college or university or associate degree (A.A.) with four to six years related experience and/or training.

Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.

Candidates must show knowledge and proficiency in the Quality Assurance Specialist II role

Candidate should demonstrate knowledge of regulations and standards ISO 15189 Medical Laboratories