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. 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.

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 Quality Assurance Specialist III will be based in our Houston, TX Life Science R&D lab supporting the new product development process, risk management and transfer to production

Essential Functions & Accountabilities:

• 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. Ensuring stakeholders are adhering to company policies and templates.

☒ Change Management Program: Review, approve and track changes to approved procedures, validated software and processes, qualified equipment. Review the change task completion. Track and facilitate investigation in cross functional impacted teal to support closure of Change Control.

☒ 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

☐ Supply/ Vendor Management: Supplier qualification, reassessment activities, quality agreements, quality score cards. Oversee the process is maintained and approved according to processes.

☒ 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 records for completeness of all required testing, specifications and documents for various processes.

☐ Compliance: Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation. aid in tracking and trending of internal and external findings, investigation and implementation of corrective/ preventive measures.

• 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 cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.

• Create and implement a training program for the QMS processes to educate Quality Assurance customers.

• Perform other Quality Assurance Duties as required.

Travel:

☒Hybrid (1-3 days a week onsite)

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• Bachelor's degree (BA/BS) [BS1] [2] from four-year college or university or associate degree (A.A.) with four to six years related experience and/or training.

• OR six to eight years related experience and/or training.

• OR equivalent combination of education and experience.

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

• Candidate should demonstrate knowledge of regulations and standards such as:

☒CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards: ISO 15189 & ISO 13485

☐AABB, AATB, FDA (HCT/P, cGMP, cGTP), 21CFR1271, FACT and ISO 9001 regulations

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.