Quality Assurance Specialist

Quality Assurance Specialist

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.

Responsibilities

Provide quality oversight and support as needed by quality customers. Support and partake in 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. Track and facilitate investigation in cross functional impacted team 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 medical records for completeness of all required testing 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.
• Perform data entry, data analysis, tracking, trending, creating graphs and reports as required for each Quality Management System modules monitoring timeliness and effectiveness.
• Perform compliance review on executed records from completeness of all required testing and documents for various processes.
• Maintain understanding of root cause analysis techniques to help quality customers with investigation of complex matters on root cause analysis techniques and processes.
• Identification of risk and risk mitigation
• Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.
• Recognizes errors in records and resolves them in a timely manner.
• Perform other Quality Assurance Duties as required.

Qualifications

Knowledge, Skills and Abilities :

Computer Skills :

Adaptability :

Decision Making :

Initiative :

Results Oriented :

Task Management :

Work Environment :

Education :

Candidates must show knowledge and proficiency in the Quality Assurance Specialist I role Candidate should demonstrate knowledge of regulations and standards such as : CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards : ISO 15189 Medical Laboratories AABB, AATB, FACT, FDA (HCT / P, cGMP, cGTP), 21CFR 1271, Health Canada and ISO 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. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $85,000 - $90,000. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other