Quality Assurance Specialist II

4 weeks ago


New York, New York, United States Cooper Companies Full time
Job Title: Quality Assurance Specialist II

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist II to join our team at CooperSurgical. The successful candidate will be responsible for maintaining quality system processes and programs, including supplier quality, investigation systems, quality event reporting, and training.

Key Responsibilities:

* Provide quality oversight and support as needed by quality customers
* 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 module monitoring timeliness and effectiveness
* Perform compliance review on executed records from completeness of all required testing and documents for various processes
* Prepare and/or execute internal and external audit functions (e.g. host, support auditor, or document manager)
* 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

Requirements:

* Bachelor's degree (BA) from four-year college or university or Associates degree (A.A.) with three to five years related experience and/or training
* OR four to six years related experience and/or training; or equivalent combination of education and experience
* 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

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. 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.

What We Offer:

* An outstanding total compensation plan
* Medical coverage
* 401(k)
* Parental leave
* Fertility benefits
* Paid time off for vacation, personal, sick and holidays

How to Apply:

If you are a motivated and detail-oriented individual with a passion for quality assurance, please submit your application. We look forward to hearing from you.

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