Compliance Analyst

Job DescriptionCooperVision (CVI) is recruiting a Compliance Analyst. This position supports and is responsible for specific tasks and functions within the company’s Quality System areas including end to end complaints management. Performs ongoing reviews and assessments, including internal and external audits, compliance assessments and related projects. The position is based in Juana Diaz, Puerto Rico, and works onsite. Essential Functions & Accountabilities: Performing end-to-end complaints management for manufacturing and packaging operations. Performing routine monitoring audits (including lot and/or document spot screenings). Generating NCR for non-conforming materials.

Lead NCR resolutionAssuring compliance with laws and regulationsDefines tactics for Quality First Pass, DPM & CPM Metric (once a year)Ensuring completeness of quality investigations, Complaints, NCRs, CAPA’s and other related Quality incidences. Investigation (data gathering of quality issue)Identifying and implementing corrective/preventive actionsPreparing rework protocols or memos for NCRsReviewing/approving NCRs investigations and dispositionMonitoring and measuring quality KPI’sKeeping the business aware of actual quality KPI’s. Developing actions to improve quality KPI’sDeveloping supporting documentation for Quality Improvements. May provide training. Supports the development and update of procedures. Other duties as assigned.

Qualifications (Knowledge, Skills, and Abilities): Knowledge of GMP/QSR. Knowledge on ISO13485, 21 CFR Part 820, EU MDR, QMS, and MDSAP. Excellent interpersonal, verbal, and written communication skills in English and Spanish. Service oriented with strong organization skills. Advanced computer systems proficiency including MS Office. Ability to manage multiple priorities. Collaboration and teamwork oriented. Experience: Three (3) years of related Quality and compliance experience in the regulated manufacturing industry. Demonstrated knowledge and experience of the FDA Quality System Regulation (21 CFR Part 820), MDSAP, ISO standards, and other related regulations, as well as knowledge in all major manufacturing processes and support systems. Education:

Bachelor’s degree in science, engineering, or related technical field required. “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. ”#onsite