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. As a business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people 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. Learn more at www.coopersurgical.com.

• Follow and ensure that all personnel comply with FDA regulations, ISO standards, customer requirements, and SOPs as defined by CooperSurgical policies and procedures.
• Represent Quality in signing on Change Orders.
• Manage all Quality responsibilities for assigned manufacturing changes and transfer of new product launches.
• Perform process improvement recommendations and identify opportunities to improve processes, procedures, and systems to increase quality compliance.
• Participate in validation activities, including but not limited to drafting and/or reviewing protocols and reports; qualify/validate production processes for Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
• Ensure that all documentation is completed in a timely manner and follows established policies, practices, and procedures.
• Investigate customer complaints, including root-cause analysis; develop and implement corrective action plans.
• Ensure that the disposition of non-conforming materials meets all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
• Effectively communicate and interact in a matrix environment.
• Participate in CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analysis.
• Support all internal and external audits.
• Train Quality and Manufacturing personnel on specifications, inspection and testing activities, new product audits, and environmental controls to ensure understanding and compliance; request training, provide training support, and/or coordinate re-training as needed.
• Bachelor’s degree in Engineering required.
• Experience in medical device manufacturing.
• 3+ years of work experience in a Quality Engineering role or equivalent.
• Working knowledge of regulated environments (ISO 13485, 21 CFR 820, and/or other regulations).
• Root Cause Analysis (CAPA/NCR) experience.
• Experience in planning Process Validation, IQ/OQ/PQ/MSA (software qualification a plus).
• Knowledge of statistical analysis of data and related tools.
• Advanced computer capabilities including Microsoft Office software.
• Strong interpersonal, written, and oral communication skills in both English and Spanish.
• Ability to read and interpret blueprints and familiarity with Geometric Dimensioning & Tolerancing (GD&T) procedures and requirements.

CooperSurgical does not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic characteristic, or other characteristics protected by law. Company policy also prohibits harassment of employees or applicants based on these characteristics.