The Quality Engineer II is responsible for providing quality assurance knowledge and hands-on support for all aspects of production operations, quality control activities and transfer of new product launches and, ensuring that all site operations remain compliant with all FDA regulations, ISO standards, customer requirements, and internal policies and procedures.
Under the direction of the site Quality Manager and or guidance from the Sr. Quality Engineer, the Quality Engineer II will be the owner of: Quality planning; Validations; FMEA and risk analysis; Capability studies; Developing, reviewing, and/or revising procedures; Variance Complaint investigation and resolution; RCA analysis; corrective and preventative actions; All other areas of quality control programs in a GMP and ISO 13485 environment.
The Quality Engineer II will also be responsible for providing Quality representation and support in: the ongoing development, evaluation, and improvements of CooperSurgical quality programs and systems; quality assurance testing methodology; internal and external audits; vendor qualifications; training initiatives and programs; cross-functional process improvement activities; and any other business initiatives requiring Quality support.
Essential Functions: 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 recommend improvements opportunities to processes, procedures and systems) to increase quality compliance.
Participate in validation activities, included but no limited to draft and/or review 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.
Ensures that the disposition of non-conforming materials meet 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 as owners, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Support all internal and external audits as subject matter experts.
Supervise quality inspectors to ensure correct levels of service to production based on the plant priorities.
Train Quality and Manufacturing personnel on specifications, inspection and testing activities, new product audits, and environmental controls to ensure understanding and compliance, request training, training support, and/or re-trainings as needed.
Qualifications: Bachelor's degree in engineering required.
Experience in medical device manufacturing.
3+ years of work experience in 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 as owner.
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 both in English and Spanish.
Able to read and interpret blueprints and familiar with geometric dimension & tolerance (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.
