Quality Engineer

Quality Engineer II-Temporal (1 año)
Job Summary:The Quality Engineer II will serve as a technical quality subject‑matter expert to proactively manage quality risks, resolve potential issues, and drive continuous quality improvement at the Costa Rica CooperMedical site. This role supports product quality, safety, and effectiveness while maintaining compliance with current Good Manufacturing Practices (cGMP), FDA Quality System Regulations, ISO 13485, ISO 13408, MDSAP, EU MDR, and other applicable quality standards.
Essential Functions & Accountabilities:Lead and support quality engineering activities for manufacturing processes, including process validation, equipment qualification (IQ/OQ/PQ), and change management.Lead root cause investigations and corrective and preventive action (CAPA) using structured problem-solving methodologies.Manage and support the investigation, documentation, and disposition of nonconformances and deviations in accordance with quality system requirements.Maintain a working knowledge of aseptic processing concepts and implement requirements defined in a contamination control strategy.Partner with site leadership to support internal and external audits and inspections, and when necessary, represent Quality Assurance as a subject matter expert.Analyze quality metrics and trends; drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.Provide mentorship and technical guidance to junior quality engineers and quality inspectors.Collaborate cross-functionally with Manufacturing, R&D, Supply Chain, Regulatory Affairs, and other groups to ensure product quality and compliance throughout the product lifecycle.Where necessary, support supplier quality activities, including supplier qualification, performance monitoring, and issue resolution.Serve as quality representative on cross-functional teams for new product introduction (NPI), design transfer, and manufacturing scale-up.Crosstrain with multiple value streams as required by quality management.Perform other duties as assigned.
QualificationsKnowledge, Skills and Abilities:In-depth knowledge of ISO 13485, ISO 13408, EU MDR, MDSAP, and other global standards.Ability to work in a matrixed organization, developing strong relationships with all levels of staff and management, partnering across multidisciplinary teams (internal/external).Hands-on experience with process validation, CAPA, nonconformance management, and change control.Strong time management skills to drive multiple projects to completion on time.Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).Strong data analysis, negotiation, and problem-solving skills.Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.Experience in participating in regulatory audits/inspections is required.Proficient in reading, writing, and communicating in the English language.
Work Environment:Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.Occasionally lift to 35 pounds.
Experience:3+ years of experience in fertility, in-vitro diagnostics (IVD), pharmaceutical, medical device or healthcare industry related experience.3+ years of experience in an aseptic processing environment.3+ years of quality systems background experience (NCMRs, CAPAs, Validations, Change Control, Training).3+ years of experience managing external audits.3+ years of experience in Quality Management/Quality Systems/Audit Program Management.Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved pre-post integration.
Education:Bachelor’s degree in a health, Engineering or Science field required; Advanced degree preferred.Certified Lead Auditor (ISO 13485:2016) is preferred.ASQ or equivalent certification and/or relevant work experience is highly preferred. Other Professional certification is preferred (i.e. CQA, CQE, SQE, CQM, etc.).