Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develop and implements methods and procedures for inspecting, testing and evaluating products and production equipment. Performs statistical analysis. Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists . Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 1 years of experience.
What are the top 3 things you are looking for in a candidates experience:
Bachelor’s or Master’s degree in Mechanical, Industrial, Electrical Engineering, or related field preferred.
Experience in FDA/ISO-regulated manufacturing environments, including GMP compliance, inspection readiness, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management.
Knowledge of validation and manufacturing processes, including equipment, process, product, and software validation (IQ/OQ/PQ), risk-based validation, and manufacturing controls.
Proficiency in problem-solving, risk assessment, and data analysis tools, including FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending, and process monitoring.
Experience with quality and business systems (e.g., Minitab, JMP, Excel, Power BI, SAP) and strong communication, collaboration, continuous improvement, and critical-thinking skills; Lean Six Sigma certification and automation/programming experience are preferred.
Education Required: Engineering bachelor degree + 2 years experience
**Weil Group is proud to be an Equal Employment Opportunity Employer.**
Quality Engineer II • Humacao, PR, USA
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