Ingeniero de Calidad II - Tercer Turno

Purpose

Under general supervision, participate in new and sustaining product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.

Primary Responsibilities

• Supports quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of the product.
• Assists in a supporting role on new product development, sustaining and supply chain quality projects.
• Assist in the development of effective quality control and associated risk management plans.
• Write process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
• Help to ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDR, and product is properly transferred to manufacturing.
• Provide support in quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.
• Aid in planning necessary to ensure effective product acceptance, including, but not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
• Support vendor audits as technical lead as needed and support Supplier Quality as Franchise Quality representative as appropriate.
• Support NC, CAPA, Internal Audit, Training and QS activities as needed and ensures compliance to all applicable due dates.
• Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
• Assist in complaint analysis as appropriate.
• Aid Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
• Moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives.
• Supervisor or Sr./Staff/PMgr screens assignments for unusual or difficult problems and reviews techniques and procedures to be applied on non-routine work.

Qualifications / Requirements

• Bachelor’s degree in a related field, along with minimum 2 – 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required.
• Master’s degree is preferred.
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
• Familiarity of GD&T (Geometric Dimensioning and Tolerancing) concepts is desirable.
• Ability to develop and implement Quality standards.
• Some knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices.
• Some knowledge of or education in Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
• Ability to apply project management skills to fulfill new product development requirements.
• Problem solving skills.
• Verbal and written communication skills and ability to effectively communicate with internal and external personnel.