Senior Quality Engineer - (Segundo Turno) (Chihuahua)

Senior Quality Engineer (2nd Shift)

Purpose

Participate in new 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 *****, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.

Responsibilities

• In support of new product/process development, quality operations or quality assurance.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.
• Develop and establish effective quality control and support associated risk management plans.
• Write, review and/or approve 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).
• Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.
• 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 all planning necessary to ensure effective product acceptance, including, but not limited to, part qualifications, specification development, and sampling plans.
• Support vendor audits as technical lead as needed and support Supplier Quality as Quality representative as appropriate.
• Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
• Assist in complaint analysis as appropriate.
• Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
• Participate in design reviews and pre‑validation assessments to ensure the safe and environmentally sound start‑up of new processes.
• Make decisions independently on engineering problems and methods and represent the organization in conferences to resolve important questions and to plan and coordinate work.
• Consult with supervisor and provide guidance as needed concerning unusual problems.

Qualifications

• Bachelor's degree in a related field.
• Minimum of 4-6 years of quality position.
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
• Knowledge of GD&T is desirable.
• Ability to develop and implement Quality standards.
• Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.
• Thorough knowledge of leading‑edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.