We are seeking a highly skilled candidate for an immediate opening to backfill an employee during a mandatory time-off period. This is a short-term position lasting 3 months, with responsibilities across multiple projects impacting various product lines.

Must Have

Bachelor's degree in Engineering, Science, or a technical field with a minimum of 4 years of experience in Engineering and/or Quality, or an advanced degree with 2 years of relevant experience. Experience in Validation/Qualification activities: writing, coordinating, executing, creating reports, IQ, OQ, PQ, MVPR, etc. Experience in Risk Documentation: writing, reviewing, approving Risk Management files, RPM calculations, Risk Mitigations, etc. Strong statistical background and sampling size determination for attribute or variable data. Ability to work with minimal supervision in a hybrid working setup. Excellent writing, documentation, organizational, and verbal communication skills. Ability to work in a fast-paced environment and meet deadlines. Ability to interact with a diverse team while maintaining high ethical standards. Commitment to the company's core values. Strong Risk Management Experience. Nice to Have ASQ Quality Engineer Certification. Bilingual in English/Spanish preferred but not required. Previous experience in the medical device industry. DMAIC Lean / Six Sigma Certification. Manufacturing experience within a controlled and regulated industry. Responsibilities Provide Quality Engineering support to multiple projects, including supplier quality engineering support. Conduct day-to-day Risk Management reviews and maintain strong Risk Management practices. Develop, execute, analyze, and report on validation/qualification activities such as IQ, OQ, PQ, MVP, and Test Method Validations. Evaluate, review, and update quality records, including design files and process documents, ensuring compliance with ISO standards and local procedures. Oversee the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal and external standards. Provide expertise and guidance in interpreting policies and regulations to assure compliance. Work with various internal and external entities to provide quality engineering and supplier quality engineering support. Prepare reports and necessary documentation for project stakeholders. Develop and apply quality standards and protocols for material processing. Implement inspection, testing, and evaluation methods for product precision and accuracy. Ensure corrective measures meet reliability standards and documentation requirements. Support multiple projects in areas such as design, production control, and research and development. Perform Root Cause Investigation using quality tools when required. Collaborate with cross-functional teams to resolve process issues and implement changes. Apply process control tools and statistical sampling techniques to enhance product quality and flow. Identify, analyze, and manage risk throughout the product life cycle using risk management tools.

Differentiating Factors

Autonomy: Operates independently under limited supervision, coaching lower-level specialists and potentially managing projects.

Organizational Impact: Responsible for projects or processes, contributing to work group objectives through collaboration and consensus building.

Innovation and Complexity: Solves complex problems, improves processes, and provides in-depth analysis with recommendations.

Communication and Influence: Communicates with senior internal and external stakeholders, exchanging information to achieve objectives and influence decisions.

Leadership and Talent Management: Provides guidance and training to other employees, manages projects, and delegates work as needed.

Required Knowledge and Experience: Requires advanced knowledge of the job area, typically obtained through an advanced education combined with experience. Practical knowledge of project management is beneficial. Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.