Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you will make an impact:
• Investigate moderately complex supplier-related product quality and compliance issues (e.g., CAPA, SCAR, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
• Optimize to optimize moderately complex Receiving inspection processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve processes, and reduce risk
• Develop, update, and maintain technical content of risk management files
• Develop and validate measurement methods
• Develop training and documentation materials for processes (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Assign support tasks; gives instruction to technicians/inspectors on conducting tests; trains technicians/inspectors and provides feedback; and may coordinate technicians/inspectors work
• Support supplier file maintenance (Notice of change, agreements and quality metrices)
• Lead supplier surveillance/qualification audits
• Other incidental duties as assigned by leadership
What you'll need (Required):
Bachelor's Degree in Engineering or Scientific field, 2 years experience prior industry work experience Required or
Master's Degree or equivalent in + internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Required
What else we look for (Preferred):
• Good computer skills in usage of MS Office Suite; CAD experience preferred
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
