Essential Duties and Responsibilities:
– Represents Quality Assurance on the New Product Development (NPD) cross-functional team (CFT).
– Interfaces among multiple departments and teams such as R&D, Regulatory Affairs, Advanced Operations, and Marketing to ensure specific product development metrics are met.
– Creates and implements the Risk Management File for an NPD team.
– Leads Risk Management activities for an NPD team, including identifying hazards and harms that may be associated with the medical device.
– Leads Design Reviews for NPD teams to ensure design and process robustness and compliance to Corporate and Divisional design control procedures.
– Leads the exercise of understanding the functional inputs and outputs of the medical device.
– Analyzes, reviews, and approves standard methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment and recommends corrective action.
– Analyzes, reviews, and approves standard manufacturing procedures and engineering systems for medical devices.
– Analyzes, reviews, and approves equipment qualifications in preparation for design verification testing and/or process validation testing.
– Analyzes, reviews, and approves test methods to ensure repeatability and reproducibility.
– Analyzes, reviews, and approves standard process and product protocols.
– Analyzes, reviews, and approves reports and recommends corrective action.
– Provides sound statistical rationale for test sample size determinations.
– Analyzes test data by using sound statistical techniques and communicating the results
– Uses sound statistical rationale to analyze and interpret engineering test data collected during new medical device testing.
– Verifies that new medical devices are technically sound and in compliance with FDA and other regulatory bodies.
– Fundamental knowledge of applicable regulations and standards (e.g. QSR, ISO 13485)
– Improves and/or supports existing processes.
– Supports team initiatives
– May interact with customers to solve product quality issues and /or answer general product questions.
– May work with verbal and/or written instructions.
– May train others in quality assurance / GMP related topics.
Education & Experience:
– Bachelor’s degree in an engineering or science field.
– Minimum of 5 years experience in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering.
– R&D and/or NPD experience preferred.
– Proficient in Microsoft Word, Excel, Power Point, Outlook, Project
– Experience with statistical software packages such as Minitab or JMP is desired.
– Strong verbal & written communication skills.
– Excellent organizational, problem solving, and analytical skills
– Ability to manage priorities and workflow
– Versatility, flexibility, and a willingness to work within constantly changing priorities
– Ability to handle multiple projects and meet deadlines.
– Good judgment with the ability to make timely and sound decisions.
– Working knowledge of data collection, data analysis, and evaluation, and scientific method.
– Ability to observe and note minute inconsistencies.
– Ability to generate, follow, and explain detailed instructions and inspection procedures.
– Ability to complete detailed documentation accurately.
– Ability to analyze and resolve routine issues using independent judgment.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2053878-1793-4376
Tempe, AZ 85283