The Staff Development Quality Engineer II is responsible for quality leadership and support of new product development and technology research projects for Biosciences Instruments and Reagents. This individual will ensure that the design control requirements are implemented and followed, will support multiple product development projects for Biosciences and will ensure that the quality objectives are met during the product development life cycle.
Responsibilities:
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- Independently manages and monitors quality needs of the new product project and all major projects as assigned.
- Escalates resource issues, constraints and delays to the quality manager or director.
- Oversees and provides guidance to ensure that all activities are performed in accordance with quality system and regulatory requirements.
- Applies and mentors/coaches the application of technical principles, theories, concepts and quality tools to complex systems and process.
- Manages quality engineering support of Design Control activities, including quality planning, design verification & validation activities, design reviews, design transfer etc.
- Performs, mentors and coach others on effective root cause investigations and corrective actions to maintain effective and compliant quality systems.
- Lead implementation and utilization of quality tools such as six sigma, risk management, SPC, root cause analysis, and DOE.
- Required to present management status updates
Requirements:
- Minimum of B.S. in Engineering, Science (Chemistry or Physics). Master of Science in Engineering, Science is desired.
- Minimum of 10 years' experience in quality engineering or similar engineering discipline.
- Minimum of 8 years' experience supporting product development lifecycle (R&D, manufacturing, etc.) in Medical or pharmaceutical industry with responsibilities for quality management.
- Assets:
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- CQE and/or CMQ/OE preferred.
- Six-Sigma certification is preferred.
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- Strong understanding and implementation experience of design controls, 21CFR820, ISO13485, ISO 9001, ISO14971, IVDR and other applicable medical device regulations.
- Sound understanding of basic quality engineering sciences, including statistical process control (SPC) methods and application, quality planning, failure analysis investigation, risk management and process and software validation.
- Practical knowledge in design control and process control in a regulated industry.
- Have a strong track record working with cross-functional product development teams.
- Expert in delivering business critical goals within a phase-gate based product development process.
- Expert in the development of risk management, applications of six sigma and daily management tools to drive cohesion and velocity.
- Strategic thinking and leadership skills; ability to develop strategies into clear actionable objectives and measurements. Ability to understand implications and impacts across multiple functions.
- Skilled at facilitating team dynamics.
- Possess the skills and aptitude to engage and influence other functions involved in the development of new products.
- Demonstrated ability to influence without authority and deal effectively with ambiguity.
- The ability to prepare and understand technical documentation such as engineering drawings, operating procedures, work instructions, validations etc.
- Strong communication, problem solving, organizational and interpersonal skills.
