Provide Quality Engineering support to R&D, product development and manufacturing. Key areas of support include Design Control verification and validation activities, risk management/communication, inspection technique support, nonconformance and defect resolution, process capability/process improvement, statistical process control, trending, CAPA and change control management.
Position Description and Responsibilities:
- Support manufacturing process development, optimization & qualification for new product commercialization and product changes
- Develop and implement product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, and FMEAs to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes
- Work with engineering teams within the company as well as contract manufacturers and suppliers to ensure product quality and will provide new product development design assurance as needed.
- Support design, test, and inspection method development, and lead method validation activities.
- Support product and process validation activities for new/existing equipment and/or processes
- Reduce and control Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions
- Perform NCMR and CAPA investigations to ensure compliance with Quality System elements and determine root cause and corrective actions as needed
- Provide guidance on data analysis and statistical tools to conduct or support of trend analysis, root cause analysis, failure investigation, and risk assessment
- Comply with FDA regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments
- Must have a solid understanding of statistical processes and techniques
- Ability to interpret engineering drawings (GD&T)
- Knowledge of Quality Management Systems ISO 13485 and Quality System Regulation (QSR) 21 CFR part 820 required
- Must possess excellent oral and written communication skills demonstrated by the ability to communicate across all levels of the organization, customers and suppliers
- Must possess strong organizational skills, is detail oriented, self-motivated, dependable, flexible, and an excellent problem solver
- Ability to travel up to 10% domestically and internationally
- Six Sigma or Lean certification and training
- ASQ Certified Quality Engineer (CQE) preferred
- BA/BS degree in engineering/scientific discipline
- More than five (5) to ten (10) years of experience in the medical device industry