Senior Quality Engineer

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Position Summary:

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

Position Qualifications:

  • 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

Desired Skills:

  • Six Sigma or Lean certification and training
  • ASQ Certified Quality Engineer (CQE) preferred

Minimum Education:

  • BA/BS degree in engineering/scientific discipline

Minimum Experience:

  • More than five (5) to ten (10) years of experience in the medical device industry