Senior Quality Engineer

Summary of Primary Responsibilities:

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

Desirable 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