Quality Engineer / Supplier Quality Engineer

Position Summary:

Provide Quality Engineering support to R&D, product development and manufacturing, as well as contract manufacturing sites and external suppliers. Key areas of support include risk management/communication, inspection technique support, nonconformance and defect resolution, process capability/process improvement, verification/validation activities, CAPA and change management.  

Position Description and Responsibilities:

  • 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
  • Support design, test, and inspection method development, and lead method validation activities
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • 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
  • Lead supplier development activities by conducting reviews and visiting supplier sites, assessing suppliers’ technical competency and compliance to requirements, and developing and implementing improvements/modes of control within the supplier processes to minimize non-conformances
  • Manage Receiving Inspection Team and provide engineering support to Receiving Inspection by ensuring objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Perform internal and supplier Quality System audits and CAPAs 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 regular requirements (ISO), Company policies, operating procedures, processes, and task assignments

Position Qualifications:

  • Must have a solid understanding of statistical processes and techniques
  • Auditing background preferred
  • Ability to interpret engineering drawings (GD&T) and experience with CMM and other multi-mode measurement systems preferred
  • Knowledge of Quality Management Systems ISO 13485:2003 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 20% domestically and internationally

Desirable Skills:

  • Six Sigma, Lean, or ASQ Certification and training
  • Qualified lead auditor certification or equivalent training

Minimum Education

  • BA/BS degree in engineering/scientific discipline, with a minimum five years of experience or an equivalent combination of education or experience in the medical device industry 

Minimum Experience

  • Minimum five years of experience in the medical device industry 

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