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