Quality Engineer

Overview

The Quality Engineer is responsible for understanding customer quality related requirements, driving internal efforts for root cause and quality improvement, implementing and maintaining ISO 13485 and regulatory requirements while supporting our high standards of precision and quality products in the manufacturing and inspection of medical device parts.

• Work closely with manufacturing and secondary operations using a hands-on, supportive approach to ensure all necessary controls are implemented and followed to be compliant with ISO 13485 and FDA QMSR requirements.
• Work directly with engineering and operations in product launch activities including development of systems and process controls, and creation / submission of PPAP (Production Part Approval Process), First article Inspections (FAI) per customer requirements.
• Interface directly with medical device OEM customers to provide support on quality issues / nonconformances, product launch projects, improvement projects, and corrective actions.
• Lead/Drive corrective, preventive, and closure actions for project issues related to product quality and/or non-conformance using root cause analysis and problem solving and improvement tools.
• Assist with implementation of ISO 13485 and FDA QMSR quality systems.
• Participate in/lead internal, customer, and regulatory audits, including preparation and follow-up actions.
• Lead/Develop/Use/Report on quality Key Process Indicators (e.g. incoming and in-process quality trends; returns analysis categorization and corrective action activity, etc.) to determine process effectiveness, identify areas for improvement, develop best practices, make recommendations, and drive continuous quality improvement with the assigned team(s) and customers.
• Perform analysis of data to identify trends and recommend updates to changes to the quality system standards, procedures, work instructions, forms when necessary.
• Establish and participate in supplier qualification/development activities including raw material and outside process suppliers.
• Use statistical methods to improve quality and manufacturing processes. Understand and use process capability, statistical process control (SPC), and other statistical analysis methods using Minitab or other software that may include probability / hypothesis testing, design of experiments, statistical distribution analysis.
• Develops sampling plans by applying attribute, variable, and sequential sampling methods which may include establishing statistical confidence levels by identifying sample size and acceptable error.
• Contributes to team effort by accomplishing related results as needed.

• Strong interpersonal communication and presentation skills needed to interact with internal and external customers as well as with all levels within the company.
• Must demonstrate excellent writing skills with ability to prepare/review and/or approve technical documentation.
• Thorough knowledge and experience surrounding quality control inspection & measurement methods.
• Ability to work in an entrepreneurial, fast-paced and rapidly evolving environment.

• Previous Medical Device experience in a quality role is preferred but not required.
• Thorough knowledge of ISO 13485 standards and FDA 21 CFR part 820
• Minimum Bachelor’s Degree in an Engineering or Science discipline
• Green Belt or ASQ certification a plus.
• Proven problem-solving experience