Quality Engineer I

General Duties and Responsibilities:

• Support daily manufacturing activities and work with Engineers to resolve line issues and implement corrective actions.
• Provide technical support for incoming inspection and lot release testing activities.
• Provide support and leadership to Product Improvement Teams as Quality Engineer.
• Manage customer complaint investigations from initiation through investigation and closure. Ensure reportability assessments are made in a timely manner for each complaint. Ensure quality, in-depth investigations are performed, including effective root cause and corrective action assessments.
• Manage NCMR investigations from initiation through investigation and closure. Perform product dispositions in a timely manner. Ensure quality, in-depth investigations are performed, focusing on elimination of the defect condition through effective root cause and corrective action problem solving techniques.
• Provide input to the Supplier Quality program by evaluating potential suppliers, managing supplier corrective actions, performing supplier audits, and evaluating quality metrics.
• Support the Internal Audit program by auditing, identifying and correcting deficiencies, creating reports, and conducting verifying effectiveness of corrective actions.
• Provide quality engineering support to engineering project teams associated with new product development projects or process improvement projects. .
• Revise quality system procedures (SOPs and WIs).
• Write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, test method validations, and Gage R&R studies.
• Develop and maintain risk management files and quality control plans for components, devices and processes.
• Provide training and/or technical guidance to QA Technicians and production staff as required.
• Uses statistical analyses and interpretations for investigations, specification setting activities, and test protocols.
• Participate in inspections with FDA, ISO, MDD, MDSAP and other regulatory agencies.
• Support major quality projects which result in CPAR files.

Qualifications:

• Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience.
• A minimum of 2 years of experience in a quality role in a regulated industry such as medical device or pharmaceutical is preferred.
• Familiarity with FDA Quality System Regulation, MDD, ISO 9001, ISO13485, and ISO 14971 is preferred.
• Strong unbiased advocate of compliance.
• Ability to work efficiently in a team environment.
• Must possess technical writing, project management and fundamental problem-solving skills.
• Experience using word processing, spreadsheet, data management and/or design of experiments software programs. Familiarity with Minitab statistical software preferred.
• Prior experience in auditing is desired.
• Previous experience performing laboratory and/or mechanical testing required.
• Excellent Strong verbal and written communication skills.
• Ability to travel up to 10% of the time