Summary:
Responsible for supporting the development, implementation and maintenance of the Quality Management System (QMS) in compliance with regulatory requirements and company standards. The individual in this role performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products. Conducts Corrective and Preventive Action activities, performs root cause analysis and implements corrective actions to eliminate quality problems. Supports supplier quality program by performing audits, managing supplier metrics, and managing supplier corrective action plans. Develops qualification test protocols, performs data analysis and generates reports as needed. Provides guidance on engineering projects. Supports the internal and external quality audit program. Uses statistical tools to analyze data, make acceptance decisions, and improve process capability. Manages projects to completion.
General Duties and Responsibilities:
- Support daily manufacturing activities and work with Engineers to resolve line issues and implement corrective actions.
- Provide technical support for product inspections and lot release testing activities by working with cross functional teams to ensure product meet quality standards.
- Provide support and leadership to Product Improvement Teams as Quality Engineer.
- Manage customer complaint investigations from initiation through investigation and closure. Responsible for performing reportability assessments for complaints are completed in a timely manner.
- Responsible for effective root cause analysis and corrective action assessments.
- Manage NCMR investigations from initiation through investigation and closure. Perform product dispositions in a timely manner.
- 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.
- Manage and execute major quality projects which result in CPAR files and other Quality projects as assigned.
- Strive to constantly innovate and implement improvements for improved methods for testing components.
- Works under general supervision. Relies on instructions and pre-established guidelines to perform the functions of the job.
Qualifications:
- Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience.
- A minimum of 5 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.
- Must possess technical writing, project management and 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.