Quality Engineer

This is an opportunity to be part of the Quality Engineering function for one of the most innovative and advanced medical device manufacturing companies in the business. We are experiencing tremendous growth, even during a down market and are looking to build the quality team via this addition to the staff.

Position: The Quality Engineer applies best practices from within the field of quality control to ensure that the materials, components, processes, and manufacturing techniques used produce high quality and reliable products.

Nature of Role: Reporting to the Director, Quality Services, this ‘go-to’ resource stays abreast of current quality and regulatory trends and ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.

Minimum Requirements: A Bachelor degree in a scientific or engineering field with experience in a quality engineering role in the medical, electronics packaging, high reliability, or a related industry with manufacturing & assembly processes. The following key attributes are required:

• Previous experience with manufacturing and assembly processes is required

• Strong written and verbal communication skills are required, including proficiency with standard office productivity suite and data analysis software
• ISO Lead Auditor training is preferred
• ASQ CQE preferred
• High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability, etc.
• Experience with design review and design control
• Experience with FDA GMP practices, CAPA and non-conforming materials (NCMR) processes
• A working understanding of FDA Quality System regulations, EU Active Implantable & Medical Device Directives, and ISO 13485 principles

Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:

• Successful communication skills, business acumen and assertive decision-making ability
• Flexibility to multi-task and perform a wide range of activities
• Excellent computer skills, including MS Office proficiency
• Self-motivated and capable of working with minimal supervision

Key Responsibilities:

• Plans, executes or directs activities concerned with development, application, and maintenance of quality standards. Reports results to marketing, manufacturing, process engineering, and product design groups
• Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as electrical, or mechanical
• Establishes programs to evaluate analytical testing, equipment, facilities, precision measurements, accuracy measurements, and performance testing
• Provide technical guidance to Quality Engineers, Quality Technicians, and Quality Inspectors
• Lead or assist in quality evaluation of returned products and support RMA program
• Lead, participate in, or coordinate Internal Corrective Action initiatives
• Participates in the technical review of design input specifications and design documentation for new medical devices
• Participates in the development of system specifications
• Plans, develops, and executes verification testing for products under development
• Performs internal quality and design control audits
• Performs product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA)
• Takes an active role to ensure products meet corporate, industry, and regulatory standards
• Assists management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements
• Develops, documents, and validates inspection and test methods to support design control, in-process inspection, and final inspection activities
• Develops manufacturing control plans for internal and outsourced processes
• Completes component part qualification activities including first articles, cap studies, gage R&R, and implementation of SPC requirements
• Supports product/process transfers during pilot and manufacturing builds
• Conducts design for manufacturability reviews and suggests improvements to aid in capability and measurement analysis

Qualified candidates should send a cover letter and resume to hrmgr@ximedica.com