Our well established and thriving Austin client with an international presence has a need for a Senior Metrology Quality Engineer to join their dynamic organization. The Sr. Metrology Quality Engineer is primarily responsible for developing and implementing component, subassembly and device-level incoming and final inspection methods along with documentation responsibilities in accordance with our client's Quality System to ensure that all components meet specifications. Additionally, the Sr. Metrology Quality Engineer provides overall QE support for new product development, manufacturing transfer and sustaining product updates.
SPECIFIC JOB DUTIES:
- Implement quality strategies and policies, ensuring compliance with regulations while promoting recognition of our client's programs among internal and external partners.
- Ensure compliance with both organizational objectives and relevant regulatory requirements including US FDA Quality System Regulation (QSR)/Good Manufacturing Practices (GMP), ISO 13485, European Medical Device Directive (MDD), European Union Medical Device Regulation of 2017 (EU MDR) and our Quality Manual.
- Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components, devices and/ or production or test equipment.
- Utilize drawings, specifications, industry standards, and sketches, adapting inspection measuring devices and procedures when necessary; read and interpret technical drawings and specification requirements.
- Perform and analyze capability studies, GR&R’s, FAI reports on components in development phase.
- Lead and conduct engineering quality activities such as product verification, design and process validation, failure analysis, risk and hazard analyses, authoring test plans and reports, developing and implementing quality inspections, determining sample sizes and Design of Experiments (DOE).
- Actively participate in the review of engineering specifications to assure that adequate quality assurance requirements are met proactively and designs are adequately transferred into manufacturing with high process capability measured against critical requirements.
- Act as Quality lead and driver of design controls on continuous improvement and new product development project teams to ensure adherence to design control requirements, review drawings for adherence to design inputs; material callouts and standards and procedures; and regulatory and QS requirements.
- Collaborate with internal partners including engineering, operations, sales/marketing and external partners on new product development as well as proposed changes to products and manufacturing processes.
- Assess current practices within supply chain against regulations, standards, external guidance and our requirements; recommend action as appropriate.
- Identify and implement methods to drive sustainable manufacturing including initial process development and improvements, inspection and testing, equipment, tools and fixtures.
- Author, review and approve documents such as memorandums, protocols and reports to support regulatory submissions.
- Provide quality input and at times serve as lead quality contact for quality system assessments, non-conforming material evaluations, corrective and preventive actions, advertising and promotional activities, recalls and field actions, complaints/MDR/Vigilance, as well as other post marketing surveillance systems.
- Identify quality-related training needs; ensure workers performing quality inspections of our product have received training, and training-related goals and objectives are met.
- Support Quality System audits including internal audits and those conducted by FDA, Notified Body and other regulatory agencies, as needed.
- Support our Quality Policy and Quality System.
- Additional responsibilities related to quality and/or regulatory as assigned.
BASIC SKILLS/EDUCATION/EXPERIENCE REQUIREMENTS:
- Minimum 5 years of experience in the medical device industry, Class II or III devices.
- Experience in FDA QSR/GMP, ISO 13485, and MDD and awareness of EU MDR.
- Advanced knowledge and ability to interpret Geometric Dimensioning & Tolerancing (GD&T).
- Advanced knowledge of micrometers, calipers, indicators, comparators and force testers.
- Advanced knowledge of physical and dimensional inspection dimension methods.
- Working knowledge of design controls, environmental monitoring, biocompatibility, shelf life/accelerated aging, verification and validation.
- Demonstrated ability to make decisions related to product quality and release of product.
- Excellent interpersonal skills and ability to work well in a team environment.
- Excellent technical writer; demonstrated ability to write protocols, reports, and internal memos to support product regulatory submissions and audits.
- Experience to providing and implementing solutions to quality problems
- Strong working knowledge of statistics.
- Ability to travel occasionally, if required, to meet business needs (domestic and/or international).
- B.S. in Mechanical Engineering or related engineering discipline preferred.
- B.S. in Engineering; Biomedical Engineering and Mechanical Engineering are preferred Engineering disciplines
- Quality Engineering experience with implants, endoscopic and laparoscopic devices
- ASQ Certified Quality Engineer (CQE)
- Working knowledge of machine shop technology, electropolishing, ultrasonic welding, laser cutting, passivation, and clean room technology
- Working knowledge of packaging requirements
- Experience in an outsourced OEM environment; experience with contract or virtual manufacturing
- Working knowledge of OGP Measurement Systems and/or Keyence Vision System
Materials & Equipment:
- Microsoft Office, statistical software (e.g. Minitab or JASP)
- Test equipment (e.g. micrometer, caliper, pin gauge)
- Visual inspection systems (e.g. CMM/Coordinate Measure Machine, optical comparator)