Quality Engineer - MICRO MEDICAL SOLUTIONS, INC.

Job Summary:

The Quality Engineer is responsible for ensuring that the design, development, manufacturing in support of medical devices meet the requirements of 21 CFR Part 820, ISO 13485, the European Medical Device Directive (MDD) and the European Medical Device Regulation (MDR) and other applicable regulations and standards.

This position will be integral in meeting the Quality Management System requirements.  It requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management, and other appropriate procedures for medical devices from concept through market introduction.  

Primary Responsibilities:

• Lead manufacturing activities and actively participate in the development, qualification and validation of product/equipment and processes. Generate, lead, and/or review and approve process validation test protocols and reports and other associated process documents.
• Lead supplier qualification program which includes defining supplier requirements and generation of supplier qualification reports. 
• Conduct and lead assigned internal and supplier audits.  Issue and track non-conformities per MMS procedures.
• Lead, Review, and approve receiving inspection requirements and sampling plans for components. Develops and improves QC inspection and testing methods as needed.
• Actively participate in risk analysis activities (FEMA) on new development programs and ongoing risk management for products in production. Generate, lead, and/or review and approve risk management documents.
• Partner with engineering during the design and development process. Generate and/or review and approve test protocols, test method validations, test reports and other design control documents.
• Lead data collection, analysis, and trending for general QMS, management review, post market surveillance, etc. 
• Conduct investigation and root cause analysis for Corrective Actions and NCMR's.
• Complete CAPA and NCMR actions as assigned, ensuring timely completion. Verify accurate and complete records to allow for closure.
• Conduct and/or provide guidance to the engineering team with failure investigations related to customer complaints and oversees or implements corrective and preventive actions as necessary.
• Lead quality improvement projects that benefit the quality system, inspection, testing, assembly, or development of products.
• Generate, Review, and approve Engineering Change Orders.
• Assist with the maintenance of an ISO 13485, MDD/MDR and FDA QSR Compliant Quality Management System.
• Participate in and assist in preparation for 3rd party internal quality audits and external quality audits from Notified Bodies, FDA, etc.
• Keep abreast of changes to domestic and international regulations, standards, and guidance documents. Conduct impact assessments to new or revised standards or regulations and identify action plans related to QMS and product.
• Acts as subject matter expert for SPC, FMEA, DOE and process validation.
• Other duties as assigned.

Qualifications / Competencies:

• Preferred Education
  • B.S. degree in an engineering or other scientific discipline.
• Preferred Experience
  • 5+ years of recent experience in medical device industry, preferably with implants or stents.
  • Working knowledge of Quality System Standards (ISO 13485), FDA Regulation (21 CFR 820), European Regulations (MDD, MDR) and the Risk Management Process (ISO 14791).
  • Qualifications to perform internal or supplier audits.
  • Experience with FDA PMA submissions a plus.
• Other Desired Qualifications
  • Proficient technical writing skills and use of documentation programs (e.g., Office Windows, Excel, Access, Power Point, etc.).
  • Working knowledge of fundamental quality and statistical tools and software including SPC, DOE, Minitab, etc.
  • Excellent analytical and written and oral communication skills and the ability to manage a variety of tasks simultaneously within cross-functional teams under minimal day-to-day supervision.
  • Must be able to identify and recommend effective solutions to problems, utilizing technical problem-solving tools, working individually and with others within and outside the quality function.
  • Must have capability to review, analyze, summarize, and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
  • Must be able to manage multiple projects and report progress against goals in an objective manner.
  • Strong organizational, analytical, and time-management skills.
  • Able to self-motivate and work both independently and as part of a team.
  • Proficient in knowledge of a variety of testing equipment (including Instron, pin gages, snap gages, micrometer, caliper, etc.).
  • ASQ, or equivalent, Quality Engineering certification and/or ISO 13485 Lead Auditor Certification a plus.

Physical Requirements:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Prolonged periods sitting at a desk and working on a computer.
• While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.