Quality Engineer

Department: Engineering | Reports To: Director of Regulatory Affairs | FLSA Status: Exempt

About the Role

Develop, implement, maintain and support activities for quality improvement and manufacturing programs. Support the CAPA program and address customer complaints.

Responsibilities

• Product testing and evaluation
• Maintain employee training
• Annual sterilization testing
• Lead product quality investigations to a successful conclusion
• Execute risk assessments, collect supporting information and provide recommendations for management consideration
• Interface with other departments to provide guidance on CAPA completion
• Provide technical guidance to QA and QC personnel
• Represent quality interests and concerns on project teams
• Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements
• Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection
• Collect, analyze, trend and communicate quality data throughout the organization
• Identify and help facilitate continuous improvement, corrective and preventive actions
• Serve as a resource in Engineering Change Order review process
• Mentor, educate and train QA personnel
• Assume additional responsibilities as necessary at the discretion of QA
• Develop programs and methodologies for analyzing and presenting quality system data
• Identify program opportunities for improvement and drive procedure updates when required
• Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements

Requirements

• Four-year degree, preferably in a technical discipline
• 3-5 years related experience in a regulated environment, preferably medical device
• Proficiency with MS Office
• Familiarity with use of mechanical and electrical test equipment
• Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing
• Ability to analyze and aggregate data using statistics
• Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices (preferred)

Skills

• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures and/or governmental regulations
• Ability to write reports, business correspondence and/or procedure manuals
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, vendors, non-engineers and/or the general public
• Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume
• Ability to apply concepts of basic algebra and geometry
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• Knowledge of modern business communication, office procedures and methods
• Skill to use a personal computer and various software packages such as Microsoft Office Suite
• Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork

Essential Job Functions

• Mental: Must be able to effectively communicate with others; complete and understand complex analysis of numbers; read, analyze and interpret written materials; meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems.
• Physical: Must be able to hear and verbally communicate for hours at a time, use computer equipment, electrical and general hand tools. Moderate noise level and limited exposure to physical risk.

Certificates, Licenses, Registrations

• Maintains a valid Driver’s License.

Equipment Used

• Telephones, computer, other office equipment as needed, electrical and general hand tools.

Persons in this position may be required to pass a drug, alcohol, and/or criminal background check.