Job Description

Job Title: Quality Engineer
Department: Engineering
Director of Regulatory Affairs
Exempt
Supervise the work of others: No

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

Duties and Responsibilities:

This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties will be required and/or assigned.

• 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
• Resource in Engineering Change Order review process
• Mentoring, education and training of 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

Supervisory Responsibilities: None

Minimum Qualifications:

• 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 preferred with ISO 13485, ISO 14971 and FDA QSR for Medical Devices

Language 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.

Mathematical Skills:

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.

Reasoning Ability:

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.

Certificates, Licenses, Registrations:

Maintains a valid Driver’s License.

Essential Job Functions Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons.

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.

Knowledge, Skills, and Abilities Required 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.

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

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

AMT is Equal Opportunity/Affirmative Action Employer

Requirements

Minimum Qualifications:

• 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 preferred with ISO 13485, ISO 14971 and FDA QSR for Medical Devices