Quality Engineer

Applied Medical Technology Inc.•Brecksville, OH

About The Position

The Quality Engineer develops, implements, maintains, and supports quality improvement and manufacturing programs. The role supports the CAPA program and addresses customer complaints. It works with engineering, quality, manufacturing, new product development, and regulatory teams to help ensure systems comply with internal and external requirements. The position reports to the Director of Regulatory Affairs and has no supervisory responsibilities. The role includes product testing and evaluation, product quality investigations, risk assessments, quality-data analysis and communication, and support for the Engineering Change Order review process. It also provides guidance and training to QA and QC personnel, maintains employee training, and supports annual sterilization testing. The engineer identifies improvement opportunities and helps update procedures as needed, while adhering to quality-system SOPs, work instructions, drawings, Good Manufacturing Practices, ISO, and FDA requirements. The position requires a four-year degree, preferably in a technical discipline, and 3–5 years of related experience in a regulated environment, preferably medical device. It also requires proficiency with Microsoft Office, familiarity with mechanical and electrical test equipment, knowledge of medical-device manufacturing practices, and the ability to analyze and aggregate data using statistics. A valid driver’s license must be maintained. The job involves computer use, electrical and general hand tools, and communication and analytical work; the environment has moderate noise and limited exposure to physical risk.

Requirements

Four-year degree, preferably in a technical discipline.
3–5 years of related experience in a regulated environment, preferably medical device.
Proficiency with Microsoft Office.
Familiarity with 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.
Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, and governmental regulations.
Ability to write reports, business correspondence, and procedure manuals, and present information effectively to varied audiences.
Ability to perform calculations involving proportions, percentages, area, circumference, and volume; apply basic algebra and geometry; and work with probability and statistical inference.
Ability to solve practical problems, interpret written, oral, diagrammatic, or schedule-based instructions, define problems, collect data, establish facts, and draw valid conclusions.
Ability to communicate effectively, complete and understand complex numerical analysis, interpret written materials, comply with company policies and standards, respond appropriately to feedback, maintain positive working relationships, and troubleshoot and solve problems.
Knowledge of modern business communication, office procedures, and methods.
Ability to use a personal computer and software packages such as Microsoft Office Suite.
Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork.
Maintain a valid driver’s license.
May be required to pass a drug, alcohol, and/or criminal background check.

Nice To Haves

Experience with ISO 13485, ISO 14971, and FDA QSR for medical devices is preferred.

Responsibilities

Develop, implement, maintain, and support quality improvement and manufacturing programs.
Support the CAPA program and address customer complaints.
Perform product testing and evaluation.
Maintain employee training and conduct mentoring, education, and training for QA personnel.
Conduct annual sterilization testing.
Lead product quality investigations through 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 teams to help ensure systems meet 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 and corrective and preventive actions.
Serve as a resource in the Engineering Change Order review process.
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, ISO, and FDA requirements.
Assume additional responsibilities as necessary at the discretion of QA.