Quality Engineer

Applied Medical Technology•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, while helping ensure that manufacturing, new product development, and regulatory systems comply with internal and external requirements. The position reports to the Director of Regulatory Affairs and does not supervise others. The Quality Engineer investigates product and process quality concerns, performs product testing and evaluations, supports annual sterilization testing, and conducts risk assessments. The role collects, analyzes, trends, and communicates quality data; recommends improvements; supports procedure updates; and provides technical guidance and training to quality personnel. The position also represents quality on project teams and contributes to engineering change reviews. The work requires communication, analytical, statistical, and problem-solving skills, along with the ability to interpret technical and regulatory materials. The role uses computers, office equipment, and electrical and general hand tools. A valid driver’s license is required. A drug, alcohol, and/or criminal background check may be required.

Requirements

Four-year degree, preferably in a technical discipline.
3–5 years of related experience in a regulated environment, preferably medical device.
Proficiency with MS 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.
Valid driver’s license.
Ability to read, analyze, and interpret business and technical materials and governmental regulations.
Ability to write reports, business correspondence, and procedure manuals, and present information effectively to varied audiences.
Mathematical ability, including working with proportions, percentages, basic algebra and geometry, probability, and statistical inference.
Ability to solve practical problems, interpret written, oral, diagram, or schedule instructions, define problems, collect data, establish facts, and draw valid conclusions.
Ability to communicate effectively, analyze numerical information, interpret written materials, meet company standards, ensure policy compliance, respond to feedback, maintain positive working relationships, and troubleshoot problems.
Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork.
Ability to hear and verbally communicate for hours at a time and use computer equipment, electrical tools, and general hand tools.

Nice To Haves

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

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 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 activities to ensure systems comply with 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.
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 improvement opportunities and drive procedure updates when required.
Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, GMP, ISO, and FDA requirements.