Quality Engineer

Job Description

Job Description

Position Title: Quality Engineer I FLSA: Exempt

GENERAL SUMMARY:

Responsible for establishing and achieving goals for quality, customer needs, business timeframes and manufacturability. Uses quality engineering methodologies and practices to meet D&R Products customer needs and regulatory requirements.

JOB RESPONSIBILITIES*:

• Use statistical techniques in order to comply with associated regulatory requirements and internal standards.
• Compile and analyze quality system metrics (e.g., management review, compliance metrics, product quality assurance) in order to ensure Key Process Indicators are identified, measured, and reported. Identifies unfavorable trends and drives proportionate action.
• Supports FDA 21CRF820/EU MDD, 13485 requirements by creating and reviewing customer’s design control deliverables.
• Proficient in reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gages, calipers, smart scope, pull test and other inspection equipment.
• Works with manufacturing engineering to ensure necessary process controls are in place and drive corrective and preventative action planning.
• Supports nonconforming events investigation, disposition and release activity.
• Assists with product transition from development to manufacturing by supporting the writing of protocols for IQ/OQ/PQ and establishing statistical standards of performance including support and familiarity in DOE, reliability strategy and analytical problem-solving techniques.
• Supports the development and execution of FMEA, Risk Analysis, Control Plans and FAI.
• Supports projects related to New Product Introduction / development.
• Write, review and / or approve quality plans to support product and process compliance activities.
• Supports CAPA, Complaints, NCPR activity.
• Able to work in a fast paced, privately held company with changing priorities.

· Contributes to team effort by accomplishing related results as needed.

OTHER DUTIES AND RESPONSIBILITIES

· Any other duties as assigned.

EDUCATION, SKILLS, COMPETENCIES, KNOWLEDGE, AUTHORITIES & ABILITIES:

· Bachelor of Science in Mechanical or Industrial Engineering.

· Minimum 2 years of experience as a Quality Engineer in the medical device industry.

· ASQ, CQE, CRE, CQA and/or Six Sigma Black Belt a plus.

· In depth knowledge of ISO 13485:2016

· Ability to present technical information.

· Ability to use inspection equipment such as optical comparators, calipers, micrometers, etc.

· Familiarity with use of SolidWorks.

· Proficient skills with excel, Microsoft word, Visio, and Minitab.

· Familiar with lean manufacturing.

· Depth of knowledge in one or more technical areas, statistical process control, root cause analysis, process optimization.

WORKING CONDITIONS/PHYSICAL DEMANDS:

Must be able to move throughout office and manufacturing space, using a complete variety of office equipment and manufacturing machinery and tools. Must be able to lift more than 50 pounds and stand for extended periods of time.

*The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.