Quality Engineer
POSITION SUMMARY:
The Quality Engineer serves as the primary quality representative supporting manufacturing operations and product lifecycle management. This position will work closely with AtriCure Engineering, Manufacturing, Regulatory, and Supplier Quality to ensure manufacturing product quality, risk management, continuous improvement, and regulatory compliance of AtriCure products and processes. This individual will have a technical foundation and must be able to lead and coordinate activities related to daily operations.
ESSENTIAL FUNCTIONS OF THE POSITION:
Provides daily Quality Engineering support of manufacturing operations where daily activities require working with collaborative cross-functional teams. Daily tasks require the timely addressing of product line issues through correction and prevention processes.
With respect to direct line responsibility, the QE manages, and coordinates required activities from functions (ie. Engineering, Manufacturing, Supplier Quality, Inspection, Document Control) and processes (ie. NCR, Investigation, FMEAs, Rework, Deviations, CAPA)
Chairs the MRB for respective product line.
Leads and/or supports risk management activities including risk assessments, pFMEAs, health hazard evaluations, and implementation of risk control measures throughout the product lifecycle.
Analyzes quality metrics, manufacturing trends, and process performance indicators to identify risks and drive improvement initiatives with cross-functional peers.
Contributes to new product development and transfer by supporting Design Assurance (and NPD Teams) as required. Examples would include inspection/control plan development and the establishment of compliant production and process controls during production transfer
Leads and/or supports protocol development, execution, review and approval activities for process validation, equipment qualification, test method validation, and manufacturing line transfers.
Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.
Assists with 3rd party, internal, and external FDA and ISO audits, as necessary
Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with little guidance from management, and resolves problems/conflicts.
Performs other duties as assigned
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Regular and predictable work performance
Ability to work under fast-paced conditions
Ability to make decisions and use good judgment
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
BASIC QUALIFICATIONS:
Bachelor’s degree required in Engineering or demonstrated equivalent combination of education, training and experience.
2 - 5 years of experience in a process, manufacturing, or quality engineering role.
Able to interpret design drawings (including GD&T) and product specifications
Measurement System Analysis (Gage R&R) experience a plus
Experience with process validation, design verification/design validation
Problem solving/Troubleshooting experience
Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kaizen, etc. a plus
Strong interpersonal, organizational, and communication skills.
FDA and ISO 13485 knowledge
Metrology, auditing and data analysis experience
Computer/data entry skills
Written/report writing skills
Experience training production associates, inspectors, or junior engineers.
Experience with industrial or manufacturing statistics
PREFERRED QUALIFICATIONS:
Experience as a quality or manufacturing engineer at a medical device company
MDD, MDR, CMDR and JPAL knowledge
Regulatory experience
Experience with design verification / design validation
Knowledge of EO and Gamma sterilization processes.
Engineering/design background
OTHER REQUIREMENTS:
Ability to regularly walk, sit, or stand as needed
Ability to occasionally bend and push/pull as needed
Ability to pass pre-employment drug screen and background check
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