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Quality Assurance Engineer II
2 months ago
Position Overview:
The Quality Assurance Engineer II will engage in the implementation and upkeep of quality assurance systems and methodologies in partnership with Agiliti manufacturing and design teams, ensuring compliance with internal standards, customer expectations, and regulatory guidelines.
KEY RESPONSIBILITIES
Conduct quality assurance activities for both new and existing products, as well as process enhancement initiatives.
Employ systematic problem-solving techniques and Statistical Process Control (SPC) methods to identify, prioritize, communicate, and resolve quality challenges.
Create and sustain product control plans, models, and inspection protocols for raw materials, in-process materials, and final products.
Work closely with Design, Manufacturing, and Supply Chain teams to assess supplier performance.
Analyze supplier performance metrics, identify trends, and collaboratively address any discrepancies or concerns with suppliers.
Participate in the planning, execution, and management of equipment validation processes (Installation Qualification, Operational Qualification, and Performance Qualification).
Engage in and potentially lead Material Review Boards (MRB) to support investigations and resolutions of product nonconformities.
Oversee review processes to maintain medical device documentation resulting from engineering change orders, including Risk Management, Process Failure Mode and Effects Analysis (FMEA), and Quality Control Plans.
Contribute to projects and cross-functional teams, with potential leadership of mid-scale projects.
Lead Corrective and Preventive Action (CAPA) investigations and implementation of action items.
QUALIFICATIONS
Bachelor's Degree (BS) in Engineering, Science, or a related technical field is required.
3-7 years of relevant experience, ideally in an ISO-regulated manufacturing setting.
Familiarity with Design Controls Management, including Design & Development Planning, Design Input, Design Output, Design Review, Design Verification & Validation, Design Transfer, Design Changes, and Design History File.
Experience with ISO 13485:2016 Medical Devices is preferred.
Knowledge of ISO 14971 Risk Management is advantageous but not mandatory.
Experience with metrology equipment and laboratory settings is preferred but not essential.
Experience in working with and qualifying automation equipment.
Proficiency in statistical analysis software for SPC and CPk Analysis.
Experience in tooling and fixturing qualification (First Article Inspection and Gage R&R).
SKILLS & COMPETENCIES
Electrical engineering background is preferred.
Bilingual in Spanish is a plus.
Proficient in MS Office Suite, including MS Project and Visio.
Working knowledge of CAD software is preferred (e.g., SolidWorks, Autodesk, etc.).
Strong analytical abilities and attention to detail.
Excellent technical writing and communication skills.
Effective presentation, facilitation, and project management capabilities.
This job description does not imply that these are the only duties to be performed by the employee in this role.
It is not intended to provide an exhaustive list of tasks or procedures for each responsibility.
The incumbent is expected to undertake additional duties necessary for the effective functioning of the department.Agiliti is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, veteran status, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. Agiliti will also provide reasonable accommodations for qualified individuals with disabilities.
