Quality Engineer II

Primary Responsibilities

• Self-starter, working independently on assigned projects, leading the team and collaborating with other internal and external parties.
• Plans, coordinates, and directs quality control programs designed to ensure continuous production of products consistent with established FDA and ISO standards.
• Investigates and addresses customer complaints (CAPA) regarding quality.
• Affords assistance with internal/external audits of the Quality Management System (QMS) to ensure compliance to procedural, customer, and regulatory requirements.
• Fully versed in Document Control processes and procedures.
• Affords assistance in reviewing and revising processes within the QMS (Quality Management System).
• Provides inspection activity for products throughout the production cycle.
• Creates, implements, updates and maintains work instructions, partnering with the Engineering and other departments.
• Creates and directs process/equipment validations (IQ, OQ, PQ).
• Reviews customer contracts (purchase orders, regulatory requirements, blueprints).
• Creates PPAP documentation (GR&R, control plans, first article inspection, criteria, etc.).
• Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.
• Trains quality and other departments to achieve quality standards (visual and dimensional).
• Works with suppliers to ensure quality of all purchased parts for company use.
• Helps reduce scrap/waste, cost, time; drives for continuous improvement.
• Reliable, timely, ethical and consistent attendance.
• Travels to another facility and/or customer/vendor sites based on company needs.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or a related field preferred or equivalent experience
• five to seven years of experience in medical device manufacturing industry and in the quality engineering role, and/or training, or equivalent combination of education and experience
• Knowledge of the medical device manufacturing industry is highly preferred.
• Experience with CNC machining and mechanical inspection is preferred.
• Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.
• Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.
• Familiarity with test methods and standards for the design, verification, and validation of medical device products.

Language Ability

• Ability to read, analyze, and interpret common scientific and technical manuals, training materials, financial reports, and legal documents (specifically in English).
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community (specifically in English).
• Ability to communicate effectively with tact, respect and professionalism within all levels of the organization.

Computer Skills

• To perform this job successfully, an individual should have professional and working knowledge of Microsoft office and its applications (Word, Excel, Power Point, etc.), e-mail, communication platforms (Zoom, Teams).
• Knowledge of manufacturing software and ERP systems (EPICOR is strongly preferred).

Certificates and Licenses

• No certifications required.
• Relevant certifications demonstrating applied understanding of medical device quality system requirements, such as AAMI Quality System, Certified ASQ or ISO Lead Auditor and Regulatory Affairs Professional Society (RAPS) preferred.
• GD&T certifications are highly preferred.