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.
Assists 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.
Assists 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

• Bachelors 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. Must work responsibly with or without supervision using effective communication skills; able to collaborate with various departments and all levels of team members.

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.

Managing Responsibilities
No direct reports.

Required Experience:

IC