Quality Engineer II (Must have Medical Device Manufacturing experience)

Note: Only candidates with Medical Device Manufacturing experience  will be considered. 

Quality Engineer II is responsible for initiating and leading continuous improvement projects and new product introductions.  This role will coordinate and verify quality standards in accordance with the requirements of the organization. You will actively participate in quality improvement endeavors while working collaboratively and cohesively with employees to resolve issues, applying the requirements to our processes, products or services, and ensure compliance to applicable laws, regulations and standards.

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

• High School Diploma or equivalent,
• and 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

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.