Quality Engineer

Description

Job Description Quality Engineer with at least a Bachelor's Degree in Engineering along with an ASQ Certified Quality Engineering (CQE) and atleast 4+ years of work experience in Medical Device industry.
Quality Engineer will be responsible for providing Quality Engineering support as a member of the crossfunctional team responsible for manufacturing operations.
This role supports the production of surgical sutures, and polymerbased components for endoscopic and stapling surgical instruments.
Primary Skills Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet
required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Provide Quality Engineering support as a Process Validation team member and lead/execute Test Method Validations and Measurement Systems Analysis (MSA).
Work directly with component/raw material suppliers and Incoming Quality to include inspection plan creation and maintenance, PPAP (as applicable), and SCAR/NCR management.
Process Validation and/or Root Cause Analysis experience
Working knowledge of statistical methods and applications (Minitab experience a plus)
Project management experience (familiarity with Microsoft Project Gantt Charts).
Familiarity with Lab operations/management.
Must Have Skills ASQ Certified Quality Engineering (CQE)
Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints
Support reliability activities for new product development. Drive for root cause understanding and corrective action implementation to ensure
product meets reliability requirements.
Strong written and verbal communications (including presentation skills)
Proficiency in Microsoft Project, Word and Minitab