BASIC SCOPE:
The QA Engineer will advise Management on quality planning (both short term and long term) supporting and providing diagnosis of quality problems (both internal and external), corrective and preventive action (CAPA) programs and continuous improvement programs for the Company’s mechanical and electro-mechanical medical products. Develop, validate, document and refine QA Test and Inspection procedures. Identify nonconformance trends, develop, and administer technical investigation and corrective action programs to resolve recurring internal and external opportunities to improve overall quality performances. Provide quality reporting on product, process and performances.

ESSENTIAL JOB FUNCTIONS:
α Supports company goals and objectives, policies and procedures, QSR, FDA, Medical Device Directives, international standards and any other applicable regulations.
α Defines deliverable quality requirements for R&D project plans. Utilizes extensive knowledge and experience in quality compliance and technical engineering knowledge to support the projects and achieve the business goals.  May lead project teams.
α Develop Process Validation Master Plans and IQ, OQ, PQ, PPQ Protocols.
α Provides Quality Assurance input and guidance during manufacturing, production and design activities in support of new product introductions and modifications to existing products.
α Participates in determining goals and objectives for projects, maintains schedule for specific aspects of a project; identifies problems and recommends solutions to multiple aspects of a project.
α Utilizes standard statistical analysis techniques to determine product acceptance: evaluates process capabilities; and develops statistically sound tolerance limits based on product specifications.
α Evaluate and recommend sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment.
α Define sampling plans with statistical rationales and/or process control plans to manufacturing applications
α Establishes inspection methods and appropriate inspection plans for raw materials, materials in process,  finished qoods, and new product introduction.
α Provides assistance and/or performs inspection, electrical safety testing and review of conforming and non-conforming product
α Leads and/or participates in the training of assemblers and inspectors, in the implementation of solutions.
α Chairs Material Review Board (MRB) meetings for review of non-conforming materials.
α Prepares Vendor QA/Inspection protocols.  Participates in vendor site audits and work with suppliers to improve quality of both delivered parts and internal quality processes.
α Maintains frequent intra- and inter-organizational and external customer contacts.
α Selects and acquires equipment/tooling as required.
α Communicates progress of projects to upper management.
α Implements lean and six sigma principles and practices throughout the organization to enhance overall company performance
α Interacts within the Engineering Change system to revise and/or create technical drawings.
α Researches and recommends cost effective and/or strategic integration strategies.
α Performs tests, gathers and documents data for engineering and quality assurance programs and projects

PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Duties are performed while sitting at a desk for long periods of time. Required duties include operating a computer, reading, writing and using a telephone. Walking or standing within the office area may be required for the operation of office equipment and for attending meetings.
The duties of this job require the employee to sit, to use hands to manipulate very small objects and hand tools for periods of time.  The employee is occasionally required to stand, walk and lift 50 pounds during the normal course of work. Specific vision abilities required by this job include close vision. 
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Job duties are performed in an office environment utilizing standard office equipment such as a computer, photocopier, and telephone.  The noise level in the work environment is usually low to moderate.
Within the Assembly area the employee may be exposed to sharp objects, small tools, hot objects, adhesives, various testing equipment, etc.  The noise level in the work environment is usually low to moderate.
Equipment in the machine shop may include, drills press, lathes, band saws, grinders, welding equipment, mills, etc.   Sound levels may be moderate to high.

KNOWLEDGE, SKILLS AND ABILITIES
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required. More senior levels require increasing breadth and depth of knowledge as described below.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Demonstrated excellent verbal as well as written communication skills. Ability to write clearly in a variety of formats, such as procedures, processes, procedures and reports, applying correct English grammar and style.
2. Experience handling complaints and CAPA implementation
3. Team oriented and personally committed to continuous improvement
4. Familiarity with “lean” manufacturing and six sigma methods and principles
5. Demonstrated ability to interface effectively and positively throughout organization, suppliers & customers.
6. Demonstrated knowledge of engineering applications, CAD and Solid Modeling software
7. Demonstrated knowledge of computer applications for reports, spreadsheets and statistical analysis
8. General understanding of Geometric Dimensioning and Tolerance (GD&T) skills
9. Ability to operate and produce basic to complex inspection programs for the CMM and Optical Comparator

Minimum Education Requirements and Experience

Bachelor's Degree  & 2-5 YOE

Please email resume for consideration to Yvonne Robles, This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .