Quality Engineer Sr I

Main Objective

Responsible for various Quality Assurance functions for manufacturing development of medical devices in achievement of company goals.

Essential Duties And Responsibilities

• Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development project teams.
• Participates in all manufacturing activities to assure compliance of design specifications.
• Leads development of quality plans of new product introductions based on design specifications, PFMEA, and control plans.
• Works with design team and assist/provide feedback on design specifications and improvements.
• Evaluates and develops effective and efficient methods of testing and inspection of products.
• Utilizes problem solving tools and techniques and apply risk based approach to problem solving.
• Determines necessity of testing and initiates testing by preparing test and inspection plans and identifying and obtaining required test fixtures and test/inspection instrumentation.
• Initiates new projects and acts as the project leader for key initiatives, identifies best practices.
• Provides technical support on manufacturing technical issues.
• Performs quality trending and leads/supports process improvement initiatives.
• Approves manufacturing product and process changes and assures the change management is controlled, adequate, and documented.
• Ensures information and documentation is consistently accurate.
• Supports manufacturing suppliers with assistance in on-site resolution of quality and process related issues and corrective and preventive actions.
• May supervise other engineers, technicians, and support personnel.

Education And Experience

• Bachelor’s degree required in an Engineering or Engineering Technology discipline.
• 5 years experience in a Quality Control or Quality Assurance position required, preferably in a medical device company.

Knowledge And Skill Requirements/Specialized Courses And/or Training

• Working knowledge of risk assessments, design control requirements, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques.
• Mechanical, Tools, and/or Equipment Skills: Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software.

Reasoning Ability

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Mathematical Skills: Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
• Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The area that this job is performed in is a general office or open cubicle/workstation environment.
• The noise level in the work environment is usually moderate.