What are the responsibilities and job description for the Senior Quality Engineering Technician position at Altivera Medical?
Job Details
Description
Competencies Needed:
Main Daily Duties:
Administrative Tasks
Workstation Intensive Tasks
Description
Competencies Needed:
- Adaptability: Deals with ambiguity well; adjusts to changes in a productive, professional manner.
- Customer-Focus - Implements ways to rapidly respond to customer requests for improved outcomes; works with the customer to collect accurate information about needs; goes beyond the initial thinking and remains flexible to meet customer needs; maintains strong and loyal customer relationships. In addition to patients, your customers may be coworkers, clinics, the Altivera Medical sales team, etc.
- Attention to Detail: Does not miss important details even when busy; works with precision, able to attend to multiple items at a time without increased errors.
- Analytical Problem Solving: Gathers information to solve problems, is able to see root causes and address these as needed.
- Decision Making: Decisive and gather information to ensure proper decisions are being make; uses objective process for decisions; Results Orientation.
- Organization & Time Management: Effectively prioritizes plans and works in an efficient manner.
- Team Player: Prioritizes team over self; works well with peers and management; able to compromise when best for the company.
- Communication: Communicates clearly 1:1 with coworkers; proactive to make sure others are informed when needed; gives and receives feedback constructively.
Main Daily Duties:
Administrative Tasks
- Provide support to the Quality Assurance, Production, and Engineering teams.
- Updates and edits manufacturing work instructions, drawings, and SOPs.
- Writes Engineering Change Orders, CAPAs, and other quality documentation.
- Facilitate internal and external audits to meet regulatory standards.
- Assists Quality Assurance, Engineering and Production with various projects.
- Assists with reviewing and investigating product complaints for all Altivera Medical Medical products.
- Assists with determining and filing any required Medical Device Reports (MDRs) with the FDA
- Provides data on trending for all non-conformance reports.
- Ensures all quality records are kept in an organized and easy to retrieve manner.
- Maintain medical device records and documentation.
- Tests, troubleshoots, and repairs all Altivera Medical products.
- Assists Test and Service technicians with troubleshooting.
- Builds test fixtures, tooling, and other items to assist with manufacturing of products.
- Assembles projects as directed by Quality Assurance, Engineering and Production teams.
- Runs Validation and Verification testing, as required.
- Functions with a minimal amount of supervision.
- Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Be present/visible in the home office 5 days/week (M-F), 8 hours/day. Exceptions to this need prior approval from your direct Manager.
- Performs other duties as assigned by Engineering, Production Managers or CEO.
- Associate degree in Electronics, or equivalent education and experience.
Workstation Intensive Tasks
- Communication: Effectively communicate via spoken, written, virtual, and electronic means.
- Dynamic Warehouse Environment: Operate in a fast-paced, professional warehouse setting.
- Ergonomics: Maintain proper posture using company supplied equipment.
- Operating Tools: Proficiently perform repetitive tasks using hand tools, necessitating manual dexterity, hand-eye coordination, and a keen attention to detail.
- Sitting for Extended Periods: Sit for prolonged periods while working on a computer.
- Strenuous Eye Activities: Ability to focus and concentrate on detailed tasks for extended periods to reduce eye strain. Including: close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
- Technology Proficiency: Utilize office equipment, including computers, copiers, fax machines, and telephones, as well as demonstrate proficiency in Microsoft Office Software.
- Heavy Lifting: Lift objects weighing up to 40 lbs.
- Operating Machinery: Proficiently perform repetitive tasks using machinery, necessitating manual dexterity, hand-eye coordination, and a keen attention to detail.