Senior Quality Engineering Technician

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.

Essential Job Duties & Responsibilities:

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.

Workstation Tasks:

• 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.

Additional Duties:

• 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.

Education Requirements:

• Associate degree in Electronics, or equivalent education and experience.

Physical & Environmental Requirements:

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.

Physical and Computer Tasks

• 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.