Quality Engineering Technician- Thurs- Sat 7:00Pm-7:00Am

Quality Assurance - QUALITY ENGINEER TECHNICIAN (HUGO 24/6 Shift)

Quality assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Quality Engineering Technician will be expected to provide support to Operations (Relative to Assigned Device Program 24_6 shift), interact with customers and provide support for Engineering, Quality Systems and Process engineering.

This position will be integral in meeting the HUGO Program Specific Requirements through compliance to the Quality Management System. It requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management and other appropriate procedures for a variety of medical devices in a sustaining position.

MAIN JOB RESPONSIBILITIES:

• Exhibits the Viant Medical Values in all activities
• Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.
• Actively participates ininternal audits (Gathering Shift Specific Support)
• (Relative to Assigned Device Program 24_6 shift) Acting as QC point of contact (as applicable) for 24_6 Shift needs

• • May perform visual and functional in-process, and final inspection of devices or labels.
  • Utilize mechanical and optical inspection equipment to measure components and devices to verify product meets specification.
  • Utilize quality procedures, specifications, work instructions, and associated documents in the performance of inspection duties.
  • Identify and process nonconforming material in accordance with established procedures.
  • Writing and preparing inspection reports regarding inspection and testing results

• (Relative to Assigned Device Program 24_6 shift) troubleshooting contact (as applicable) for 24_6 Shift needs
• Provide Site Production Support via QE (Technician Level) direction for Nonconformance's, Change Control and Release Activities
• Provide customer related quality and regulatory inquiries support
• Support and participate in implementation of continuous improvement projects/activities
• Support the Development and initiation of standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
• Facilitate execution of measurement system analyses under Engineering Direction to evaluate test and inspection equipment
• Supports disposition of discrepant material and devises process to assess product quality and reliability under Quality Engineering Direction
• Support for FDA and ISO inspections, audits, and registration
• Support and Participate in activities that increase the ratio of value added to non-value added processes
• Demonstrates willingness to learn and be agile under Engineering Direction through mentoring and responsiveness to business needs to achieve positive results
• Demonstrates Junior level technical ability through the application of Engineering Technician skills, approaches and knowledge

• • Provide quality assurance support within the organization as experience and time allow.

• All other duties as assigned

POSITION REQUIREMENTS:

Knowledge/Education:

• Associate Level degree in engineering, related technical or scientific discipline; or with exception related field with experience (to be considered: HUGO Specific Equipment, Design/Configuration, Quality Control)

Job Experience:

• 5-8 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility and QS knowledge
• Experience with FDA and ISO 13485 Certification inspections

Skills/Competencies:

• Strong written and verbal communication skills
• Ability to work well independently and also under direction of fellow team members
• Attention to detail and organization skills
• Computer skills with proficiency in Microsoft Outlook and Microsoft Office
• Exposure to Statistical Controls (Minitab, Excel, Capability Studies, Gage R&R, Etc.)
• Exposure to PLC Error clearing activities/decisions, etc.

Physical Requirements:

• Excellent vision and hand-eye coordination
• Periods of bending, lifting, and standing
• Significant use of hands
• Occasionally required to lift up to 50 lbs
• Must be able and willing to wear personal protective equipment as required including:

• Protective eyewear
• Protective gowning (Safety Shoes covers, Apron, Hairnet, gloves)

The Shift is specific based on A, B, C, or D defined by Production of HUGOand will remain flexible to best suit Quality Control and Quality Engineering Technician needs driven by Production demand.