Quality Technician II - 1st Shift

Quality Technician II - 1st Shift

Onsite Location: Maple Grove, MN, US, 55311

1st Shift: 5:30 am - 1:30 pm

About the Role:

This position is expected to provide day-to-day onsite floor support for the production team to address Quality problems and questions. This role requires cross-functional collaboration across Production, Manufacturing and Quality to develop, apply, monitor, improve and communicate Quality events. This role requires the individual to drive continuous improvement within product quality and compliance as well as the ownership and reporting of nonconformance. This position requires critical and creative thinking to perform investigations to resolve problems that arise on the production floor.

Your Responsibilities Will Include:

• Provide Quality floor support to the Production Team.
• Perform project and product testing.
• Lead and assist Engineers in Failure Investigations associated with Nonconformance and CAPA Activities.
• Document and own nonconforming events associated with material, designs and/or systems which may include: containment of impacted material(s), failure investigation, dispositioning of material, risk assessment evaluation and corrections.
• Participate in continuous improvement projects.
• Assist with quality issues and quality metrics related activities.
• Assist with product failure analysis.
• Perform testing, gather data, and analyze results of product testing and process monitoring.
• May assist with audit-related activities.
• Assist with CAPA activities.
• Assist in creating, validating, and maintaining data files and forms.
• Use documentation systems to research information and generate Change Notifications and/or Process Change Analysis Requests.
• Assist in developing and qualifying test methods, data sheets, test fixtures, and testing equipment.
• Review device history records (DHR) and acceptance records to ensure all activities in the Device Master Record (DMR) have been performed and approved.
• Update and maintain databases and spreadsheets used to track, monitor, and report department activities.
• Use the inventory and traceability management systems to transact and research material.
• Communicate with a wide variety of BSC personnel in and outside of the plant.

Required Qualifications:

• 2 years of experience with a High school diploma/degree/equivalent work experience

Preferred Qualifications:

• AA degree or Higher
• Experience in the medical device field in a quality role
• Experience in MES, SAP or equivalent MRP system
• Lean manufacturing experience
• Workstation error proofing experience
• Proficient in Microsoft office (Excel, Word, PowerPoint, OneNote, etc.)
• Strong written and verbal communication skills
• Must work well in a team environment
• Technical background with a passion for continuous improvement
• Ensure compliance with company policies and procedures
• Self-motivated individual with a drive to succeed