Quality Assurance & CAPA Analyst

BD; Columbus (NE); On-site; USD 52,000 - 82,000; Full time

Benefits offered by this job

DailyPay access

Healthcare coverage

Paid parental leave

401(k) match

Tuition reimbursement

Vacation

Job summary

BD is seeking a Quality Assurance professional at its Columbus, NE Molding Center to generate quality notifications, perform risk assessments, and drive CAPA activities. The role requires inspecting processes, applying sampling plans, and collaborating with manufacturing staff to sustain cGMP compliance.

The candidate should have 3–5 years of manufacturing QA experience or an Associate’s in QA, with proficiency in SAP, Trackwise, and data analysis tools like Excel/Minitab.

Qualifications

• Required: HSD/GED
• Preferred: Associates Degree – Quality Assurance/ related field
• 3-5 years manufacturing experience required, or associate’s degree in quality assurance or related field.
• Quality System knowledge and/or experience preferred.
• Use of measurement devices and quality records preferred.

Responsibilities

• Generate and update Quality Notifications and initiate risk assessments and root cause investigations.
• Establish product containment regarding non-conforming material.
• Apply and interpret ANSI/ASQ Z1.4 and other sampling plans, monitor reinspection and perform statistical sampling as required
• Perform statistical data analysis (Excel, Minitab)
• Provide CAPA Support
• Proficient with software systems (SAP, Trackwise, Prolink, etc.)
• Support product complaint investigations and corrective actions.
• Provide guidance and input to manufacturing and management for quality issues.
• Contribute with continuous improvement activities (i.e. Kaizens, Blitzes, Validations, etc.) and conduct machine and process capability studies on equipment.
• Trend quality metrics and investigate specific problem areas in manufacturing and report findings or corrective actions as required.
• Conduct proper filing of documentation and react to urgent matters responsibly.
• Must be familiar with specifications and documentation associated with operations.
• Comply with plant cGMP and department protective clothing, safety, and management policies.
• Must be familiar with the quality policy and procedures.
• Assist and support manufacturing unit team and plant needs and goals.
• Communicate daily with prior and post shift Quality Control Representatives.
• Support internal and external audits.
• Able to work accurately with limited supervision.
• Report out of control conditions and assist in analysis of those for operations.
• Assist in training manufacturing personnel relative to inspection techniques and documentation of inspection results.
• Conduct routine flash audits as directed to ensure compliance to the quality system.
• Review inspection techniques and documentation of results performed by manufacturing personnel.
• Other duties as required to support the needs of the business

Skills

Attention to detail

Problem solving

Communication skills

Time management

Teamwork

Minimal supervision

Education

HSD/GED

Associates Degree – Quality Assurance/related field

Tools

SAP

Trackwise

Prolink

Job description

BD is seeking a Quality Assurance professional at its Columbus, NE Molding Center to generate quality notifications, perform risk assessments, and drive CAPA activities. The role requires inspecting processes, applying sampling plans, and collaborating with manufacturing staff to sustain cGMP compliance.

The candidate should have 3–5 years of manufacturing QA experience or an Associate’s in QA, with proficiency in SAP, Trackwise, and data analysis tools like Excel/Minitab.