Quality Systems Specialist II - 1st Shift

Quality Systems Specialist II – 1st Shift (Columbus, NE)

Quality Systems Specialist II – 1st Shift at BD is responsible for maintaining site‑wide compliance with Quality Systems, conducting audits, managing corrective and preventative actions (CAPA), training personnel, and leading root cause investigations.

• Provide assistance with hosting customer audits, maintain minutes, generate reports, and track completion of audit actions.
• Represent BD in customer‑facing roles during audits and conduct internal audits as lead auditor.
• Maintain quality metrics, review data, and initiate CAPA when necessary.
• Perform root‑cause investigations for customer complaints, generate reports, and follow up on corrective actions.
• Support site and worldwide quality boards, management reviews, and data capture and reporting.
• Coordinate and follow up on actions to meet due dates.
• Act as liaison with BDM, PS sites (Franklin Lakes, Pont de Claix, Cuautitlán), and the BD Corporate Document group on document control matters.
• Ensuring compliance with BD quality systems, policies, procedures, ISO, cGMP, BDM, PS, and BDX requirements.

• Review and approve documentation packages; reject packages that do not comply with process or system requirements.
• Ensure compliance with BDM, PS, and BDX requirements for document types and formats.
• Develop and deliver training on the documentation system and the Engineering Change Order process.
• Maintain the site Electronic Document System (eDoc), including security, menus, placement of documents, and printing restrictions.
• Provide Help Desk support and coordinate incident tickets with the system administrator.
• Approve all site document revisions/creations and associated Engineering Change Orders.
• Assist change originators in coordinating document releases.
• Coordinate the site 3‑year review program and report compliance to plant leadership.
• Maintain document templates, user accounts, procedures, and legacy systems.
• Lead conversions and upgrades to documentation systems and implement efficiency improvements.

BA/BS degree in Science, Business, Quality, or Manufacturing‑related field.

• 2‑3 years of experience with BDM, PS product and production methods, including Quality System standards (QSR, GMP, ISO).
• Prior experience applying the plant Quality System and SAP preferred.

• Attention to detail
• Understanding of manufacturing processes and documentation systems
• Computer skills:
  Windows, Word, Excel, Documentum, SAP, and database programs
• Complete understanding of CD/ECM change‑management procedures
• Communication, analytical, problem‑solving, organizational, interpersonal, self‑motivated, change management, and leadership skills

• Competitive pay with Daily Pay option
• Healthcare coverage with no paycheck contributions for eligible associates under a qualification threshold
• Dental and vision insurance at group rates
• Paid parental leave up to 6 weeks
• 401(k) plan with up to 6 % match
• Company‑paid basic life and AD&D insurance
• Tuition reimbursement and adoption assistance
• Paid holidays and vacation (prorated for the first year)

BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, citizenship status, marital or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military, veteran status, or other legally protected characteristics.

BD supports a collaborative culture that encourages growth, innovation, and accountability. It offers learning opportunities, flexible work arrangements, and a supportive environment for all employees.