Senior Quality Engineer: Lead CAPA & QMS Initiatives

Actalent; Saint Paul (MN); On-site; USD 92,000 - 98,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

401(k) Match

Paid Holidays

Vacation Time

Sick Time

Disability Insurance

Tuition Reimbursement

Life Insurance

Job summary

Actalent is seeking an experienced Quality Engineer to lead advanced quality initiatives across manufacturing processes and drive continuous improvement. The role requires strong CAPA, root cause analysis, and cross-functional collaboration to uphold ISO 9001 standards.

Responsibilities include managing complex quality projects, applying FMEA/8D methods, and mentoring junior engineers while maintaining robust QMS practices on the production floor and in office environments.

Qualifications

• Bachelor's degree in engineering is required.
• 5+ years in quality engineering or related field.
• Experience in metalworking environments.
• Strong knowledge of QMS and ISO 9001.
• Proficient in CAPA, root cause analysis and corrective actions.

Responsibilities

• Lead quality initiatives across manufacturing processes.
• Manage complex quality projects from concept to completion.
• Perform root cause analysis and develop CAPA plans.
• Collaborate with cross-functional teams to address quality issues.
• Develop and maintain quality inspection plans across stages.
• Apply FMEA and 8D methods to identify risks.
• Lead lean/Six Sigma improvement projects.
• Support quality audits and ensure regulatory compliance.
• Analyze quality data to drive data-based decisions.
• Maintain adherence to QMS and ISO 9001 standards.
• Mentor junior engineers and nurture a quality culture.
• Coordinate multiple projects to meet deadlines.
• Prepare documentation and presentations for stakeholders.
• Engage with internal teams and customers on CAPAs.

Skills

Quality engineering

Root cause analysis

CAPA processes

FMEA

8D problem solving

Lean Six Sigma

Data analysis

Auditing

Cross-functional

ISO 9001

Mentoring

Education

Bachelor's degree in Engineering

Tools

QMS software

Statistical tools

Job description

Actalent is seeking an experienced Quality Engineer to lead advanced quality initiatives across manufacturing processes and drive continuous improvement. The role requires strong CAPA, root cause analysis, and cross-functional collaboration to uphold ISO 9001 standards.

Responsibilities include managing complex quality projects, applying FMEA/8D methods, and mentoring junior engineers while maintaining robust QMS practices on the production floor and in office environments.