Senior Quality Engineer

Real Staffing; Saint Paul (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Real Staffing is seeking a Senior Quality Engineer to drive CAPA and QMS improvements in a regulated environment. The role emphasizes hands-on leadership ensuring timely CAPA closure, NCR oversight, and robust root cause analysis across cross-functional teams.

The successful candidate will maintain and improve QMS procedures, support internal and external audits, and apply data-driven approaches to enhance product quality and compliance within a fast-paced setting.

Qualifications

• Bachelor's degree in Engineering, Quality, or related field.
• 5–8+ years of quality engineering experience in regulated environments.
• Deep CAPA and NCR systems experience.
• Strong root cause analysis and data-driven problem solving.
• Hands-on QMS maintenance and regulatory knowledge.

Responsibilities

• Lead end-to-end CAPA processes including initiation, investigation, implementation, and effectiveness verification.
• Review, disposition, and manage Nonconformance Reports (NCRs) with cross-functional collaboration.
• Conduct structured root cause investigations to drive corrective actions.
• Support development and maintenance of the Quality Management System (QMS) and regulatory audits.
• Drive continuous improvement initiatives using data analysis and quality tools.

Skills

CAPA management

NCR handling

Root cause analysis

QMS maintenance

Regulatory knowledge

Data analysis

Education

Bachelor's degree in Engineering/Quality

Tools

eQMS software

Job description

Senior Quality Engineer (CAPA / QMS Focus)

Location: Twin Cities, MN

Full-time | Onsite

Position Summary

We are seeking an experienced and detail-oriented Senior Quality Engineer to drive continuous improvement across our Quality Management System (QMS). This role will lead and manage Corrective and Preventive Actions (CAPAs), oversee Nonconformance Reports (NCRs), conduct in-depth root cause analyses, and ensure ongoing compliance with regulatory and internal quality standards.

This role requires a highly hands‑on, self‑directed engineer comfortable managing multiple CAPAs simultaneously in a small‑team environment, with experience in complaint investigations, NCMR processes, and supporting quality activities for clinical‑stage or Class II/III medical devices (PMA experience a plus).

Key Responsibilities

CAPA Management

• Lead end‑to‑end CAPA processes, including initiation, investigation, implementation, and effectiveness verification
• Ensure timely closure of CAPAs in compliance with internal procedures and regulatory requirements
• Identify systemic issues and recommend preventative actions across the organization
• Track and trend CAPA data to drive continuous improvement initiatives

Nonconformance (NCR) Oversight

• Review, disposition, and manage Nonconformance Reports (NCRs)
• Collaborate cross‑functionally to assess impact and determine appropriate actions
• Ensure accurate documentation and traceability of nonconformance handling
• Analyze NCR trends to identify recurring issues and improvement opportunities

Root Cause Analysis

• Conduct and facilitate structured root cause investigations (e.g., 5 Whys, Fishbone, Fault Tree Analysis)
• Drive cross‑functional problem‑solving efforts for complex quality issues
• Ensure root cause identification is data‑driven, thorough, and sustainable
• Coach teams on effective problem‑solving methodologies

Quality Management System (QMS) Maintenance

• Support the development, implementation, and continuous improvement of the QMS
• Ensure compliance with applicable standards (e.g., ISO 9001, ISO 13485, AS9100, or industry‑specific regulations)
• Lead internal audits and support external regulatory audits and inspections
• Maintain and improve quality procedures, work instructions, and documentation
• Monitor key quality metrics and report on system effectiveness

Continuous Improvement

• Drive initiatives that improve product quality, reduce defects, and enhance process efficiency
• Utilize data analysis and quality tools (e.g., SPC, Pareto analysis) to identify improvement areas
• Partner with engineering, manufacturing, and operations teams to implement solutions

Qualifications

Required

• Bachelor's degree in Engineering, Quality, or related technical field
• 5-8+ years of Quality Engineering experience in a regulated industry (e.g., medical device, aerospace, manufacturing)
• Deep experience with CAPA and NCR systems
• Strong expertise in root cause analysis methodologies
• Hands‑on experience maintaining and improving a Quality Management System (QMS)
• Working knowledge of relevant industry standards (ISO, FDA, or equivalent)
• Excellent problem‑solving, analytical, and organizational skills

Preferred

• ASQ certifications (e.g., CQE, CQA)
• Experience with electronic QMS (eQMS) platforms
• Lean Six Sigma (Green Belt or Black Belt)
• Experience supporting audits and regulatory inspections

Key Competencies

• Structured problem‑solving and investigative mindset
• Strong attention to detail and documentation discipline
• Ability to influence cross‑functional teams
• Data‑driven decision‑making
• Continuous improvement orientation

Why Join Us

• Opportunity to shape and strengthen quality systems at a strategic level
• High visibility role with cross‑functional collaboration
• Dynamic environment focused on innovation and excellence

EOE Statement

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct‑hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.