Quality Engineer

Scanlan Int'l • St. Paul, MN

17d • Onsite

About The Position

Scanlan International, Inc., a family-owned medical device company specializing in surgical instruments, is seeking a Quality Engineer to support product quality, supplier quality, and continuous improvement across manufacturing and supply chain operations. The role works with Engineering, Instrumentation, Purchasing, Regulatory, external artisans, and suppliers to ensure materials, processes, and finished products meet company requirements, customer expectations, and applicable quality system standards. It leads customer complaint investigations, supplier qualification and monitoring, nonconformance investigations, corrective and preventive actions, process improvement, and quality planning. The position is based at the company headquarters south of downtown St. Paul and works onsite Monday through Friday. It reports to the Quality Manager.

The work is allocated approximately 35% to quality engineering support, 35% to supplier quality support, 20% to quality control support, and 10% to quality management system support. The Quality Engineer supports investigations and corrective actions, evaluates and develops suppliers, supports audits and incoming inspection improvements, chairs material review board meetings, analyzes quality data, maintains quality documentation, and promotes compliance with quality system, customer, regulatory, and internal requirements.

Requirements

• Bachelor’s degree in Engineering, Quality, Manufacturing, Industrial Technology, Life Sciences, or a related technical discipline; equivalent experience may be considered.
• Three or more years of experience in quality engineering, supplier quality, or a related technical quality role.
• Working knowledge of quality system requirements and regulated manufacturing practices, such as ISO 9001, ISO 13485, FDA Quality Management System Regulation (QMSR), or other applicable standards.
• Experience with nonconformance management, complaint handling, root cause analysis, corrective action, preventive action, and verification of effectiveness.
• Ability to read and interpret engineering drawings, specifications, inspection requirements, and technical documentation.
• Familiarity with measurement systems, inspection methods, sampling plans, process capability, and basic statistical analysis.
• Strong written and verbal communication skills, including the ability to work effectively with suppliers and cross-functional teams.
• Ability to manage multiple priorities, document decisions clearly, and follow issues through closure.
• Authorization to work in the United States; the company will not offer or assume employment visa sponsorship.

Nice To Haves

• ASQ certification such as Certified Quality Engineer, Certified Quality Auditor, or Six Sigma Green Belt.
• Experience as a Quality Engineer or Supplier Quality Engineer in medical devices, precision manufacturing, contract manufacturing, machining, assembly, or another highly regulated manufacturing environment.
• Supplier audit experience or formal auditor training or certification.
• Experience with process validation, test method validation, PPAP, FMEA, control plans, GR&R, SPC, or risk management tools.
• Experience using ERP, QMS, document control, supplier management, or statistical analysis software.
• Knowledge of GD&T and practical application of dimensional inspection techniques.

Responsibilities

• Support and maintain quality engineering activities for assigned products, processes, suppliers, and purchased components.
• Lead investigations into nonconforming material, production quality issues, supplier quality concerns, and customer-related quality events.
• Initiate, review, approve, and verify the effectiveness of supplier corrective action requests and assigned internal CAPA activities.
• Drive root cause analysis and corrective and preventive action using structured methods such as 5 Why, fishbone analysis, or 8D.
• Evaluate supplier performance using scorecards, trend analysis, quality metrics, response timeliness, audit results, and defect performance.
• Participate in supplier selection, qualification, approval, development, monitoring, and periodic re-evaluation.
• Plan, conduct, or support supplier audits and follow up on findings through closure.
• Review supplier manufacturing processes, inspection methods, control plans, process capability, and change notifications for quality impact.
• Support continuous improvement of incoming inspection requirements, sampling plans, inspection criteria, and measurement methods.
• Chair material review board (MRB) meetings to determine disposition of nonconforming materials.
• Collaborate with Engineering and Instrumentation on design and process changes, validation activities, risk assessments, and transfer-to-production work.
• Analyze quality data to identify trends, recurring issues, supplier risks, and improvement opportunities.
• Support development and maintenance of quality documentation, procedures, work instructions, specifications, forms, and records.
• Promote compliance with applicable quality system requirements, customer requirements, regulatory expectations, and internal procedures.
• Communicate quality expectations to internal and external stakeholders and escalate significant risks or performance issues in a timely manner.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Group life insurance
• Short-term disability insurance
• Long-term disability insurance
• 401(k) plan with company match
• Workers' compensation
• Employee Assistance Program (EAP)
• Training and Development Program
• Tuition Assistance Program
• Paid time off, including holidays, floating holidays, vacation, and earned sick and safe time (ESST)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level