Quality Engineer

Scanlan International, Inc.; Minnesota; On-site; USD 87,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

Group Life Insurance

Short-Term Disability Insurance

Long-Term Disability Insurance

401(k) Plan with Company Match

Paid Time Off and Holidays

Job summary

Scanlan International, Inc. is a medical device company seeking a Quality Engineer to support product quality, supplier quality, and continuous improvement across manufacturing and supply chain. You will partner with Engineering, Regulatory, and suppliers to ensure materials, processes, and finished products meet requirements and quality system standards.

This on-site role at our St. Paul HQ reports to the Quality Manager.

Qualifications

• Bachelor’s degree or equivalent experience in a technical discipline.
• 3+ years in quality engineering, supplier quality, or related role.
• Experience with quality system requirements and regulated manufacturing practices.

Responsibilities

• Lead quality engineering support for products, processes, suppliers, and components.
• Manage investigations for nonconforming material and production quality issues; drive CAPA activities.
• Evaluate supplier performance and participate in supplier audits and development.
• Support quality documentation, procedures, work instructions, and records; promote compliance with standards.

Skills

Quality system compliance

Root cause analysis

Statistics & data analysis

Documentation & recordkeeping

Supplier communication

Reading engineering drawings

Education

Bachelor’s degree in Engineering, Quality, Manufacturing, Industrial Technology, Life Sciences, or related field

Tools

ERP systems

QMS software

Job description

Scanlan International, Inc., is a medical device company specializing in the highest-quality surgical instruments. Now in our fourth generation, the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world. We are seeking a Quality Engineer to join our organization and continue this commitment.

The Quality Engineer is responsible for supporting product quality, supplier quality, and continuous improvement activities across manufacturing and supply chain operations. This role partners 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. The position will lead customer complaint investigations, supplier qualification and monitoring, nonconformance investigations, corrective and preventive actions, process improvement, and quality planning activities. The ideal candidate combines strong technical judgment, data-driven decision making, supplier-facing communication skills, and hands-on experience in a regulated manufacturing environment.

This position is located at our headquarters office, south of downtown St. Paul. We welcome an on-site work environment from Monday to Friday. This position reports to the Quality Manager

What You’ll Do As a Quality Engineer:

35% -- Quality Engineering support:

• Support and maintain quality engineering activities for assigned products, processes, suppliers, and purchased components.
• Lead investigations for 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 internal CAPA activities as assigned.
• Drive root cause analysis and corrective/preventive action using structured problem-solving methods such as 5 Why, fishbone analysis, 8D, or similar tools.

35% -- Supplier Quality support:

• Evaluate supplier performance through scorecards, trend analysis, quality metrics, on-time response, audit results, and defect performance.
• Participate in supplier selection, qualification, approval, development, monitoring, and periodic re-evaluation activities.
• Plan, conduct, or support supplier audits and follow up on audit findings through closure.
• Review supplier manufacturing processes, inspection methods, control plans, process capability, and change notifications for quality impact.

20% -- Quality Control support:

• Support the continuous improvement of incoming inspection requirements, sampling plans, inspection criteria, and measurement methods.
• Chair MRB meetings to determine disposition of nonconforming materials.

10% -- Quality Management System support:

• Collaborate with Engineering and Instrumentation on design changes, process changes, validation activities, risk assessments, and transfer-to-production work.
• Analyze quality data to identify trends, recurring issues, supplier risks, and opportunities for improvement.
• 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 clearly to internal and external stakeholders, including timely escalation of significant risks or performance issues.

Required Qualifications:

Education:

• Bachelor’s degree in Engineering, Quality, Manufacturing, Industrial Technology, Life Sciences, or a related technical discipline; equivalent experience may be considered.

Experience:

• Three or more years of experience in quality engineering, supplier quality, or a related technical quality role.

Skills

• 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.
• Demonstrated ability to manage multiple priorities, document decisions clearly, and follow issues through closure.

Preferred Qualifications:

Education:

• ASQ certification such as Certified Quality Engineer, Certified Quality Auditor, or Six Sigma Green Belt.

Experience:

• Experience as a Quality Engineer or Supplier Quality Engineer in medical devices, precision manufacturing, contract manufacturing, machining, assembly, or other highly regulated manufacturing environments.
• Supplier audit experience or formal auditor training/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.

Skills:

• Knowledge of GD&T and practical application of dimensional inspection techniques.

U.S. Work Authorization & Sponsorship

Scanlan International will not offer or assume sponsorship of an employment visa for this position.

Compensation

We are committed to equitable and transparent pay practices. The salary range for this position is $87,200 – 139,500, representing the minimum and maximum of our compensation structure. Starting pay will typically fall between these values and is determined based on factors such as relevant experience, skills, and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications.

• - Medical, Dental, and 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)

Scanlan International is an EEO employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as protected veteran.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please click the following link to view Federal and E-Verify posters: https://www.e-verify.gov/employees