Regulatory Quality Engineer

ARCH Medical Solutions – MedTorque is seeking an experienced Regulatory Quality Engineer. This position may be based at either our Elmhurst, Illinois or Kenosha, Wisconsin facility and is responsible for supporting quality system and regulatory compliance activities across both medical device manufacturing locations.

The Regulatory Quality Engineer serves as the Quality System Management Representative and plays a key role in ensuring compliance with FDA regulations, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements. This position is responsible for maintaining and enhancing the effectiveness of the Quality Management System (QMS), leading quality system initiatives, supporting audits and inspections, and driving continuous improvement efforts. Working closely with cross-functional teams, the Regulatory Quality Engineer helps ensure product quality, regulatory compliance, and operational excellence throughout the organization.

Key Responsibilities

• Serve as the Quality System Management Representative for both manufacturing facilities.
• Establish, implement, maintain, and continuously improve Quality Management System (QMS) processes and procedures.
• Promote awareness of regulatory and quality system requirements and provide training to employees.
• Maintain FDA Establishment Registrations and Device Listings and serve as a direct liaison with the FDA.
• Support and lead activities related to: Engineering Change Orders (ECOs), Corrective and Preventive Actions (CAPAs), Material Review Board (MRB) processes, Risk Management, Nonconformance investigations, Corrective action effectiveness verification
• Plan, conduct, and manage supplier, internal, customer, regulatory, and process audits, including documentation and follow-up activities.
• Establish and maintain validation programs, including coordination of manufacturing process validations.
• Develop and monitor quality metrics and key performance indicators.
• Collaborate with suppliers, customers, and cross-functional teams to resolve quality and compliance issues.
• Support regulatory inspections and customer audits.
• Drive continuous improvement initiatives to enhance product quality, compliance, and operational effectiveness.

Qualifications Required

• Bachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering is strongly preferred or equivalent,
• or five to ten years of experience in medical device manufacturing industry and in the quality engineering role, and/or training,
• or equivalent combination of education and experience.
• Knowledge of the medical device manufacturing industry.
• Strong regulatory background in medical device manufacturing.
• Strong knowledge of EU MDR and MDSAP requirements.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485 Quality Management System requirements.
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5.
• Familiarity with test methods and standards used for medical device design verification and validation.
• U.S. citizenship required.

Pay: $90,310.67 - $93,110.79 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Tuition reimbursement
• Vision insurance

Application Question(s):

• Have you ever been a primary contact during an FDA inspection or regulatory audit?

• Do you have experience with FDA 21 CFR Part 820 and ISO 13485?

Experience:

• quality and regulatory compliance: 5 years (Required)

Work Location: In person

Benefits:

Salary : $90,311 - $93,111