Quality Systems & Manufacturing Engineer

Description

About the Role

Global Surgical Corporation is seeking a hands-on Quality Systems & Manufacturing Engineer to lead our Quality Management System (QMS), support regulatory compliance activities, and drive quality improvements within manufacturing operations.

This role combines quality systems leadership, manufacturing quality engineering, and routine regulatory compliance responsibilities. The successful candidate will work closely with Engineering, Manufacturing, Quality, Technical Service, suppliers, and executive leadership to ensure products and processes consistently meet customer, company, and regulatory requirements.

This is an ideal opportunity for an individual who enjoys improving systems, solving manufacturing problems, leading investigations, and building practical processes within a regulated manufacturing environment.

Essential Responsibilities

Quality Management Systems

• Serve as the primary operational owner of the company Quality Management System.
• Maintain and improve QMS processes including: 
  • Document Control
  • Training
  • Change Control
  • CAPA
  • Complaint Handling
  • Internal Audits
  • Supplier Qualification
  • Management Review
  • Risk Management
  • Process Validation
• Revise and simplify procedures, work instructions, forms, and workflows to improve effectiveness while maintaining compliance.
• Coordinate employee training on new and revised quality processes.
• Monitor quality metrics and report trends, risks, and improvement opportunities to management.
• Support audit readiness and continuous improvement initiatives.

Complaint Handling & CAPA

• Administer complaint handling and investigation processes.
• Review complaints, determine investigation requirements, and coordinate cross-functional investigations.
• Lead corrective and preventive action activities.
• Analyze complaint, service, warranty, and quality records for recurring trends.
• Manage nonconforming product and corrective action activities.
• Ensure quality records are complete, accurate, and inspection ready.

Manufacturing Quality Engineering

• Provide hands-on support to manufacturing operations.
• Lead root cause investigations for quality and production issues.
• Improve manufacturing processes, inspection methods, and quality controls.
• Analyze quality data to identify opportunities for scrap reduction, improved yield, and process improvements.
• Support process validation activities and manufacturing change implementation.
• Assist in developing work instructions, inspection procedures, and quality plans.
• Partner with manufacturing teams to improve product quality and operational efficiency.

Supplier Quality

• Support supplier qualification and monitoring activities.
• Investigate supplier-related quality issues.
• Lead supplier corrective action requests when necessary.
• Establish and maintain supplier quality requirements and performance metrics.
• Participate in supplier audits and supplier improvement initiatives.

Change Control & Product Support

• Review engineering and manufacturing changes for quality and regulatory impact.
• Support Engineering Change Order (ECO) implementation.
• Ensure documentation, training, validation, and approvals are completed prior to implementation.
• Support product releases and manufacturing transfers.
• Participate in risk assessments and product improvement activities.

Regulatory Compliance

• Maintain regulatory records, registrations, and UDI/GUDID information.
• Support FDA, Canada, EU, UK, and other applicable regulatory requirements.
• Assist with distributor requests, product registrations, declarations, and compliance documentation.
• Evaluate routine regulatory impact of product, supplier, process, and labeling changes.
• Support complaint evaluations for potential regulatory reporting requirements.
• Coordinate activities with external testing laboratories, certification bodies, and regulatory consultants as needed.

Requirements

Qualifications

Required

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related technical field, or equivalent experience.
• 5+ years of experience in Quality Engineering, Quality Systems, Manufacturing Engineering, or a related role within a regulated manufacturing environment.
• Experience with: 
  • CAPA
  • Complaint Handling
  • Change Control
  • Internal Audits
  • Supplier Quality
  • Nonconforming Product
  • Document Control
  • Quality System Administration
• Experience conducting root cause investigations and implementing corrective actions.
• Ability to read and interpret technical drawings, specifications, and manufacturing documentation.
• Strong communication, organizational, and project-management skills.
• Ability to work independently and manage multiple priorities.

Preferred

• Medical device manufacturing experience.
• Knowledge of FDA Quality Management System Regulation (QMSR) and ISO 13485.
• Experience with UDI/GUDID and international product registrations.
• Familiarity with ISO 14971 risk management principles.
• Experience with process validation and FMEA activities.
• Supplier audit experience.
• ASQ CQE, CQA, Six Sigma, or related certifications.
• Experience with ERP, eQMS, CAPA, or document-control systems.

Authority & Decision Making

This position is authorized to:

• Place nonconforming material on hold.
• Require investigations and corrective actions.
• Initiate CAPAs.
• Reject incomplete change requests.
• Escalate quality, compliance, or product-safety concerns.
• Approve assigned quality-system documents and records.
• Recommend product release holds when requirements are not met.

What Success Looks Like

Successful performance in this role includes:

• Timely closure of complaints, CAPAs, and nonconformance investigations.
• Improved QMS effectiveness and employee adoption of procedures.
• Reduced manufacturing defects, scrap, rework, and recurring quality issues.
• On-time completion of regulatory and compliance activities.
• Improved supplier performance and quality metrics.
• Effective support of manufacturing operations while maintaining regulatory compliance.
• Clear, practical processes that are understood and followed throughout the organization.

Why Join Global Surgical?

• Direct impact on product quality, compliance, and patient care.
• High visibility role with direct interaction with company leadership.
• Opportunity to shape and improve the Quality Management System.
• Broad exposure across manufacturing, engineering, quality, regulatory, and operations.
• Collaborative environment where individual contributions make a meaningful difference