Quality Systems & Manufacturing Engineer

Description

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

• 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…