Quality Inspector

About the role

The Quality Inspector plays a crucial role in ensuring the highest standards of quality and compliance in Elos Medtech's medical device production. This position is essential for maintaining product integrity, patient safety, and regulatory compliance.

Responsibilities

• PASSION: Demonstrate commitment to patient safety by ensuring every device meets the highest quality standards
• STAY CURRENT: Stay current with industry regulations (e.g., FDA, ISO 13485) and continuously seek ways to improve inspection processes
• TAKE PRIDE: Take pride in craftsmanship and precision when inspecting components and assemblies
• PERFORM THROUGH: Perform thorough in-process and final inspections of medical devices, ensuring compliance with specifications, drawings, and regulatory standards
• Maintain accurate and transparent quality control records
• ENSURE COMPLIANCE: Ensure compliance with regulatory requirements and internal procedures
• IDENTIFY AND REPORT: Identify and report defects or non-conformances with integrity and objectivity
• SUPPORT AUDITS: Support audits by providing reliable documentation and insights
• DRIVE RESULTS: Perform thorough inspections using precision tools to verify product specifications
• SUPPORT CAPA: Support CAPA initiatives to resolve quality issues and prevent recurrence
• MANTAIN AND CALIBRATE: Maintain and calibrate inspection equipment to ensure consistent performance
• MEET DEADLINES: Meet deadlines and production goals without compromising quality
• COLLABORATE: Work closely with production and engineering teams to resolve quality concerns
• TRAIN STAFF: Train staff on quality standards and inspection techniques
• IMPROVE PROCESSES: Participate in cross-functional meetings to improve processes and share best practices
• COMMUNICATE CLEARLY: Communicate clearly and constructively with team members, production staff, and leadership

Qualifications

• ABILITY TO USE TOOLS: Ability to use calipers, micrometers, CMMs, optical comparators, and other precision tools
• FAMILIARITY WITH STANDARDS: Familiarity with ISO 13485, FDA, and GMP standards
• ACCURATE RECORDKEEPING: Accurate recordkeeping, non-conformance reporting, and audit support
• BASIC OFFICE SKILLS: Basic Microsoft Office skills and ERP systems
• ABILITY TO TRAIN: Ability to train others in inspection procedures and quality standards
• EFFECTIVE COMMUNICATION: Effective communication skills to interact with team members, production staff, and leadership
• INDEPENDENCE: Ability to work independently or collaboratively in a fast-paced manufacturing environment
• FLEXIBILITY: Flexibility to adapt to changing priorities

Skills

• ABILITY TO USE TOOLS: Ability to use calipers, micrometers, CMMs, optical comparators, and other precision tools
• FAMILIARITY WITH STANDARDS: Familiarity with ISO 13485, FDA, and GMP standards
• ACCURATE RECORDKEEPING: Accurate recordkeeping, non-conformance reporting, and audit support
• BASIC OFFICE SKILLS: Basic Microsoft Office skills and ERP systems
• ABILITY TO TRAIN: Ability to train others in inspection procedures and quality standards
• EFFECTIVE COMMUNICATION: Effective communication skills to interact with team members, production staff, and leadership
• INDEPENDENCE: Ability to work independently or collaboratively in a fast-paced manufacturing environment
• FLEXIBILITY: Flexibility to adapt to changing priorities

Experience

• MINIMUM EXPERIENCE: Minimum 2 years of experience in quality inspection, preferably in the medical device or regulated manufacturing industry
• BACKGROUND WORKING: Background working in cleanroom, GMP, or ISO-certified environments desirable
• FAMILIARITY WITH CAPA: Familiarity with CAPA processes, audits, and regulatory inspections

Education

• EDUCATION: High school diploma or equivalent

Physical Demands

• ABILITY TO STAND OR SIT: Ability to stand or sit for extended periods while performing inspections
• FREQUENT REPEATED MOVEMENTS: Frequent repetitive hand and arm movements when using precision tools and equipment
• ABILITY TO LIFT: Ability to lift, carry, push, and/or pull up to 20 lbs. independently; occasional lifting of heavier objects may be required with mechanical assistance or team lift
• PERSONAL PROTECTIVE EQUIPMENT: Must be able to wear appropriate Personal Protective Equipment (PPE), including but not limited to safety glasses, gloves, protective clothing, and hearing protection as dictated by task and environment
• VISUAL ACUITY: Visual acuity sufficient to conduct detailed inspections of equipment and parts, read technical documentation, and view computer screens
• HARING ABILITY: Hearing ability sufficient to perceive alarms, equipment signals, and verbal instructions in a manufacturing environment
• ABILITY TO BEND, STOOP, REACH: Must be able to bend, stoop, reach, and work in confined or awkward positions as necessary to access equipment and perform maintenance tasks

Working Conditions

• MANUFACTURING AND CLEANROOM ENVIRONMENTS
• STANDARD SCHEDULE: Monday-Friday on first shift, weekend work as needed

Reporting Structure

This position reports to the Value Stream Supervisor