Quality Inspector

Elos Medtech AB; Memphis (TN); On-site; USD 42,000 - 62,000; Full time

Job summary

Elos Medtech AB in Memphis, TN is seeking a full-time Quality Inspector to ensure the highest standards of quality and regulatory compliance in medical device production.

Responsibilities include performing in-process and final inspections with calipers, micrometers, CMMs and optical comparators, maintaining accurate records, supporting CAPA and audits, and collaborating with production and engineering to resolve quality concerns and protect patient safety.

Qualifications

• High school diploma or equivalent is required.
• Minimum 2 years of quality inspection experience, preferably in medical devices or regulated manufacturing.
• Experience in cleanrooms, GMP or ISO-certified environments is desirable.

Responsibilities

• Perform in-process and final inspections of medical devices to ensure specifications, drawings, and regulatory standards are met.
• Maintain accurate quality control records and support audits and CAPA initiatives.
• Calibrate and maintain inspection equipment to ensure consistent performance.
• Collaborate with production and engineering teams to resolve quality concerns and train staff on inspection procedures.
• Communicate findings clearly to leadership and participate in cross-functional process improvements.

Skills

Precision tools

Quality systems knowledge

Recordkeeping

Training others

Communication

Independent/Team work

Education

High school diploma or equivalent

Tools

Calipers

Micrometers

CMMs

Optical comparators

ERP systems

Job description

Elos Medtech, a leading development and production partner for medical technology companies worldwide. At our locations in Sweden, Denmark, Switzerland, Germany, China, and the USA, Elos runs operations in four business areas - Dental, Orthopedics, Advanced Surgical and Precision. Elos Medtech has extensive expertise and specializes in development and design, along with contract manufacturing of medical devices, such as implants and instruments. We are always aware of the millions of patients we can help worldwide and are committed to meeting and exceeding our customers' high expectations. The company, headquartered in Gothenburg, Sweden, employs more than 1,500 people worldwide. In a globally growing healthcare market, we are looking for a full-time Quality Inspector to strengthen our team in Memphis, TN.

The Quality Inspector ensures that the highest standards of quality and compliance in our medical device production are met. This role is critical to maintaining product integrity, patient safety, and regulatory compliance.

Essential Job Functions

• PASSION
  • Demonstrate commitment to patient safety by ensuring every device meets the highest quality standards
  • Stay current with industry regulations (e.g., FDA, ISO 13485) and continuously seek ways to improve inspection processes
  • Take pride in craftmanship and precision when inspecting components and assemblies
  • Perform through in-process and final inspections of medical devices, ensuring compliance with specifications, drawings, and regulatory standards.
• TRUSTWORTHINESS
  • Maintain accurate and transparent quality control records
  • Ensure compliance with regulatory requirements and internal procedures
  • Identify and report defects or non-conformances with integrity and objectivity
  • Support audits by providing reliable documentation and insights
• DRIVE RESULTS
  • Perform thorough inspections using precision tools to verify product specifications
  • Support CAPA initiatives to resolve quality issues and prevent recurrence
  • Maintain and calibrate inspection equipment to ensure consistent performance
  • Meet deadlines and production goals without compromising quality
• COLLABORATION
  • Work closely with production and engineering teams to resolve quality concerns
  • Train staff on quality standards and inspection techniques
  • Participate in cross functional meetings to improve processes and share best practices
  • Communicate clearly and constructively with team members and leadership
• Other duties as assigned

Skills

• Ability to use calipers, micrometers, CMMs, optical comparators, and other precision tools
• Familiarity with ISO 13485, FDA, and GMP standards
• Accurate recordkeeping, non-conformance reporting and audit support
• Basic Microsoft Office skills and ERP systems
• Ability to train others in inspection procedures and quality standards
• Effective communication skills to interact with team members, production staff, and leadership.
• Ability to work independently or collaboratively in a fast-paced manufacturing environment.
• Flexibility to adapt to changing priorities.

Experience

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

Education

• High school diploma or equivalent

Physical Demands

• Ability to stand or sit for extended periods while performing inspections
• Frequent repetitive hand and arm movements when using precision tools and equipment
• Must be able 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.
• Required 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 sufficient to conduct detailed inspections of equipment and parts, read technical documentation, and view computer screens.
• Hearing ability sufficient to perceive alarms, equipment signals, and verbal instructions in a manufacturing environment.
• 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 is Monday-Friday on first shift, weekend work as needed

REPORTING STRUCTURE

• This position reports to the Value Stream Supervisor