Elos Medtech · 8 hours ago
Quality Inspector – 2nd Shift
Memphis, TN
Full-time
Onsite
Entry, Mid Level
2+ years expElos Medtech is a leading development and production partner for medical technology companies worldwide. They are seeking a full-time 2nd shift Quality Inspector to ensure the highest standards of quality and compliance in medical device production, critical for maintaining product integrity, patient safety, and regulatory compliance.
Health CareLocal BusinessManufacturingPersonal Health
Responsibilities
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 craftsmanship and precision when inspecting components and assemblies
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 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
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
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
Qualification
Required
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 craftsmanship and precision when inspecting components and assemblies
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 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
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
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
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
Minimum 2 years of experience in quality inspection, preferably in the medical device or regulated manufacturing industry
Education: High school diploma or equivalent
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
Preferred
Background working in cleanroom, GMP, or ISO-certified environments desirable
Familiarity with CAPA processes, audits, and regulatory inspections
Company
Elos Medtech
Elos Medtech employs 1,500 people in four business units – Dental, Orthopedics, Advanced Surgical and Precision - and the divisions Medical Polymer Solutions, Sterile Packaging Solutions and Medical Value Solutions.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-07-27Acquired
Leadership Team
Ewa Linsäter
Chief Accounting, Compliance and M&A Officer
Recent News
globallegalchronicle.com
2023-12-30
Squire Patton Boggs
2023-12-25
2023-11-22
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