Quality Control Specialist

Route 92 Medical; West Jordan (UT); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Comprehensive healthcare benefits

Competitive base pay

Generous paid time off

12 weeks of paid parental leave

Monthly cell phone stipend

Job summary

A medical device company located in West Jordan, UT, is hiring for a quality assurance position to ensure compliance with regulatory requirements, including FDA QSR and ISO standards. This role involves receiving and inspecting components, performing equipment maintenance, and supporting other quality assurance functions. Ideal candidates should have at least 3 years of experience in the medical device industry, be adaptable, and have excellent attention to detail. Comprehensive healthcare benefits and competitive pay are offered.

Qualifications

• Minimum of 3 years of work experience in the medical device industry.
• Experience with inspection tools such as calipers and gauges.
• Working knowledge of 1385:2016 preferred.

Responsibilities

• Receiving and inspecting components and supplies.
• Scheduling and performing equipment calibration and preventive maintenance.
• Processing nonconforming materials and product returns.
• Processing of nonconforming materials / products
• Processing of device returns
• Transferring to and from inventory locations
• General support for other QA functions as needed

Skills

Adaptable to a fast-paced environment

Attention to detail

Education

High School Graduate or equivalent

Associate’s degree in a technical field

Tools

Inspection tools (calipers, gauges)

MS Office Suite

Job description

Overview

About Route 92 Medical: Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes.

Purpose Of Job

This position is onsite in our West Jordan, UT facility. It supports Route 92 Medical’s efforts to sustain a best practice Quality System by ensuring compliance to regulatory requirements such as FDA QSR, ISO 13485, and the EU MDR. Ensure all products meet all applicable internal and external requirements from product conception to market release.

Responsibilities

• Receiving and inspection of components, subassemblies, and supplies.
• Scheduling and/or performing equipment calibration and preventive maintenance.
• Manufacturing inspections, sterilization preparation, and product labelling.
• Processing of nonconforming materials / products.
• Processing of device returns.
• Transferring to and from inventory locations.
• General support for other QA functions as needed.

Skills For Success

• Adaptable to a fast-paced environment
• Attention to detail and focus on the identification of potential issues and continuous improvement

Required Education

• High School Graduate or equivalent required
• Associate’s degree in a technical field preferred

Required Experience

• Minimum of 3 years of work experience in the medical device industry specifically working with inspection tools such as calipers, gauges, etc.
• Experience with MS Office Suite required
• Working knowledge of 1385:2016 preferred

Benefits & Perks

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term disability, Critical Illness Insurance, and Accident Insurance.
• Competitive base pay plus corporate bonus program
• Generous paid time off and 16 paid holidays, including a company-wide summer recharge week in July
• 12 weeks of paid parental leave for employees after 90 days of employment
• Monthly cell phone stipend

The actual base pay is dependent on several factors, including, but not limited to, work experience, market data, skills, geographic location, and business needs. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity.