Senior Quality Control Specialist
Probo Medical
Date: 3 weeks ago
City: Tamarac, FL
Contract type: Full time
Description
Probo Medical is a diagnostic imaging sales and service provider that delivers high-quality, affordable healthcare products and services to medical practices around the world. With locations that span across the US, Canada, the UK and parts of Europe, we’ve made it our mission to increase access to healthcare services for patients worldwide. We believe that it starts with reducing healthcare costs and empowering medical professionals to make smarter decisions for their healthcare business. As employees of Probo Medical, we focus on building quality relationships with customers, by empowering our teams to solve problems together and creating long-lasting relationships with our customers. If you have a passion for healthcare and share our common goal to help increase patient access to affordable, high-quality products and services, we encourage you to apply!
The Senior Quality Control Specialist is responsible for executing the daily quality activities in a depot repair environment. Maintains quality standards by approving incoming repairs, in-process work, and finished repaired equipment, recording quality results. Responsible for ensuring that quality documentation and records are in compliance with internal requirements as well as ISO 13485 and applicable FDA requirements. The Senior Quality Control Specialist provides guidance and trains Quality Control specialists.
Essential Duties And Responsibilities
Requirements
REQUIRED EDUCATION AND EXPERIENCE:
The position has no supervisory responsibilities.
WORK ENVIRONMENT
Work is performed in the Quality Control area of Operations.
The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
While performing the duties of the role, the employee is situated in a depot repair environment, working at a bench station in a unique work area, apart from administrative staff. The noise level in the work environment is usually quiet, but it is an active repair space with moving inventory.
PHYSICAL AND MENTAL DEMANDS
The position requires ability to lift, carry and/or move various items up to 20 pounds, while utilizing proper technique.
While performing the duties of this position, the employee is regularly required to sit; use hands and fingers to key, handle or feel; talk or speak; hear, and stand. The employee is occasionally required to stoop, kneel or crouch; bend; reach with hands and arms; and walk. Vision abilities required to perform this job include close vision.
The physical and mental requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
Travel Requirements
Little or no travel required (less than 10%).
Probo Medical is a diagnostic imaging sales and service provider that delivers high-quality, affordable healthcare products and services to medical practices around the world. With locations that span across the US, Canada, the UK and parts of Europe, we’ve made it our mission to increase access to healthcare services for patients worldwide. We believe that it starts with reducing healthcare costs and empowering medical professionals to make smarter decisions for their healthcare business. As employees of Probo Medical, we focus on building quality relationships with customers, by empowering our teams to solve problems together and creating long-lasting relationships with our customers. If you have a passion for healthcare and share our common goal to help increase patient access to affordable, high-quality products and services, we encourage you to apply!
The Senior Quality Control Specialist is responsible for executing the daily quality activities in a depot repair environment. Maintains quality standards by approving incoming repairs, in-process work, and finished repaired equipment, recording quality results. Responsible for ensuring that quality documentation and records are in compliance with internal requirements as well as ISO 13485 and applicable FDA requirements. The Senior Quality Control Specialist provides guidance and trains Quality Control specialists.
Essential Duties And Responsibilities
- Approves incoming equipment by confirming specifications; conducting visual and measurement tests; and quoting any repairs and damage found.
- Approves finished products by confirming specifications; conducting visual and measurement tests; returning repairs for re-work; confirming re-work.
- Documents inspection results by completing reports and logs; summarizing re-work; filling out appropriate paperwork.
- Maintains safe and healthy work environment by following standards and procedures, complying with legal regulations.
- Updates job knowledge by participating in educational opportunities; reading technical publications
- Supports document control and retention
- Supports quality system requirements following establishes procedures and processes.
- Observes and promotes Company standards and policies on safety, quality and productivity.
- Accomplishes quality and organization mission by completing related results as needed.
Requirements
REQUIRED EDUCATION AND EXPERIENCE:
- High School Diploma or equivalent required
- Previous experience working in environment subject to ISO 13485: 2016 Medical Devices
- Five (5) plus years of quality control/technician experience working with medical devices or related mechanical devices/electronics.
- Technical degree preferred
- Experience working in an established FDA Quality System Regulation (QSR-21 CFR Part 820, 21 CFR Part 210/211)
- Good laboratory practice (cGLP) and good manufacturing practice (cGMP) experience
- Attention to detail
- Analytical problem-solving skills
- Integrity and high ethical standards
- Computer competency in MS Office – Word, Excel and Outlook
- Excellent verbal, interpersonal and written communication skills
- Self-starter, and motivated individual who works independently
The position has no supervisory responsibilities.
WORK ENVIRONMENT
Work is performed in the Quality Control area of Operations.
The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
While performing the duties of the role, the employee is situated in a depot repair environment, working at a bench station in a unique work area, apart from administrative staff. The noise level in the work environment is usually quiet, but it is an active repair space with moving inventory.
PHYSICAL AND MENTAL DEMANDS
The position requires ability to lift, carry and/or move various items up to 20 pounds, while utilizing proper technique.
While performing the duties of this position, the employee is regularly required to sit; use hands and fingers to key, handle or feel; talk or speak; hear, and stand. The employee is occasionally required to stoop, kneel or crouch; bend; reach with hands and arms; and walk. Vision abilities required to perform this job include close vision.
The physical and mental requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
Travel Requirements
Little or no travel required (less than 10%).
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