Quality Specialist I

About us: BioTouch is a single-source, national provider for all mission-critical kitting and logistics needs.  We partner with a wide range of medical facilities and healthcare providers to bring a higher level of care to the healthcare delivery.  
POSITION OVERVIEW:  The Quality Specialist I plays a crucial role and is responsible for maintaining and improving the quality of products, ensuring compliance with regulations, and fostering a culture of continuous improvement to provide reliable and safe medical kits to healthcare providers we serve.  Essential Duties and Responsibilities include the following. Other duties may be assigned or requested.ResponsibilitiesJOB RESPONSIBILITIES:
 

• Quality Assurance: Ensures quality assurance processes and procedures are being followed according to specified standards. 
• Regulatory Compliance: Responsible for ensuring that the manufacturing processes adhere to regulatory requirements and BioTouch Standard Operating Procedures and Work Instructions
• Training: Completes training as necessary at the site, documents training, and provides completed training records to global training coordinator
• Corrective and Preventive Actions (CAPA): Assists in the CAPA process as assigned by Quality Manager 
• Documentation: Assists with updating Quality Metrics as assigned
• Inspections and Audits: Completes internal audits per the internal audit schedule and as assigned. 
• Supplier and Vendor Quality Management: May work closely with suppliers and vendors to ensure that the materials and components meet quality standards and specifications. 

Required Skills
QUALIFICATIONS

• College degree (Associates, Bachelor) preferred, or will consider HS graduate with 2 years’ experience in a Quality role specifically in a regulated environment such as medical devices and experience with Quality Management Systems and Medical Device Regulations: CFR 820, ISO 13485
• Proficient in Microsoft Excel and Microsoft Word
• Demonstrated experience in the improvement of manufacturing processes.
• Possesses strong interpersonal and communication skills.
• Ability to work under minimum supervision.
• Ability to manage time and complete daily tasks.
• Demonstrates strong work ethic, integrity, and a high level of attention to details.
• This is a high energy, multifaceted position requiring personal initiative and flexibility.

Competencies:

• Job Knowledge – Understands facets of job, aware of duties and responsibilities, keeps job knowledge current.
• Teamwork/Interpersonal Skills – Builds strong relationship, is flexible/adaptable, works well with others.
• Organization Skills – Information organized and accessible, maintains efficient workspace, manages time well.
• Problem Solving – Strives to understand contributing factors, works to resolve complex situations.
• Leadership - Provides strong leadership, sets a good example, skilled decision maker, motivator, encourager.