Final Release Specialist

Teleflex • Jaffrey, NH

1d

About The Position

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.Position SummaryThis position is a support role with a focus on Final Release Documentation Review.

Requirements

• High School Education/GED or equivalent work experience
• Strong knowledge of cGMP/GDP required
• Minimum of 2 years of working in a Medical Device manufacturing environment in a Quality role required
• Basic computer and math skills, knowledgeable in Microsoft Office required
• Strong attention to detail; ability to read and interpret prints, procedures and specifications and demonstrate the ability to be thorough and accurate
• Excellent verbal and written communication skills
• Must work well in a team environment
• Ability to adjust to changing priorities and responsibilities
• Knowledge of SAP system preferred; ability to learn SAP system required
• Consistent lifting: 5 - 20 lbs. necessary/ Max = 40 lbs.
• Able to work over-time if required
• The hours of this position are typically within those of 1st shift but are dependent upon the needs of Manufacturing (i.e. starting prior to 7:00am and/or ending after 3:00pm).

Nice To Haves

• Familiarity with ISO 13485 preferred

Responsibilities

• Providing Quality Assurance support to the Device and Extrusion manufacturing areas by conducting full documentation reviews of Device History Records (DHRs)
• Completing transactions in the SAP system, including the generation of Certificates of Conformance (COCs)
• Generating Certificates of Analysis (COAs) and inspection reports
• Verifying packaging and labels
• Entering data into computer databases including SAP system
• Generating and providing DHR Error Rate reports
• Scanning of documents into an electronic file storage database
• Filing, labeling, and staging of documents

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees