3rd Shift Quality Technician

Founded in 1998 and headquartered in Lexington, Massachusetts, Tepha is currently seeking a Quality Technician (3rd shift: 11:00 pm until 7:30 am) with the ability to perform multiple tasks within the Quality organization, including product and label inspection and mechanical testing of fiber.

Duties & Responsibilities

• Perform incoming, in-process and final product inspections
• Complete lot history records using good documentation practices
• Assist Quality Engineering with process and product validation testing
• Perform sampling of water or product for outside biological testing
• Create and/or approve quality inspection documents
• Input data into Quality databases
• Input data, manage spreadsheets and prepare reports as assigned in MS Office

Knowledge, Skills & Abilities

• A minimum of a high school diploma. ASQ certification, CQT or CQI is highly desirable.
• A minimum of 3-5 years in a Quality function, preferably in the medical device industry.
• Mechanical inspection experience
• Well organized with good recordkeeping skills
• Ability to read and understand engineering documentation
• Ability to work well with others and to communicate effectively

Additional Preferred Skills

• Knowledge and good comprehension of FDA’s Quality System Regulation (QSR) and ISO 13485 and/or ISO 9001 (current versions) is desired
• Familiarity with PC based software for data entry and report generation
• Experience using MTS or Instron for physical destructive testing

Please note, this is an office-based position in Lexington, MA and we are seeking someone who can work our 3rd shift which runs from 11:00 pm until 7:30 am.

At Tepha, we strive to maintain the cultural aspects that make us special as our organization continues to evolve. We offer unmatched scientific technology, stimulating work experiences, passionate colleagues and Greater Boston’s most competitive summer bocce league.

Sound good? We invite you to click ‘apply’ and begin a conversation with us. #Tepha

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Tepha Medical Devices about our openings. All resumes submitted by search firms/employment agencies to any employee at Tepha via email, the internet or in any other form and/or method will be deemed the sole property of Tepha, unless such search firms/employment agencies were engaged by Tepha and a valid agreement with Tepha is in place. In the event a candidate who was submitted outside of the Tepha agency engagement process is hired, no fee or payment of any kind will be paid.