Quality Technician 1

Responsibilities

• Follow internal policies and procedures in compliance with current FDA cGMP regulations, applicable ISO standards and Surmodics internal policies and procedures.
• Quality Control Sampling and testing of raw materials and finished products
• Simple analysis of raw materials and finished products using wet chemistry and basic instrumentation
• Performs finished product testing
• General equipment and lab maintenance
• Quality Assurance
• Assembles and reviews batch release paperwork and device history records
• Inspects and releases intermediates and finished products against material/product specification requirements
• Samples and maintains retains for intermediates and finished products
• Aids with document control and archiving activities
• Metrology
• Reviews calibration certifications for compliance to procedures
• Organizes lab area and prepares equipment for calibration
• Reviews monthly schedule to ensure equipment is calibrated and maintained per schedule
• Receiving Inspection
• Inspects and releases incoming materials against material specification requirements
• Segregates and labels materials per approved procedures
• Samples and maintains retains for raw materials

Requirements

• High School Diploma or equivalent
• Minimum of 1 year full-time work experience, working in a technical or quality support function
• Ability to support a team environment through collaboration, leadership, and work ethic
• Ability to train on simple lab instrumentation such as pH meters, UV-Vis spectrophotometers, moisture analyzers and rheometers
• Ability to train on software programs that support the quality function
• Basic understanding of the Microsoft Office Suite
• Ability to perform statistical mathematical calculations and be comfortable with using a calculator and spreadsheets, and other statistical programs
• Ability to maintain complete and legible documentation
• Ability to follow directions and procedures and have key attention to detail
• Complete work assignments according to deadlines and maintain thorough and clear documentation of daily activities

Qualifications

• Ability to perform statistical mathematical calculations and be comfortable with using a calculator and spreadsheets, and other statistical programs
• Ability to maintain complete and legible documentation
• Ability to follow directions and procedures and have key attention to detail
• Complete work assignments according to deadlines and maintain thorough and clear documentation of daily activities

Skills

• Statistical mathematical calculations
• Documentation maintenance
• Following directions and procedures

Benefits

• Competitive compensation and benefits package
• Includes a bonus program
• 401(k) with employer match
• Tuition reimbursement
• Student debt repayment program

Pay

Targeted Salary Range $42,800—$59,900 USD

Schedule

N/A