Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.
The Quality Technician 1 is responsible for performing a variety of functions to support the overall quality system. This position may be assigned to one area, or may rotate through each area. The Quality Technician 1 receives detailed instructions and is responsible for carrying out these instructions with varying degrees of supervision, depending on position and task.
Responsibilities
Follows internal policies and procedures in compliance with current FDA cGMP regulations, applicable ISO standards and Surmodics internal policies and procedures.
Quality Control (% Varies)
• 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 (% Varies)
• 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
• Assists with document control and archiving activities
Metrology (% Varies)
• 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 (% Varies)
• Inspects and releases incoming materials against material specification requirements
• Segregates and labels materials per approved procedures
• Samples and maintains retains for raw materials
Minimum Qualifications
• 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
• Ability to review documentation according to defined requirements
• 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
Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.
Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program.
Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.