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Senior Quality Technician

3 weeks ago

Eden Prairie, Minnesota, United States Surmodics Full time

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 Senior Quality Technician is responsible for performing a variety of functions to support the overall quality system. This position may be assigned to one focus area listed below, additional responsibilities may be defined based on business need. The Senior Quality Technician will drive continuous process improvement in quality systems and product development processes. The position receives minimal instruction and supervision. This position collaborates with Operations and R&D on product development processes and supports Quality and/or cross-functional improvement initiatives, CAPA projects and internal audits. This position will perform a lead role in one or more focus areas.

Responsibilities

Follows internal policies and procedures in compliance with current FDA cGMP regulations, applicable ISO standards and Surmodics internal policies and procedures, in one or more of the following focus areas:

Quality Control (% Varies)

•Samples and inspect raw materials against pre-approved material specification requirements

•Inspects sub-assemblies and final product to material specification

•Inspects returned materials and completes affected product disposition

•Segregates and labels materials per approved procedures

•Samples and maintains retains for raw materials and finished products

•Provides inspection results feedback to product or process owner

•Partners with R&D and Supplier Quality Engineering as an inspection SME providing feedback for establishment of component specifications and inspection procedures

•Performs general equipment and lab maintenance

•Conducts nonconformance sorting or testing as required to support product disposition

Quality Assurance (% Varies)

•Assembles and reviews batch release paperwork and device history records

•Prepares and reviews change control documentation

•Assists with record control and archiving activities

•Audits processes to ensure compliance with policies and procedures governing specifications, safety, preventative maintenance, etc.

•Documents nonconformance, performs containment activities, assists in justification and identification of NCR correction and disposition

•Suggests and drives continuous improvement ideas and/or projects to improve QA processes, contributes to implementation

Metrology (% Varies)

•Organizes lab area and prepares equipment for calibration

•Assists in the collection and distribution of equipment requiring calibration for facility

•Contributes to equipment related problem solving

•Reviews monthly equipment calibration schedule to ensure equipment is appropriately calibrated and maintained

Minimum Qualifications


•High School Diploma or equivalent

•Five plus years' full-time work experience, working in a technical or quality support function or three to five years minimum with an Associate degree

•Knowledge/experience with cGMPs, ISO, ASTM, and applicable standards

•Ability to support a team environment through collaboration, leadership, and work ethic

•Familiar with use of metrology equipment such as rulers, digital microscopes, gages, and micrometers

•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

•Detail oriented in both process/inspection and resulting documentation

•Ability to complete work assignments according to deadlines with minimal instructions and supervision

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.

Targeted Salary Range

$55,600 - $77,900 USD