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Surmodics, Inc. · 1 day ago

Senior Quality Technician

Eden Prairie, MN

Full-time

Onsite

Mid, Senior Level

$56K/yr - $78K/yr

5+ years exp

Surmodics, Inc. is focused on developing medical devices to meet unmet clinical needs through advanced technologies and manufacturing capabilities. The Senior Quality Technician will support the quality system by driving continuous process improvement and collaborating with Operations and R&D on product development processes and quality initiatives.

BiotechnologyChemicalHealth CareManufacturingMedical Device

Responsibilities

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

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

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

Qualification

CGMP knowledgeISO standards experienceQuality AssuranceMetrology equipment useStatistical calculationsMicrosoft Office SuiteTeam collaborationDetail orientedDocumentation review

Required

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

Benefits

Bonus program

401(k) with employer match

Tuition reimbursement

Student debt repayment program

Company

Surmodics, Inc.

Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic (IVD) immunoassay tests and microarrays.

Founded in 1979

Eden Prairie, Minnesota, USA

201-500 employees