SUMMARY:

 

Responsible for the support and maintenance of the Quality System applicable to SANUWAVE Eden Prairie. The candidate ensures that the products produced meet both external and internal requirements, including regulatory compliance and customer specifications within a highly regulated medical device environment. Responsible for review, approval, and oversight of quality related activities and related documents. Proactively identifies areas for continual improvement of quality processes and overall Quality System. Maintains confidential information, including proprietary company and product information.

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RESPONSIBILITIES INCLUDE:

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Document Control and Records Management

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• Controls of all site-specific quality documents (operating procedures, work instructions, engineering drawings, forms, other)

• Maintains controlled documents and records for security, confidentiality, and ease of use. Files, tracks and/or retrieves archived information on a routine basis. Maintains the archive system for off-site storage so that documents, records, and files can be easily retrieved for audit and review purposes

 

Documents and Record Review

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• Reviews and approves Document Change Orders (DCO) and associated controlled documents prior to release for use, including QC testing instructions, raw material specifications, master forms, procedures describing manufacturing processes through distribution, other

• Performs lot release - reviews product-related records (Device History Record) for completeness and accuracy and conformance to specification and approves product for distribution

 

Issue Management (Nonconformances, Deviations, CAPA, Complaints)

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• Reviews and approves manufacturing planned product deviations and nonconformances and related product/material disposition

• Collaborates with subject matter expert on CAPA investigation, Corrective and Preventive Actions, and assesses CAPA effectiveness                       

• Documents, tracks, and oversees Complaints through resolution

 

Training

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• Interfaces with managers to ensure all Eden Prairie employees are trained and training documented

• Maintains training matrix, records, and files for site employees

 

Supplier Management

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• Maintains Approved Supplier List (ASL) and supplier files

• Ensure product materials are purchased exclusively from approved suppliers

• Reviews any Quality Inspections records for incoming product/material

• Initiates and tracks Supplier Corrective Action Requests (SCAR) and collaborates with supplier to resolve issue

 

Other

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• Tracks and trends Key QMS subsystems; maintains and reports metrics

• Conducts QA review and approval of Validation Protocols and Reports (product, process, software)

• Performs other QA duties as assigned

 

Qualifications:

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• Bachelor's Degree in Life Science, Engineering, or other relevant field preferred

• 3+ years of working quality experience within the medical device industry

• 3-5 years’ experience in a GXP regulated field or function, such as in the pharmaceutical industry

• Experience working with 3rd party vendors/suppliers

 

Knowledge and Skills:

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• Strong knowledge of quality assurance and quality systems principles in a highly regulated industry (preferably medical devices, tissue-based products experience a plus)

• Working knowledge of FDA and ISO regulations / standards, including ISO 13485 and 21 CFR 820

• Knowledge of EU Medical Device Directive (MDD), Medical Device Regulations (MDR), and Medical Device Single Audit Program (MDSAP) a plus

• Good written and oral communication skills internally and externally; ability to communicate quality issues, articulate requirements clearly and effectively; and respond to inquiries in a prompt and courteous manner

• Able to successfully motivate compliance and collaboration among staff and exercise judgment within defined procedures

• Comfortable in a small and changing, dynamic company environment

• Willing to improve or develop procedures where they may not have existed before

• Strong cross-functional relationships and team attitude

• Exceptional attention to detail with high degree of focus

• Auditing experience preferred

• Proficient in Microsoft Office applications, including Word, PowerPoint, Excel, Teams

• Familiar with ERP software (such as NetSuite)

 

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SANUWAVE is an Equal Opportunity Employer

 

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Please email your resume to recruiting@sanuwave.com and include the title of the job in the subject line.  Qualified applicants will be contacted.