Quality Assurance Specialist II – Medical Devices

Surmodics, Inc.; Eden Prairie (MN); On-site; USD 64,000 - 96,000; Full time

Benefits offered by this job

Bonus program

401(k) with employer match

Tuition reimbursement

Student debt repayment program

Job summary

Surmodics, Inc. in Minnesota seeks a Quality Associate 2 to support quality assurance activities and maintain the quality system for compliance with QSR, ISO, and related requirements. This role emphasizes product release and continuous improvement within Quality and across functions.

The position involves leading CAPAs, supporting supplier quality, assisting in documentation and audits, and contributing to quality metrics and process enhancements for manufacturing and distribution.

Qualifications

• Four-year technical degree with 2+ years in medical device QA
• Proficient in Word, Excel, Access
• Excellent problem solving and communication skills

Responsibilities

• Lead/participate in CAPAs/Nonconformances
• Support Supplier Quality activities
• Assist Quality Engineering in tasks for product/manufacturing operations
• Support release of intermediates and final product for internal/external distribution
• Assist in customer quality system surveys documentation
• Participate in improvement and efficiency projects within Quality and cross-functionally
• Oversee material/product retain management program
• Write and revise documents to ensure compliance
• Support internal audits of quality system processes and packaging

Skills

Problem solving

Communication

Interpersonal skills

Prioritization

Follow instructions

Education

Four-year technical degree

Tools

Microsoft Word

Excel

Access

Job description

Surmodics, Inc. in Minnesota seeks a Quality Associate 2 to support quality assurance activities and maintain the quality system for compliance with QSR, ISO, and related requirements. This role emphasizes product release and continuous improvement within Quality and across functions.

The position involves leading CAPAs, supporting supplier quality, assisting in documentation and audits, and contributing to quality metrics and process enhancements for manufacturing and distribution.