Quality Associate 2

Surmodics•Eden Prairie, MN

12d

About The Position

The Quality Associate 2 performs quality assurance activities that support operations and product release, and contributes to maintaining and improving the overall quality system. The role helps ensure compliance with Quality System Regulations (QSR), ISO, and other applicable requirements.

Requirements

Four-year technical degree and at least two years of experience in the medical device industry, or at least ten years of experience in a Quality-related field in the medical device industry.
Proficient computer skills, including Microsoft Word, Access, and Excel.
Excellent problem-solving skills.
Ability to read and follow detailed instructions.
Ability to generate detailed instructions.
Excellent written and verbal communication skills.
Excellent interpersonal skills.
Ability to prioritize activities amid competing demands from multiple sources.

Responsibilities

Lead or participate in CAPAs and nonconformances.
Support Supplier Quality activities.
Assist Quality Engineering with assigned tasks supporting product and manufacturing operations.
Support release of intermediates and final products for internal and external distribution.
Assist with customer-requested documentation, including customer quality system surveys.
Participate in improvement and efficiency projects within Quality and cross-functionally.
Oversee the material and product retain management program.
Ensure quality procedures, processes, and systems are standardized throughout the business and implemented consistently and correctly to comply with internal requirements and external regulations.
Write and revise documents to ensure compliance with internal requirements and external regulations.
Support internal audits of quality system processes, manufacturing areas, and documentation, as assigned.
Support Quality leadership in managing external customer and regulatory audits.
Develop and present training material for new or changing processes, as required, to ensure compliance with procedures and regulations.
Serve as Quality Event Coordinator for nonconformances, CAPAs, and complaints, assisting with completion and review of investigations and records for content, accuracy, and completeness.
Assist in developing and maintaining quality system metrics.
Provide insight into statistical trends using quality system data and help create system solutions for quality system issues.
Ensure quality system documentation and record-keeping activities are completed in compliance with established procedures and work instructions.
Perform Document Administration activities in the eQMS software.
Coordinate and archive quality records.