• The QA Technician, part of the QA/RA Team located in St. Paul, MN, provides support to all quality-related activities at the facility in accordance with all appropriate quality standards and helps ensure that all national and local QMS requirements are established, implemented, and maintained.
• The requirements listed below are representative of the knowledge, skill, and/or ability required. Individuals must possess proficient interpersonal and communication skills to interact cross-functionally.
• Individuals must also be able to communicate effectively with senior management, Client’s Legal, external resources, suppliers, and other functions as appropriate.
Essential duties and responsibilities:
• Document control process administrator - Document review and processing
• Nonconforming material process administrator - identify, disposition, document, investigate, segregate, etc) potentially nonconforming material, and prepare, maintain, and report metrics
• Lead Internal Auditor of quality management system processes
• Facilitate complaint process working meetings to ensure timely processing of complaint service records
• Support improvement activities across the site. This may include serving as a team member on a process improvement team.
• Perform activities to support commercial operations. This may include inspections, investigations, evaluations, and assessments of products, processes and equipment to assure that appropriate standards of Quality and Regulatory Compliance are met.
• Measure performance of processes and report on process-related metrics to site-specific and global reporting mechanisms. Identify opportunities to improve process performance and collaborate with site leadership to implement improvement plans.
• Support investigations to determine when corrective and preventive actions are required. This may require talking with employees, reviewing written records, inspecting products, reviewing quality procedures and preparing reports.
• Review written records to ensure that appropriate quality activities have been performed and that product meets necessary quality standards.
Education, experience and qualifications:
• Associates Degree in a technical discipline with 5+ years of relative work experience in the medical device or a closely related field
• Ability to evaluate and solve problems rigorously
• Balance multiple priorities and effectively manage time to get things done
• Communicate effectively with people at all levels of the organization
• Ability to use a variety of software systems proficiently such as Agile, JD Edwards ERP, TIMS, Microsoft Office, etc
• Motivate others to do the right thing
• Document work in a concise, appropriate manner using Good Documentation Practices
• CQA (or the ability to obtain within 1 year) preferred