Job Title: Quality Systems Specialist

Job Description

We are seeking a dedicated Quality Systems Specialist to provide oversight for the development and maintenance of quality programs, systems, processes, and procedures. This role ensures compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. The specialist will interpret policies, regulatory and/or governmental regulations and agency guidelines to assure compliance, and will work directly with operating entities to provide process analyses and oversight on a continuing basis.

Responsibilities

• Act as CAPA Specialist to keep the CAPA portfolio for the Cardiac Surgery Operating Unit and Parker CAPA board on track with detailed timelines.
• Work with CAPA owners to ensure CAPA tasks and phases are completed per timelines and procedural requirements.
• Prepare CS OU and Parker CAPA board agenda and file meeting minutes.
• Prepare quarterly CS OU and Parker CAPA portfolio review and file within meeting quality management review data.
• Work with SMEs to complete the Quality Management Review presentation quarterly.
• Prepare monthly CS OU End-to-End CAPA portfolio review and file meeting minutes and presentations.
• Lead audit and inspection preparation, resolve audit and inspection findings, and liaise with auditing groups and inspectors through all stages of the audits.
• Coordinate legal requests in support of government investigations or litigations.
• Ensure quality assurance programs and policies are maintained and modified regularly.
• Facilitate uniform standards worldwide and enable best practice sharing, fostering the achievement of the company's mission globally.

Essential Skills

• Advanced knowledge of quality systems and compliance.
• Experience with CAPA (Corrective and Preventive Actions) processes.
• Strong cause analysis and critical thinking skills.
• Excellent time management and presentation skills.
• Proficiency in writing problem statements and quality compliance documentation.
• Minimum of 4 years of relevant experience with a Bachelor’s degree, or 2 years with an advanced degree.

Additional Skills & Qualifications

• Experience in the medical device industry.
• Project management skills.
• Capability to work independently under limited supervision.
• Ability to communicate with senior internal and external customers and vendors.
• Experience in providing guidance, coaching, and training to other employees.

Work Environment

The position requires working 40 hours a week, with a minimum of 3 days per week on-site in Mounds View, MN. The work involves a professional office environment and requires adherence to quality standards and procedural requirements. The role may include exchange of information with senior internal and external customers and vendors to achieve objectives and influence decision-making.