Quality Manager

Pivotal Health Solutions is seeking a Quality Manager to join our team in Watertown, SD.  In this role, you will be responsible for developing, implementing, and maintaining a comprehensive quality management system to ensure that all products and processes meet internal standards and regulatory requirements. This role oversees quality assurance and control activities, drives continuous improvement initiatives, and works cross-functionally with operations, engineering, and leadership teams to promote a culture of quality and compliance.

Essential Job Duties & Responsibilities

• Develop, manage, and maintain expertise on quality system policies, procedures, and standards in accordance with company goals, US FDA, EU MDR, ISO 13485, ISO 14971, and other relevant regulations. Manage Documents and Records and process, and approve, changes in documents.
• Manage Document and Record Controls, and update and approve procedure changes through the change process.
• Oversee inspection processes for incoming materials, in-process production, and finished goods. Manage nonconforming, supplier qualification and re-evaluation, and critical parts processes.
• Manage nonconformances, supplier qualification and re-evaluation, and critical parts processes. Lead vendor corrective action initiatives ensuring business needs are met.
• Lead root cause analysis and corrective/preventive action (CAPA) for non-conforming materials, customer complaints, and process deviations.
• Monitor quality trends and implement and monitor key quality performance indicators (KPIs) and drive improvements across departments.
• Prepare Management Review report; Conduct Management Review, internal and external audits; ensure readiness for ISO, Notified Body and other regulatory audits.
• Collaborate with engineering, manufacturing, and supply chain teams to improve quality, reduce waste, and resolve issues.
• Train and develop team members on quality practices, procedures, and continuous improvement tools. Train and develop employees' site-wide on quality system requirements, changes and where needed to address quality issues.
• Provide feedback to engineering during development projects, review change ECOs for accuracy and impact to quality system and regulatory requirements.
• Maintain accurate quality documentation, records, and reports for compliance and traceability.
• Lead quality meetings, communicate quality metrics, and ensure alignment with business objectives.
• Performs other duties as assigned

Job Qualifications 

• Bachelor's degree in Quality, Engineering, Manufacturing, or related field (or equivalent experience).
• 5+ years of experience in quality management or a similar role in a manufacturing environment.
• Knowledge of quality management systems (e.g., ISO and regulatory requirements.
• Strong understanding of quality system management and quality assurance practices.
• Proficient in root cause analysis, CAPA, document control, vendor qualification, and auditing
• Excellent leadership, communication, and problem-solving skills.
• Proficiency in Microsoft Office applications including Excel.
• Ability to manage multiple priorities and work collaboratively in a fast-paced environment.

Benefits

• Pivotal Health Solutions offers a complete benefits package including 401K, paid time off, paid holidays and healthcare benefits.

To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily.   The requirements listed above are representative of the knowledge, skills, and/or ability required.   Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.