QA Manager

Scorpion Therapeutics; United States; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics, a United States-based medical device/software company, is seeking a Quality Assurance (QA) Manager to uphold FDA, EU, ISO 13485:2016, and MDSAP standards across the quality system.

You will oversee document control, training, complaint management, and post-market activities, lead investigations into nonconformities, support audits, and drive continuous improvements with cross-functional teams.

Qualifications

• Bachelor's degree and 7+ years QA experience in regulated industries.
• Preference for SaMD experience; strong knowledge of 21 CFR 820, ISO 13485, MDSAP.
• Proven leadership and cross-functional collaboration skills.

Responsibilities

• Develop, update, and review quality documentation.
• Lead investigations into nonconformities and CAPAs.
• Support internal and external audits.
• Track QMS performance metrics and identify improvements.
• Participate in risk assessments and process enhancements.

Skills

Leadership

Cross-functional collaboration

Regulatory compliance

Root cause analysis

Education

Bachelor's degree

Job description

Quality Assurance (QA) Manager

Role: Quality Assurance (QA) Manager within a medical device/software company, focusing on maintaining compliance with FDA, EU, ISO 13485:2016, and MDSAP standards.

Primary objectives include overseeing Document Control, Training, Complaint Management, and Post-Market activities to ensure product safety, regulatory adherence, and quality system robustness.

Responsibilities

Responsibilities encompass developing, updating, and reviewing quality documentation; leading investigations into nonconformities; supporting audits; tracking QMS process performance; implementing process improvements; and participating in risk assessments.

Qualifications

Qualifications: Bachelor's degree, at least 7 years of QA experience in regulated industries (Medical Devices or Pharmaceuticals), with a preference for SaMD experience; deep understanding of 21 CFR 820, ISO 13485, and MDSAP; proven leadership and cross-functional collaboration skills.

Preferred Skills

Preferred skills include expertise in root cause analysis, process improvements, and navigating change in dynamic environments.

High-Value Specifics

Medical Device/Software (SaMD) focus, QMS, regulatory compliance, audit readiness, risk management, and cross-functional stakeholder engagement.

Work Setup

U.S.-based, onsite/hybrid, with legal work authorization required.