Manager, Quality Engineering Product Surveillance

Scorpion Therapeutics; Marlborough (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Lead Quality Engineering Product Surveillance to elevate product quality in a biopharma manufacturing setting. You will investigate issues, drive CAPA, and partner with Engineering, Manufacturing, and Customer teams to resolve complex quality challenges.

The role emphasizes complaint management, root cause analysis, and continuous improvement within a customer-centric framework. Travel/work setup details are not specified.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 7+ years in Quality Assurance with at least 3 years in leadership.
• Deep knowledge of ISO 9001, complaint management, root cause analysis, and QMS.
• Experience with electronic quality management systems, audits, and cross-functional stakeholder engagement.

Responsibilities

• Managing complaint handling systems.
• Leading cross-functional investigations.
• Implementing CAPA.
• Analyzing complaint metrics.
• Fostering a culture of accountability and operational excellence.
• Collaborating with Engineering, Manufacturing, and Customer teams to resolve complex quality challenges.
• Maintaining ISO 9001 compliance.
• Focus on complaint investigation, CAPA, root cause analysis, and continuous improvement in a biopharma production setting, with an emphasis on customer-centric quality resolution.

Skills

Quality Assurance

Leadership

Root Cause Analysis

ISO 9001

QMS

Complaint Management

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Salesforce

Job description

Role

Lead Quality Engineering Product Surveillance to enhance product quality, investigate issues, and drive continuous improvement within a biopharma manufacturing context.

Key Responsibilities

• Managing complaint handling systems.
• Leading cross-functional investigations.
• Implementing CAPA.
• Analyzing complaint metrics.
• Fostering a culture of accountability and operational excellence.
• Collaborating with Engineering, Manufacturing, and Customer teams to resolve complex quality challenges.
• Maintaining ISO 9001 compliance.
• Focus on complaint investigation, CAPA, root cause analysis, and continuous improvement in a biopharma production setting, with an emphasis on customer-centric quality resolution.

Requirements

• Bachelor's in Engineering, Life Sciences, or related field.
• 7+ years in Quality Assurance with at least 3 years in leadership.
• Deep knowledge of ISO 9001, complaint management, root cause analysis, and QMS.
• Experience with electronic quality management systems, audits, and cross-functional stakeholder engagement.

Preferred

• Proficiency with business software including Salesforce.
• Strong communication and technical writing skills.

Additional Details

Work setup and travel details are not specified.