Manager, Quality Engineering Product Surveillance

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.