More jobs:
Manager, Quality Engineering Product Surveillance
Job in
Marlborough, Middlesex County, Massachusetts, 01752, USA
Listed on 2026-09-21
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-21
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
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.
- 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.
- Proficiency with business software including Salesforce.
- Strong communication and technical writing skills.
Work setup and travel details are not specified.
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