
Transformation Quality Engineer
2 days ago
Job Opportunity:
A unique chance to combine hands-on quality engineering with strategic influence, embedding quality excellence into every stage of a company-wide transformation.
- Key Responsibilities:
- Act as the voice of quality during a major identity refresh, ensuring processes, documentation, and systems align with the new brand image.
- Lead process improvement and cost optimization projects using statistical tools such as Design of Experiments, sampling plans, and root cause analysis.
- Own and guide change controls, risk assessments, and process validations linked to rebrand-driven changes.
- Manage CAPAs, non-conformances, SCARs, and supplier quality activities to maintain product and process integrity.
- Conduct internal and supplier audits and support ISO/FDA regulatory inspections.
- Oversee updates to manufacturing, packaging, and labeling processes to reflect the new brand identity while ensuring full compliance.
- Develop and track KPIs to measure quality performance during and after the transformation.
- Maintain CGMP and EHS standards throughout the transition.
Requirements:
- Degree in Engineering, Science, or a related field.
- Minimum 3 years' experience in a regulated manufacturing environment, preferably medical devices or FDA/ISO 13485-certified industries.
- Strong working knowledge of quality tools (FMEA, DOE, root cause analysis, statistical analysis).
- Excellent attention to detail with proven problem-solving ability.
- Strong communication skills, with the ability to explain technical concepts to non-technical audiences.
- Proficient in MS Office applications (Excel, Word, PowerPoint).
Benefits:
The successful candidate will have the opportunity to work on a high-profile project, leveraging their quality engineering expertise to drive business outcomes.
What We Offer:
A dynamic work environment, collaborative team, and opportunities for professional growth and development.
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