Senior Quality Engineer
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The Senior Qulaity Engineer oversees the implementation, maintenance, and compliance of the Quality Management System while supporting organizational goals, regulatory standards, and continuous improvement initiatives. The Senior Quality Engineer acts as a quality lead delegate, drives process optimization using data-driven methodologies, and ensures product and process compliance with global regulatory requirements.
Responsibilities
- Represent the Quality function in site management and act as delegate for the Quality Lead.
- Lead and implement process improvements, cost-saving projects, and quality initiatives using data analysis and quality tools.
- Manage and approve change controls, risk documentation, validation, and procedural updates.
- Lead and provide technical guidance for investigations, CAPAs, NC/NCMRs, and supplier quality issues.
- Conduct and lead internal and supplier audits; support external audits (e.g., ISO, FDA).
- Ensure compliance in product manufacturing, packaging, labeling, and adherence to cGMP.
- Develop and track Quality KPIs aligned with site and global objectives.
- Promote EHS compliance and maintain thorough training and procedural adherence.
Skills and Experience
- Degree in Engineering or a Science-related field.
- Minimum five years’ experience in regulated environments (preferably medical device, FDA, or ISO 13485).
- Strong command of statistical tools, FMEA, and root cause/problem-solving methods.
- Advanced computer proficiency (Excel, PowerPoint, Word).
- Excellent communication skills for technical and non-technical audiences.
- In-depth understanding of Quality System Regulations and related standards.
Consultant
Nathaniel O'Reilly
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