Job Overview
We are seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our dynamic manufacturing team. In this role, you will be instrumental in ensuring that our products meet the highest quality standards, comply with regulatory requirements, and adhere to industry best practices. Your expertise will help drive continuous improvement initiatives, uphold safety and quality compliance, and support the delivery of exceptional products to our customers. This position offers an exciting opportunity to contribute to a fast-paced environment where quality is at the forefront of everything we do.
Responsibilities
- Develop, implement, and maintain quality assurance protocols aligned with ISO 9001 standards and other relevant regulatory frameworks such as FDA regulations and GMP guidelines.
- Conduct comprehensive quality audits across production processes to identify areas for improvement and ensure compliance with HACCP, CGMP, Lean management, and other industry standards.
- Lead root cause analysis and problem-solving efforts using Six Sigma methodologies to resolve quality issues efficiently.
- Perform detailed quality inspections and control checks throughout manufacturing stages, utilizing GD&T (Geometric Dimensioning & Tolerancing) principles to verify product specifications.
- Collaborate with cross-functional teams including manufacturing, engineering, and regulatory affairs to develop corrective action plans and implement process improvements.
- Maintain accurate documentation of quality systems, audit reports, non-conformance reports, and compliance records in accordance with ISO standards.
- Provide leadership in training team members on quality management practices, regulatory compliance standards, and best practices in quality control.
Qualifications
- Proven experience practicing in an industrial or manufacturing engineering role with a strong understanding of manufacturing processes and quality systems.
- Demonstrated knowledge of HACCP, CGMP, ISO 9001, ISO, FDA regulations, and regulatory/legal compliance standards relevant to production environments.
- Strong analysis skills with experience in conducting quality audits, quality inspections, and root cause analysis using Six Sigma tools.
- Familiarity with GD&T (Geometric Dimensioning & Tolerancing), GxP (Good Practice) guidelines such as GMP (Good Manufacturing Practice), and Lean management principles.
- Excellent team leadership abilities combined with effective cross-functional communication skills to foster collaboration across departments.
- Project management experience with the ability to prioritize tasks efficiently while maintaining attention to detail.
- Certification in Six Sigma manufacturing or related quality assurance credentials is preferred but not mandatory.
Join us in our mission to uphold the highest standards of quality while fostering innovation and continuous improvement! We are committed to supporting your professional growth within a vibrant environment dedicated to excellence in manufacturing and regulatory compliance.
Pay: $81,049.82 - $97,608.38 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
Work Location: In person
