Senior Quality Assurance Engineer

ALKU’s senior management team has over 70 years of experience providing highly customized and niche-focused consulting solutions. What sets us apart? Specialized knowledge and experience. Each division employs dedicated teams of account managers and recruiters who focus on a single specialty – ensuring an unmatched depth of expertise within our chosen niches. It takes specialized experience to identify the right talent, and ALKU delivers. Access to top professionals.

Looking for a Sr. Quality Engineer to ensure a large tech transfer project is delivered in compliance with both internal and customer specifications.

* Apply engineering and quality principles in support of manufacturing * Review customer quotes for overall quality requirements * Determine inspection methods/instructions and incorporate them into the manufacturing process * Outline and write measurements for manufacturing CMM operations * Design in-process gauging to be used by manufacturing and inspection groups * Establish and maintain plant and Company-wide quality procedures * Adjust and prioritize work to meet deadlines while maintaining quality standards * Consult with manufacturing engineers in resolving quality-related issues * Establish and maintain a system that triggers effective corrective action * Follow-up on all internal and external corrective action responses * Conduct training on topics of customer and Company SOPs * Project a positive and professional image of the company and of management to employees at all levels * Additional functions and requirements may be assigned by management staff as deemed appropriate.

* Quality systems * GMP regulations * Problem solving and 8D * Statistical Process Control (SPC) **EDUCATION AND WORK EXPERIENCE:** * Harmonized core technical skills: * Metrology * Blueprint / GDT * Manufacturing operations * FDA/ISO regulations **Harmonized core education and experience:** * Associate’ s degree and one to three years of experience in a quality related field or equivalent combination of education and experience. * Orthopedic manufacturing experience preferred * ASQ certification preferred