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