Don't miss this Career Opportunity!
Leading provider of high precision manufacturing products for the Medical Device Industry with multiple facilities both Global and Stateside. This growing world class company is a leader in manufacturing Medical Device and Solutions.
Quality & Regulatory Affairs Manager - Medical Device
MRINetwork is seeking a Quality & Regulatory Affairs Manager
Position Summary of Skills:
- Strong leadership and management skills
- Familiarity with Regulatory Standards, such as: cGMP, FDA, QSR, ISO13485, and Medical Device Directives
- Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison)
- Computer literate (i.e. date-base development, statistical software and analysis, word processing for report generation, etc.)
- Strong negotiation and problem-solving skills
- Excellent communication (verbal and written) skills; ability to lead teams and communicate effectively with multiple levels of the organization
- Supplier auditing skills (i.e. ASQ-CQA, internal/external courses, seminars)
- Able to understand blue prints, tolerance analysis, inspection methods, and related knowledge
- Strong reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems and conflicts
Education and Experience:
- B.S. Degree in related discipline or equivalent experience preferred
- Minimum of 3 years as a Quality Engineer with Medical Device experience in manufacturing operations, with process qualification experience preferred
- ASQ Certification is a plus
The company offers a very attractive benefits package and compensation! Relocation provided!
Company is interviewing today! Please contact me now for more details!
Send your resume to firstname.lastname@example.org or call Kevin Elliott at 817-857-7713 to learn more.