Quality Manager, Manufacturing Exp & ISO13485 a Must
Join a passionate team! Are you looking to get into a company that you can grow with? This position offers a clear career path for success.
Strong benefit package!
Promotes, develops, implements and oversees compliance of the company quality systems and product assurance program to prevent or eliminate defects in new or existing products. Effectively assuring compliance of customer requirements and regulatory organizations by managing quality policies, standards, procedures, programs and practices while driving and facilitating continuous improvement.
This position offers room for advancement.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manage the Quality Management System to ensure compliance of ISO certification, customer and regulatory organizations.
- Coordinate Registrar and Customer Audits and coordinate the completion of SCARs.
- Coordinate, Conduct and complete ISO, Customer, Regulatory organizations, Internal and Supplier Audits. Train and monitor the Internal Audit Team.
- Strategically plan to achieve quality objectives and maintain company standards.
- Create or modify, control and implement company documentation.
- Interface with all departments to discuss quality related issues.
- Provide positive leadership to maintain high morale as demonstrated by teamwork skills
- Ability to create Process Control Plans
- Ability to disposition scrap/rework/reprocess along customer/internal specifications
- Maintain clear and concise DHR's and interface with customer quality as needed
- Evaluate and implement Supplier Quality Agreements from customer
- Conduct MRB meetings
- Create Management Reviews
- React to customer complaints
- Cooperate with Senior Management and confers with department managers modifications of QMS
- Establish and Implements Quality Culture/Commitments to Quality
Education and Experience:
- Bachelor's Degree in Engineering or equivalent preferred
- 5-7 years of quality and manufacturing experience preferred
- ISO13485/2016 auditor certificate
- Root Cause/CAPA training certificate
- Should possess a familiarity with lean manufacturing
- Must possess excellent analytical and problem solving skills
- Must have strong verbal and written communication skills
Language Skills - Ability to communicate effectively and write concise reports for all levels of employees. Ability to deliver training presentations.
Mathematical Skills - Ability to work with mathematical concepts such as addition, subtraction, fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability - Must possess Conflict Resolution Skills and strong Analytical Skills and Decision Making.
This is an equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.
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