US ISO Specialist

Job Description 

POSITION TYPE:  ​New​ 

POSITION PURPOSE:  To develop, establish, implement, and lead Quality management within Lakeland.  This will include the development and implementation of systems and processes to meet Good Manufacturing Practices (GMP) requirements, Compliance with FDA registrations/certifications, as well as ISO and other certifications required for Lakeland products to conform to various certifications globally.  Coordinate, maintain, and enhance Lakeland’s Quality System to meet or exceed ISO requirements.  Ensure products that reach the customer meet or exceed Lakeland’s quality standards.  Work with procurement and product development to write raw material and finished product specifications and manage incoming inspection and approval.  Investigate root cause of any non-conforming products and work with the appropriate Managers to develop, install, and verify corrective actions to ensure defects/mistakes are not repeated.  Ensure that all corrective actions are effective and acceptable to both Lakeland and the customer.  Work with vendors and customers on corrective actions and any required product specifications.  Monitor and report key performance indicators (KPIs) within the U.S.   

REPRESENTATIVE DUTIES AND RESPONSIBILITIES:   

1. Develop systems and processes to meet GMP requirements, compliance with FDA regulations, as well as ISO and other certifications as required 

2. Develop and implement quality metrics, KPIs, and specifications for suppliers and Lakeland 

3. Conduct data and trend analysis 

4. Coordinate ISO audits 

5. Report to management on performance of the QMS including improvement needs 

6. Direct and coordinate product returns and recalls 

7. Ensure periodic management review meetings 

8. Ensure the investigation of defects, development of root cause analysis, and development of corrective actions 

9. Ensure quality defects are documented, tracked, analyzed, and reported   

10. Ensure procedures are accurately documented for ISO purposes 

11. Work with Manufacturing to improve quality  

12. Work with consultants on cleanroom, chemo, and isolation gowns to assure that Lakeland’s quality control systems meet minimum industry standards. 

13. Formally present root cause and corrective actions  

14. Manage the documentation, maintenance, and enhancement of Standard Operating Procedures and Processes 

15. Collaborate in the development of facility’s key performance indicators and objectives  

16. Ensure timely inspection and calibration of monitoring and measuring devices 

17. Travel (25%) as needed to customers, vendors, and Lakeland locations globally 

18. Take initiative 

19. Successfully work with and communicate with other employees and our outside customers and vendors 

20. Support and uphold the three pillars: Respect, Communication, and Accountability 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:   

Requirements:  Effective and professional communication skills (both written and verbal); Knowledge of standard quality programs and analysis (5S, ISO, Kaizan, etc.);  Skilled in supervision/management of others in multiple locations;  Skilled in SPC; Ability to personally inspect and measure products;  Ability to use and read measuring tape, ruler, yard stick;  Knowledge and ability to formally present analysis and corrective actions;  Knowledge of MS Office;  Ability to record, graph, and report findings;  Take ownership of issues;  Ability to travel internationally 

Preferences:  ISO Auditor certification, Six Sigma training and rating 
 

MINIMUM EDUCATION/EXPERIENCE:   

Education:     ​High School Diploma or GED equivalent​ 

Experience:    2 years ISO Management  

PREFERRED EDUCATION/EXPERIENCE:   

Education:     ​Bachelor's degree from an accredited college or university​ 

Experience:   Quality training/certification;  

REQUIRED LICENSURE/CERTIFICATION/REGISTRATION:   

NA 

WORKING CONDITIONS / EQUIPMENT:   

Could be exposed to high and low temperatures occasionally; Ability to go into warehouse and manufacturing areas as needed; Ability to work on call; Ability to travel as necessary both domestically and internationally; Requires bending and lifting of up to 50 pounds occasionally and 25 pounds on regular basis;  Ability to sit and stand for extended periods of time;  Ability to travel internationally and to other locations