Interested and qualified parties should reply directly to Randy Neal, at rneal@randall-james.com.

Medio Waldt
610 659 3489
_________________________________
Sales Consultant for Miller Heiman
www.millerheiman.com

We bring precision to the Art of Selling.



Our firm has been retained to fill a Quality Assurance Manager (QAM) position for a global leader in medical device manufacturing operations. The Company is a global solutions provider serving the medical industry. With manufacturing operations in the Americas, Europe and Asia, the Company offers rotary die-cutting, lamination, island placement, printing, label affixing, assembly, and packaging. The Company works from initial development through production to market delivery and also provides R&D assistance and prototyping. The Company is an FDA registered facility certified to ISO 9001:2000 and a 3M Preferred Medical Converter. The Company headquarters are in the Dallas-Fort Worth, Texas area.

The following profile has been developed to better evaluate candidates for this key role. This profile describes the preferred experience, background, education and personal attributes of the successful candidate and personal profile developed for this search.

• Must have five to seven (5 – 7) years’ experience with pharma, medical devices or a combination of both.
• Possess solid knowledge of industry applicable FDA, CFR, ISO, and other regulations.
• Medical device regulatory experience or training.
• ASQ certification as an auditor, quality engineer or manager would be a strong plus.
• Lean/Six sigma experience considered a plus; green or black belt certification a strong plus.
• Will have successfully led a Quality team.
• Plant level experience.
• Experience overseeing quality audits.
• Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Industrial Pharmacy, or other Medical discipline or other related field a must. Master’s Degree in one of the above a plus.
• Proficiency in Spanish is a plus.
• Willingness to relocate to the Dallas, TX area. Excellent benefits and comprehensive relocation package is available. Preference will be given to local candidates or candidates that require minimal relocation assistance.