Nationwide Executive Recruitment From FPC

(F-O-R-T-U-N-E PERSONNEL CONSULTANTS)

You'll Value The Experience!

Our client is a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, non-invasive therapeutic products for a variety of acute and chronic medical conditions.

The company currently employs more than 5,000 people worldwide. The company offers its associates challenging work experiences, a collaborative team environment, and an atmosphere to continually develop your career.

JOB SUMMARY: This role provides leadership for enterprise wide QA/RA Global Supply Chain organization responsibilities for multiple locations in Indiana & Mexico.

ESSENTIAL DUTIES AND RESPONSIBILITIES: – Other duties may be assigned:

· Participates in all Global Supply Chain leadership team activities as the representative for the QA/RA function.

·  Provides overall leadership for the Domestic Manufacturing Operations Quality team.

·  Participates in Management Reviews with Global Supply Chain.

·  Provides insight on Supplier Quality Systems and supplier quality performance to supplier quality leader.

·  Insures QARA Manufacturing Oversight.

·  Responsible for QARA Process Improvement within Global Supply Chain.

·  Participates in development of business metrics.

·  Ensures appropriate controls (key metrics) are defined, implemented and satisfactorily completed for all manufacturing operations.

·  Provides Global Supply Chain and Platform Support.

·  Participates as a Product Action Committee (PAC) Representative.

·  Provides support of Due Diligence for Mergers and Acquisitions.

·  Provides leadership for Quality Issue resolution.

·  Drives data analysis of quality performance to identify high priority issues relating to safety, complaints and systemic customer satisfaction.

·  Provides training resources to ensure proper implementation and use of quality tools and procedures as required.

·  Enables rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence.

·  Develops and manages the QARA Domestic Manufacturing Operations Quality budget and resources.

·  Participates in special projects and initiatives, as requested.

SUPERVISOR RESPONSIBILITIES:

·  Manages Quality/Regulatory associates.

·  Provides leadership to direct reports and other associates.

Job Requirements and Qualifications

QUALIFICATIONS:

·  At least 5 years leadership experience (People development, written and verbal communications skills, action/results oriented, impact and influence)

·  At least 3 years experience in manufacturing environment with proven ability to resolve Manufacturing issues

·  Proficient with QSR, Medical Device Directive, and ISO Quality System Standards

·  Excellent analytical decision making and problem solving skills

·  Track record of business and customer orientation

·  Strong business acumen, interpersonal and organizational management skills

·  Quality Systems certifications a plus

EDUCATION AND/OR EXPERIENCE REQUIRED:

·  College degree required, with preference to engineering or scientific disciplines

·  5-10 years of experience in Quality Assurance or Regulatory Affairs, medical device experience preferred

·  Successful record of managing people and projects

·  Previous global experience/responsibility preferred