Executive Director Quality Assurance/Regulatory Affairs
Chicago, IL
$170,000 to $195,000 + bonus + relocation
A multi-national multi-billion dollar Medical Device company seeks an experienced Medical Device Quality Assurance Executive with a strong background leading soup-to-nuts Quality Assurance on a large-scale. This newly created opportunity will be responsible for leading all Quality operations for a multi-billion dollar business across multiple sites. You will also get the opportunity to broaden your background by taking over supervisory scope of the Regulatory Affairs function. Your success will be key to the company’s success in reaching their 5-year goal to quadruple their sales!
High-energy results-oriented Quality Assurance Executive Leaders seeking new challenges as a key member of a new management team. Apply here for an opportunity with one of the industry’s oldest and respected organizations. This opportunity has full Quality Assurance accountability for multiple sites, and representation for all Regulatory interactions. Your team of Quality and Regulatory Director’s will rely on your drive to continue to support a robust new product pipeline, and help them navigate through a new company culture and Senior Management team at Headquarters.
Requirements
- Extensive experience in the Medical Device Industry is required; capital equipment &/or electromechanical experience preferred
- Must possess a strong leadership track record, proven management competence under extreme conditions.
- An overall well-rounded Quality Operations/Quality Systems knowledge as per the FDA QSR’s and experience interacting directly with FDA is also required.
- Minimum B.S. Degree is required. Engineering or Science degrees are strongly preferred. MBA and exceptional presentation skills are also strong preferences.
- Must bring the desire and profile to be promoted to the Vice President level!
Senior Director Product Safety and Post-Market Surveillance -- Retained Search
Senior Director Product Safety and Post-Market Surveillance
Chicago, IL
$160,000 to $185,000 + bonus + relocation
A multi-national multi-billion dollar Medical Device company seeks an experienced Medical Device Quality Assurance Executive with a strong Product Safety, Complaint Handling & Corrective and Preventative Action background. This newly created opportunity will be responsible for driving significant system and organizational change to Post-Market Product Surveillance programs supporting multiple sites for a growing business currently at over $1 Billion annual sales. This is a change-agent opportunity as an integral member of an entirely new Executive Management team, a real opportunity to make an impact and re-create these systems to a World Class level from the ground-floor!
You will own signature authority and accountability for the Health Hazard Evaluation program, as well as all MDR and CAPA activities for a number of challenging technologies on the market today and in the pipeline for the future. Your challenge will also include leading the improvement of the related electronic tracking systems, ie. implementing a TrackWise program. Additionally you will develop an improved CAPA process, as well as improve and lead the Health Safety program.
Requirements
- Qualified candidates must possess extensive Medical Device industry experience.
- B.S. Degree is required, prefer a Nursing degree or Medical Degree.
- Proven management success in a Medical Device environment, as well as a proven track record of leading improvements.
- You must possess a track record of successfully establishing and managing speedy and effective CAPA programs, as well as assessing the complaint management needs for domestic and international regulatory requirements.
- Specific experience in the area of post-market surveillance, Health Hazard Analysis experience is required.
- Must have proven track record of interacting with regulatory agencies, experience directly interacting with FDA is strongly preferred.
Director Quality Assurance 
