At KMC Systems, an Elbit Systems of America company, we spend our days working on exciting and meaningful innovative solutions that protect and save lives.  From providing solutions for our warfighters and commercial pilots, to providing lifesaving medical instrumentation and homeland security technologies, the employees of Elbit Systems of America understand the value of their work and why we do what we do each and every day.  We are looking for extraordinary people to join us in making a difference in the lives of others.

KMC Systems is a leading contract designer and manufacturer of medical devices and instrumentation for OEM’s in the areas of diagnostic, therapeutic, and biomedical products. With more than 30 years of experience, KMC is an ISO 13485 certified and FDA registered firm with expertise in all aspects of medical product development, verification, design for and transition to production. Additional capabilities include flexible turnkey manufacturing, depot repair and full compliance with FDA QSR regulations and GMP practices.

MAJOR JOB OBJECTIVES

Responsible for establishing, implementing and maintaining an integral, efficient and cost-effective company program to assure the quality of our business processes continually produce Quality products and services for our customers. Responsible to assure all processes are Lean, Agile and Flexible and provide “value” to our customers while meeting the applicable regulatory requirements as appropriate. Act as alternate Management Representative for all matters relating to Quality as requested.

NATURE AND SCOPE

Jobs reporting to this position:

• Quality Engineering (I, II, Sr. Principal, and Staff)

PRINCIPAL RESPONSIBILITIES

• Lead KMC Quality Operations such as Quality Engineering staff on manufacturing programs 
• Grow teams with good mix of talent to achieve desired results (high product quality, margins, team morale, etc)
• Work cross-functionally especially with Operations, Engineering, and Manufacturing Engineering to ensure customer requirements are met, and to achieve desired business results.
• Monitor and prepare capital, labor and expense budgets ensuring cost-effective operations
• Significant contribution to Operations Data Monitoring and Analysis.  Provide input to monthly program reviews, periodic Management Reviews, etc.  Influence and enhance current trending and analytics capability.
• Collaborate with KMC Quality System staff to enhance Quality System (SOPs, Forms, Computerized tools) as identified.
• Ensure that quality and reliability standards meet international, federal, and local government legislation, FDA, EU, Health Canada, etc and other pertinent contractual and special customer requirements as specified in Quality Agreements. .

ADDITIONAL RESPONSIBILITIES

• Establish and implement training programs for quality personnel and other interfacing departments.
• Direct the appropriate utilization of statistical sampling and probability methods to insure cost effective utilization of resources while assuring company and customer quality and reliability objectives are met.
• Direct the planning and implementing of projects that evaluate production controls, lot evaluations, and other items warranting investigation that periodically surface with respect to quality and reliability that require senior level attention.  This would include the directing of appropriate failure analysis activities, root cause determinations, interpretation of results and subsequent corrective action activities.
• Review and monitor departmental functions and activities to ensure efficient utilization of manpower and other resources; determine the need for and implement staff reductions or expansions; conduct project meetings to determine status and assign responsibilities and implement changes necessary to improve operating effectiveness.
• Collaborate with Operations and Engineering personnel on all QS processes that interface with those departments such as Deviations, Material Review Board, Change Control, CAPA, Complaints, Nonconforming Material and Failure Investigations
• Promote satisfactory employee relations and adherence to company policy and procedures.
• Provide Leadership to Quality staff to promote career goals, customer satisfaction and excellence in process execution.
• Meet the KMC Quality & Regulatory performance goals as agreed upon with site leadership.
• Other related duties as assigned by senior management.

POSITION REQUIREMENTS

Strong leadership skills are essential.  Excellent communication skills, motivating teams, working collaboratively, and being an agent for change are critical must have attributes.  Looking for an individual that can think differently and instill positive change as needed across the organization.

Must have FDA inspection and ISO Notified Body audit experience.  Must be proficient with all applicable Medical Device regulations (21 CFR 820, 803, 806, Part 7, Part 11, 809, ISO 13485, 14971, IEC 60601, 62304, etc)  Must have experience with Class II, III medical device manufacturing and new product introduction to include design transfer.  Must have a solid command of Medical Device Design Control requirements.

A Bachelor's degree (Masters preferred) in Business Management, Engineering, Healthcare and 10 plus years related experience, to include at least 5 years management experience, to be proficient in the above areas; or an equivalent combination of education and experience.   ASQ or other regulatory certifications a plus.

All your information will be kept confidential according to EEO guidelines.