ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develops and executes plans to establish internal manufacturing.
Implements departmental plans and regularly updates management on progress.
Reports and analyzes the department performance on production volume, cost and quality.
Plans and maintains department resources: people, equipment, and materials, to ensure on-time attainment of production and service requirements, at the best cost, and highest quality.
Ensures compliance with all ISO, FDA, and Quality System requirements.
Initiates corrective or preventative actions when out of compliance. Proactive in identifying and implementing quality improvements.
Identifies and implements Cost Improvement programs.
Responsible for salary administration. Conducts performance appraisals and development plans for their direct reports. Coaches and counsels members of the teams to improve results.
Responsible for positive employee relations. Acts as a liaison between employees and management and is responsive to all employee concerns in an efficient and prompt manner. Identifies ways to improve employee relations the process through direct employee involvement. Promote positive employee morale by exhibiting and using good interpersonal skills.
Responsible for developing departmental procedures, work instructions, and safety procedures.
Ensures that employees are appropriately trained and in compliance with all procedures, and that all training is documented.
Sets goals with team, monitors key metrics, and identifies opportunities for improvement.
Assist and provide technical support on project teams to improve production quality, pursue new ideas, and launch new products.
Participate in long-term strategic planning of the company's manufacturing and service requirements.
Capable of managing multiple manufacturing facilities.
Provide analytical input for complaint handling as required.
Participate in strategic planning for manufacturing requirements for new product development and manufacturing line transfers for internal and outsourced manufacturing facilities.
DESIRED MINIMUM QUALIFICATIONS
Education and experience:
Bachelor's degree in Mechanical, Electrical, or BioMedical Engineering or other related technical degree.
Minimum of 3 years in manufacturing and/or process engineering experience required, however five or more years experience in the medical device, pharmaceutical or other FDA regulated industry is preferred. Previous experience in the Class II disposable device would be a definite plus.
Previous working knowledge in the following areas is preferred:
Total Quality Management
Continuous Improvement techniques
Lean Manufacturing
Six Sigma
Demonstrated leadership experience in a supervisory role is preferred.
Knowledge of FDA regulations and/or ISO standards in a regulated industry is required.
Strong oral and written communication skills are required.
Proficient user of Microsoft Office products including Word, Excel, Power Point, and Project.
Familiarity with Product Lifecycle software, such as ARENA PLM, and MRP/ERP software
Excellent organizational skills.

Please email resumes to edoyon@keypartnersinc.com.