SUMMARY/PURPOSE
Assures consistent quality of production by developing and enforcing good manufacturing practice (GMP) systems; validating processes, providing documentation and managing staff.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality and customer service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
• Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
• Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
• Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
• Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
QUALIFICATIONS / EDUCATION / EXPERIENCE
Bachelor’s degree with at least 5 years previous quality assurance management experience. Strong understanding of statics, quality equipment, instruments and processes. Good communication and interpersonal skills using tact and diplomacy. Prefer Six Sigma Black Belt certification. Exceptional attention to detail. Must be self directed with leadership qualities.
LANGUAGE SKILLS
Effective communication and report writing skills. Good negotiation skills with customer-oriented attitude. Excellent analytical ability to grasp the key points from complicated details. Good leadership capabilities to lead project to successful completion. Familiarity with tools, concepts and methodologies of quality management.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is frequently required to stand, walk, talk, and hear. The employee is occasionally required to sit; use hands and fingers to grip, feel, peel or control; reach with hands and arms; stoop, kneel, crouch, or crawl, and smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and ability to adjust focus. Eye protection is required.
WORK ENVIRONMENT
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; fumes, chemicals or airborne particles; outside weather conditions and vibration. The noise level in the work environment is usually loud, and wearing hearing protection may be required.
The essential duties, physical demands and work environment characteristics described are representative of those that must be met by an employee to successfully perform the essential functions of this job. If possible, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions where it may not cause undue hardship or safety risks to the company and / or the employee.
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Tagged as: Freelance