Develop, maintain, and follow proper ISO and AS procedures and GMP requirements.
Develop and implement quality management strategy and plans, including resource, systems, timescales, to support, contribute to, and integrate within, the organization's annual business plan and long term strategy.
Develop and maintain systems to measure performance against established standards. Plan and implement specified projects to be
completed including organizing and leading members of various sections, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers)
Provide guidance in quality engineering expertise in the design, development, installation, validation, and qualification of equipment/product which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment
Monitor and inform/communicate/apply standards created/maintained by external bodies, and integrate within internal quality management systems.
Contribute to executive policy and strategy.
Plan work schedules, expenditures, attend meetings, and prepare monthly reports that re required.
Implement and maintain plant wide calibration system and drawing control/document control system.
Gathering, tracking, and analyzing production data for meetings, business plan, quality trending, etc. (Yield/output/efficiencies).
Research and implement cost reduction projects; Corrective and preventative action investigation and customer contacts to resolution on product issues.
Ensuring that processes needed for the quality management system are documented, implemented and maintained.
Reporting to others in top management on the effectiveness of the quality management system and any need for improvement.
Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
Responsible for the internal audit system and any external audits that are conducted.
Serves as a liaison to external parties regarding matters related to the Quality Management System.
Interprets applicable standards and continually verifies Quality Management System compliance.
Leads investigation into any recalls or Advisory Notices.
Familiarity with quality standards and processes to follow federal, state and local regulations
Understand and apply ISO 13485 to applicable role responsibilities.
Understand and apply AS9100 Clauses to applicable role responsibilities
Understand and apply ISO 14001 Clauses to applicable role responsibilities
Follow requirements of ISO standards to maintain and improve the Quality Management System
ISO 13485 Process Owner of Quality
Education:
Bachelor’s degree or equivalent work experience
Essential Knowledge:
Knowledge of quality principals, ability to work with a computer, an understanding of measuring equipment, a good attitude, a desire to succeed and is not intimated by confrontation.
Must have excellent mathematics, reading and writing skills.
Organizational skills, ability to prioritize daily tasks and work as a team member. Analysis, critical-thinking and problem-solving skills to review systems, find defects and pose solutions to those defects.
Work Experience:
At least five or more years of experience in a quality assurance or quality control position and strong organizational and leadership skills.
Professional experience in production and/or manufacturing, especially working with assembly line processes. Supervision experience is a must
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