Quality Manager

Position Summary

The Quality Manager is responsible for the planning, coordination, and implementation of Quality Management System (QMS) processes to ensure quality in production and shipping of products, to meet ISO and regulatory requirements and standards, and to support business requirements.

Essential Duties and Responsibilities

• Accountable for effective integration and execution of company and customer, quality assurance and quality control (QA/QC) requirements in new product development, process validation/verification, production, storage and distribution of product in collaboration from the entire company’s Quality Organization. 
• Approves product quality plans, in collaboration with the customer, when applicable.
• Leads production risk analysis and mitigation program, including but not limited to PFMEA.
• Coordinate quality department resource assignment to optimize and assure product quality throughout the project timelines and lifecycle.
• Ensures that team members are meeting goals and timelines, as well as, working with Production team in meeting quality goals.
• Conducts management and employee meetings regarding quality related issues, production issues and procedures related to quality that directly relate to requirements.
• Ensures staff and employees have a clear understanding of customer quality requirements.
• Reviews technical problems and procedures of all departments and recommends solutions to problems or changes in local or global procedures.  
• Accountable for customer interface with quality aspects of product qualification, quality planning and specification compliance related matters.  Allocates Quality Staff as appropriate.
• Collaborates with all department managers and senior staff to ensure the quality processes are running efficiently and effectively.
• Responsible for the Quality Management System (QMS) maintenance and development.  Lead, support and delegate quality system improvement programs and initiatives in collaboration with the entire company’s Quality Organization.  Maintain QMS certifications. Ensure the promotion and awareness of regulatory and customer requirements throughout the organization.
• Quality Management System Management Representative.  Manage internal and external quality system audits and communicate results to team.  Lead and coordinate observation corrective action.
• Primary interface with regulatory auditors
• Maintain trend analysis on key quality system effectiveness metrics.  Inform plant leadership team of trends, propose and coordinate action to prevent adverse trends development and improve performance.
• Schedule and conduct site Management Review Meetings.
• Owner of corrective and preventive action (CAPA) system.   Track CAPAs for timeliness of completion, implementation and effectiveness.
• Work with plant and company’s leadership team to establish operational objectives and goals. Monitor progress to ensure goals are achieved.
• Owner of complaint management system. Track, assure resolution, and respond to customer complaints or customer satisfaction issues.
• Owner of ERP quality modules, responsible for content and content maintenance.
• Owner of Document Control/Management System, including: specifications, engineering changes, quality records, QMS documents, etc.
• Owner of equipment calibration and maintenance.
• Accountable for procedural compliance with facility and manufacturing pest controls, environmental controls and microbiological analysis and control.
• Lead and manage quality management system team project meetings, delegate tasks, prioritize activities and manage resources.
• Lead and manage direct reports while fostering personnel development.
• Adheres to the Quality Policy and Core Values of the company.
• Other duties as assigned by Plant Manager and/or Director of Quality.

This job description indicates the general nature and level of work, duties and responsibilities expected of the incumbent.  The incumbent may be asked to perform other duties as required.  The job description may be changed if needed as determined by the Company.

Required Competencies, Skills and Experience

• Personal knowledge and experience with regulatory compliance, Audits, CAPA Submissions and IQ, OQ, PQ submittals.
• Excellent problem solving & root cause analysis skills are required.
• Interpersonal communication and project management skills a must.
• Strong leadership skills that inspire team confidence and respect while motivating team members in a creative and effective manner.
• Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability.
• Strong understanding of ISO 9000, ISO 13485 and FDA QSR/cGMP quality standards.
• Must be extremely detail-oriented with respect to documentation and communication.

Education and Job Experience Requirements

• Minimum 7 years of proven experience in a Quality Management role, responsible for overall Quality Systems in the Medical Device and or Pharmaceutical Delivery industries or 10 years of experience as a QE supporting QMS activities.
• Plastics experience preferred
• Understanding of statistics required
• Six Sigma certification preferred
• BS degree in engineering or related discipline desirable but not required
• MS Degree a plus

Work Environment and Physical Demands

• Subject to intermittent and changing noise levels from operating machines.
• Physical hazards from moving equipment and machine parts
• Breathing fumes, dust, and mist
• Skin exposure to oils and cutting fluid.
• Stand, walk, push, pull, reach overhead and bend to the floor.
• Visual acuity, dexterity and accuracy as needed to operate testing equipment or gauges.
• Exert up to 10 to 20 pounds of force constantly to move objects.
• Exert 25 to 50 pounds of force frequently.
• Exert 50 to 100 pounds of force minimally.
• Sedentary, office environment; frequent exposure to manufacturing plant floor requiring the use of personal protective equipment (e.g., ear plugs, safety glasses, etc.) and following good manufacturing practices.
• Normal manufacturing and clean room environment.

The work environment and physical demands detailed above are representative of those encountered while performing the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.  All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.