Job Description

Job Description

Job Description

Description:

POSITION DETAILS

JOB PURPOSE The Quality Manager is responsible for the facilitation and oversight of all Quality Department processes and personnel. The position will take a key leadership role in ensuring customer satisfaction and identifying a driving corrective and continuous improvement initiatives to our product, QMS, and business processes.

DUTIES AND RESPONSIBILITIES • LMA (Leadership, Management & Accountability)

• QMS strategy and adherence
• Oversee the Quality Management System (QMS) strategy and adherence.
• Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
• Oversee and ensure compliance with the ISO 13485, and FDA registration to conform to all applicable laws and regulations.
• Ensure proper training procedures are developed and assigned to appropriate personnel in all departments related to quality.
• Implement root-cause analyses and other problem-solving activities to identify effective corrective actions and process improvements.
• Ensure the quality control resources are adequate, efficient and effective for problem identification, resolution, loss reporting.
• Ensure metrics are established and implemented for monitoring system effectiveness and to enable managers to make sound product quality decisions.
• Analyze customers’ product specifications to establish efficient, cost-effective requirements for ease of manufacture and reproducibility.
• Make equipment recommendations for use in the quality lab; understand and train how to use the equipment to perform quality measures accurately and efficiently.
• Participate in internal and external quality audits.
• Other duties as required.

DIRECT REPORTS

• Quality Inspectors
• Document Control Specialist
• Quality Engineer

QUALIFICATIONS

MINIMUM EXPERIENCE REQUIREMENTS 2+ years managing direct reports; 5+ years of quality/engineering activities in a medical device environment or related manufacturing experience.

MINIMUM EDUCATION REQUIREMENTS BS in Engineering or related experience

REQUIRED SKILLS

• Leadership.
• Management of people, processes, projects.
• Statistical methods (SPC).
• Excellent problem solving skills.
• Ability to lead a team effectively.
• Ability to communicate using a common language understood by engineers, customers and/or executives.
• Excellent oral and written communication skills with an emphasis on listening to others.
• Ability to formulate a plan and execute.
• Visualize what the customer wants and using detail-orientation follow a plan to get there.
• Mathematical and statistical knowledge.
• Exercise good judgment when dealing with people as well as projects.
• Ability to present ideas to larger audiences.
• Ability to delegate when appropriate.

Working knowledge of:

• Management principles.
• General human resources principles.
• Microsoft Office suite.
• Plastics and tooling industry.
• General office equipment, including computers, printers, telephones, copier, etc.
• General manufacturing and office procedures.

PHYSICAL REQUIREMENTS The employee is required to sit, move about, reach, handle, and feel.

VISUAL ACUITY As required, with or without accommodation, for reading written documents, design prints and computer screens.

HEARING ABILITY As required, with or without accommodation, for hearing the telephone and communicating with customers, co-workers and visitors.

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