Quality Manager - Sandy

Job Details

Description

JOB PURPOSE :

The Quality Assurance Manager ensures compliance to Spectrum Plastics Group (SPG) Core Values, -Customers, Teammates, Future, while fulfilling the needs of the industry and community.

They will direct Sandy's Quality department and provide a structured system that requires delivered part quality meets or exceeds customer expectations;

ensures compliance to and maintenance of ISO 13485 Quality standard certification; and promotes awareness of customer requirements throughout the facility.

Essential Duties and Responsibilities

• Act as a Sandy Management Representative for all Quality Systems matters.
• Has the independent authority, responsibility and access to top management to resolve quality management issues
• Organize, chair, document, and distribute QMS Management Review meetings
• Manage and direct internal audits of quality system and report on Quality System performance to top management
• Establish and maintain Sandy's Quality Management System and comply to SPG corporate Quality policies
• Provide the management team and others with regular reports against quality objectives.
• Direct quality control objectives and ensure that products produced meet required standards
• Oversee and ensure calibration, testing, source inspection, in-process inspection, and final inspection of product
• Direct in-plant control of non-conforming product, including quarantine of product not meeting quality requirements
• Oversee internal and external corrective action processes and ensure that corrective actions are completed in a timely manner
• Respond to customer complaints and resolve issues in a prompt and professional manner
• Coordinate with departmental managers to ensure appropriate, required and accurate collection, retention, storage, and control of quality system documents and records
• Active responsibility in APQP process to review and provide input to new part feasibility
• Ensure that first article inspection, PPAP and other pre-production qualifications are per customer requirements
• Perform other accountabilities as assigned

Responsibility for Work of Others

• Direct supervisory responsibility over Quality direct reports
• Direct temporary employees and other department employees assigned to quality related assignments
• Work closely with other department managers, supervisors and employees to ensure adherence to customer and quality policy manual requirements

Qualifications

QUALIFICATIONS (Education / Experience / Knowledge, Skills & Abilities)

Required :

• Degree in a technical discipline or relevant medical device Quality Management, Quality Engineering or Quality Systems experience
• Three to Five years Quality Management experience in a regulated manufacturing environment preferred
• Excellent English communication skills, both written and verbal
• Strong management and supervisory skills with a focus on teamwork
• Training and experience in ISO 9001, ISO 13485 and / or FDA regulated quality systems requirements
• Training and experience in formal Root Cause problem-solving techniques (8D, 5 why etc.) and lean manufacturing.

Physical Demands

• Regularly required to sit, stand, walk, and move about the facility
• Occasionally required to bend and stoop.

Work Environment

• Works in an office and manufacturing environment
• While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles and noise associated with the extrusion and fabrication manufacturing processes
30+ days ago