Quality Manager

Description

Job Description – Quality Manager

DEPARTMENT: Quality Control

JOB TITLE: Quality Manager

REPORT TO: Director of Quality

• SUMMARY
• The Quality Manager is responsible for the Quality Systems and Inspection at GCM.

JOB RESPONSIBILITIES:

• •Develop company strategy to ensure product quality is acceptable with appropriate and demonstrable data
• •ISO9001:2008, ISO13485:2003 and ITAR certification and compliance
• •Guide company in additional strategic certifications
• •Internal Audit Schedule
• •Coordinate and present Management Review Meetings in accordance with ISO requirements
• •Ensure review and timely action with customer issues, complaints, or rejects
• •Effective and timely communication with all departments with regard to product quality and customer standards
• •Communicate and track Customer Requirements
• •All customer compliance for quality reporting, certifications, and capability analysis
• •All customer audits
• •Document IQ, OQ, PQ for all equipment and “critical processes”
• •Optimization of customer satisfaction through improved operations
• •Target 100% customer lot acceptance and 100% on-time delivery

• •Implementation of productivity and quality metrics to minimize costs and enhance efficiency
• •Effective planning and layout of workflow, equipment, and operations
• •Recruiting, hiring, coaching, and developing staff
• •Job descriptions, goals and objectives, one on one and team communications, etc.

• •Developing and optimizing efficiency of workforce (direct labor as a percentage of sales)
• •Budget and contingency planning
• •Ensures adherence to annual budgets

• •Safety and OSHA compliance in your department
• •Improvement of quality by researching best practices and identifying new technology, skills, and processes
• •5S, DMAIC process, Kaizen, etc.
• •Support and enhance sales process
• •Recruit, train, supervise, and evaluate department staff
• •Internal Auditor for ISO9001:2008. ISO13485:2003
• •Must be a team player as measured by his/her peers
• •Performs other related duties assigned

QUALIFICATIONS AND SKILLS:

REQUIRED

• •10 to 15 years of progressive operational and management experience
• •Relevant industry experience
• •Proven track record in the management of quality assurance

DESIRED

Bachelor’s degree

PHYSICAL REQUIREMENTS:

Sitting/Standing/Walking

• •Approximately 50% is spent seated at a desk, working on the telephone or at a computer terminal
• •Approximately 50% is spent bending, squatting, standing, or moving about the work area
• •Frequently lifts, carries, or moves objects weighing up to 25 lbs. and occasionally 50 lbs.
• •Must have ability to use hands to finger, handle, or feel
• •Must have ability to frequently sit, stand, walk, reach within hands and arm’s length, stoop, kneel, and crouch
• •Must have ability to sit or stand for extended periods of time
• •Must be able to wear required Personal Protective equipment (PPE) for extended periods of time
• •Must show proficiency in the set-up and operation of all necessary equipment

Speaking/Hearing

• •Ability to speak read and write English fluently
• •Clear diction, correct grammar and acute haring are necessary for effective communication with clients, vendors, management, and other employees

Vision

Corrected vision close to 20/20 is necessary to effectively use computer screens, read reports and responding to correspondence and emails

Working conditions are normal for a manufacturing/office environment. Work may require occasional weekend and/or evening work

Requirements

QUALIFICATIONS AND SKILLS:

• •5 years of experience in Quality Management
• •CAPA, QIP, 5 why and strong problem-solving skills
• •Comfortable with training, employees, co-workers, suppliers in a positive and professional manner
• •Auditing certificate -ISO preferred
• •Supplier experience – management, monitoring, and auditing
• •5 or more years of experience with auditing both internal, customer and external requirements
• •Good knowledge of ISO 13485, ISO 9001 and other relevant specifications
• •Understanding of industry practices and common manufacturing
• •Results orientated, organized, resourceful with high initiative and problem-solving skills, resourceful with high initiative and enjoys working is a fast-paced environment
• •Knowledgeable skills with excel, word, PowerPoint, outlook and Solidworks (is preferred)
• •Experience managing and/or working within a Complaints Management system, per ISO 13485:2016 and 21 CFR 820.198
• •Experience investigating, writing, and reviewing deviation and nonconformance reports, CAPA, and Change Requests
• •Experience in SPC with Minitab

REQUIRED

• •10 to 15 years of progressive operational and management experience
• •Relevant industry experience
• •Proven track record in the management of quality assurance
• •Certificate of ISO 13485 or AS9100 Lead Auditor

DESIRED

Bachelor’s degree