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

DESIRED

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

DESIRED