Job Type
Full-time
Description
Job Description - Quality Manager
DEPARTMENT: Quality Control
JOB TITLE: Quality Manager
REPORT TO: Director of Quality
SUMMARYThe 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
DESIREDPHYSICAL 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
