Quality Manager in UNION CITY, California at GCM MEDICAL AND OEM INC

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

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