Quality Manager

GCM Medical and OEM, Inc.•Union City, CA

47d•Onsite

About The Position

The Quality Manager is responsible for the Quality Systems and Inspection at GCM. This role involves developing company strategy to ensure product quality is acceptable with appropriate and demonstrable data, guiding the company in additional strategic certifications, and managing internal audit schedules. The Quality Manager will coordinate and present Management Review Meetings, ensure review and timely action with customer issues, complaints, or rejects, and maintain effective communication with all departments regarding product quality and customer standards. This position also involves communicating and tracking customer requirements, ensuring all customer compliance for quality reporting, certifications, and capability analysis, and managing all customer audits. Additionally, the role requires documenting IQ, OQ, PQ for all equipment and critical processes, optimizing customer satisfaction through improved operations, and targeting 100% customer lot acceptance and 100% on-time delivery. The Quality Manager will implement productivity and quality metrics, plan workflow, equipment, and operations, and manage staff through recruiting, hiring, coaching, and development. This includes creating job descriptions, setting goals and objectives, and facilitating one-on-one and team communications. The role also focuses on developing and optimizing workforce efficiency, budget and contingency planning, ensuring adherence to annual budgets, and maintaining safety and OSHA compliance. Continuous improvement is key, involving researching best practices and identifying new technology, skills, and processes, utilizing methodologies like 5S, DMAIC, and Kaizen. The Quality Manager will also support and enhance the sales process, recruit, train, supervise, and evaluate department staff, and act as an Internal Auditor for ISO9001:2008 and ISO13485:2003. The role requires being a team player and performing other related duties as assigned.

Requirements

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

Nice To Haves

Bachelor’s degree
Auditing certificate -ISO preferred
Solidworks (is preferred)

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