Quality Manager at GCM in Union City, CA

Apply Job Type Full-time 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