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