Overview
Description of the role : Job Description – Quality Manager in the Quality Control department. Reports 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 experienceRelevant industry experienceProven track record in the management of quality assuranceDESIRED
Bachelor's degreePhysical Requirements
Sitting / Standing / Walking
Approximately 50% is spent seated at a desk, working on the telephone or at a computer terminalApproximately 50% is spent bending, squatting, standing, or moving about the work areaFrequently lifts, carries, or moves objects weighing up to 25 lbs. and occasionally 50 lbs.Must have ability to use hands to finger, handle, or feelMust have ability to frequently sit, stand, walk, reach within hands and arm's length, stoop, kneel, and crouchMust have ability to sit or stand for extended periods of timeMust be able to wear required Personal Protective equipment (PPE) for extended periods of timeMust show proficiency in the set-up and operation of all necessary equipmentSpeaking / Hearing
Ability to speak read and write English fluentlyClear diction, correct grammar and acute hearing are necessary for effective communication with clients, vendors, management, and other employeesVision
Corrected vision close to 20 / 20 is necessary to effectively use computer screens, read reports and respond to correspondence and emailsWorking conditions are normal for a manufacturing / office environment. Work may require occasional weekend and / or evening work
Qualifications and Skills (Continued)
REQUIRED
5 years of experience in Quality ManagementCAPA, QIP, 5 why and strong problem-solving skillsComfortable with training, employees, co-workers, suppliers in a positive and professional mannerAuditing certificate -ISO preferredSupplier experience – management, monitoring, and auditingTravel is required. 3 or more times per year5 or more years of experience with auditing both internal, customer and external requirementsGood knowledge of ISO 13485, ISO 9001 and other relevant specificationsUnderstanding of industry practices and common manufacturingResults orientated, organized, resourceful with high initiative and problem-solving skills, resourceful with high initiative and enjoys working is a fast-paced environmentKnowledgeable 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 820.198Experience investigating, writing, and reviewing deviation and nonconformance reports, CAPA, and Change RequestsREQUIRED
10 to 15 years of progressive operational and management experienceRelevant industry experienceProven track record in the management of quality assuranceCertificate of ISO 13485 or AS9100 Lead AuditorDESIRED
Bachelor's degreeJ-18808-Ljbffr