Quality Engineer

Adecco's client is seeking a Quality Manager responsible for the Quality Systems and Inspection.

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
• 5 years of hands-on experience in Quality Management
• Relevant precision manufacturing industry experience
• Proven track record in the management of quality assurance
• 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; Certificate of ISO 13485 or AS9100 Lead Auditor
• 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
• Bachelor's Degree preferred