5 Commerc Way
Auburn, NY 13021
Volpi is a privately owned company with locations in Zurich, Switzerland and Auburn, NY USA. Our core competencies are in systems engineering, development, production and life cycle management of customer-specific OEM subsystems. We are at the forefront of optical module development and manufacturing, which enables our industry leading OEM-customers to realize advantages in speed, accuracy, quality, up time and cost with their instruments.
Your main functions:
The primary role of this position is to provide global leadership, direction and hands on involvement regarding quality management system, quality control and quality improvement process for the Volpi Group. This position requires strong manufacturing knowhow in a highly controlled or regulated industry, customer and supplier relations, and a thorough working knowledge of compliance requirements in an ISO 13485 environment. The Director Quality reports to the COO and will have interaction with and visibility to the owners and executive management team.
- Responsible for leading and coaching a small high performing team in a matrix environment
- Maintain a robust and efficient Quality Management System that meets ISO 13485 requirements and applicable regulatory standards
- Manage and coordinate all quality actions across all functional areas for two sites, including but not limited to internal and external audits, CARs and CAPAs
- Lead the development and maintenance of supplier quality objectives including qualification process, audits, corrective actions and manufacturing process controls
- Drive and implement changes in processes and procedures to improve product quality, meet all regulatory compliance requirements and harmonize across sites
- Ensure the correct quality controls are in place for inspection and manufacturing to do their jobs accurately, consistently the same, effectively and efficiently each time.
- Work closely with inspection team to ensure the inspection characteristics are per the drawings and are adequate critical to quality requirements.
- Monitor and report to the Executive Management team on quality metrics and progress toward quality goals
- Bachelor’s degree in Engineering or technical discipline
- 5 or more years of Quality experience in a highly controlled/regulated manufacturing environment, such as medical device, automotive, aerospace, military.
- Knowledge in quality principles and tools (APQP, PPAP, AQL sampling, control plans, FMEA, RCA, statistical tools, design of experiments) with the ability to provide leadership and training
- Communication skills to effectively interact with all levels of a multi-site organization, customers, suppliers and auditors
- Organizational skills with ability to work independently and provide effective team facilitation
- Excellent critical thinking, analytical, and problem solving skills
- Lean in a manufacturing environment (six sigma experience preferred)
- Experience with FDA regulated medical devices, preferred
- Ability to travel to site in Switzerland, customers and suppliers (10% - 15% required)
What we offer:
A wide variety of responsibilities with the ability to work independently and the potential for growth in a dynamic and international environment. You can expect a highly motivated and supportive team, with entrepreneurial spirit as well as professional development opportunities. Our benefits package is considered to be in the top 10% for companies of any size.
Are you interested in this challenge? We look forward to receiving your complete CV/resume by E-Mail.