Sigvaris is currently looking for a Director of New Product Development, Quality Assurance & Regulatory to join our team. As a leading compression solution provider, we are not just a company that manufactures products. We are a global team on a mission to help people feel their best. The Director of New Product Development, Quality Assurance & Regulatory is responsible for managing R&D to create innovative, leading-edge new products for Sigvaris, incorporating inter-company knowledge where applicable and managing the Quality Assurance Department to achieve the highest level of quality throughout the organization and to ensure compliance with FDA regulations and ISO Standards.
What You'll Do:
1. Develop New Products as determined by Management and Marketing.
2. Manage New Product Projects from concept to Manufacturing Release.
3. Develop Manufacturing Specifications and Processes for all products.
4. Develop in-process checks and manufacturing tolerances to maintain high level of Quality and Efficiency.
5. Maintain New Product Design File for review by Management and Audits.
6. Develop, select, and specify raw materials as required by New Product Specifications.
7. Develop raw material specifications and select suitable Vendors.
8. Perform Manufacturing and Product Improvements.
9. Increase knowledge and expertise by visiting vendors, trade exhibitions, and machine builders.
10. Make Machine & Manufacturing recommendations and make product recommendations to all levels of Management.
11. Train Manufacturing Supervisors on New Product procedures and processes.
12. Communicate the Product Development Function as required to all levels of Management.
13. Organize and Maintain a Total Quality Management System in compliance with the FDA.
14. Manage the implementation of systems and procedures to assure consistent product quality.
15. Implement in-process sampling methods to identify and reduce non-conformances, scrap and reworks.
16. Develop and implement statistical methods and validation activities to improve quality.
17. Implement reporting systems to track scrap levels for Management Information and Analysis.
18. Maintain ISO 13485 Certification.
19. Communicate the Quality Policy to external and internal customers.
20. Provide system to track product and customer complaints.
21. Provide training to Department Personnel and Manufacturing Personnel as required.
22. Responsible for the overall supervision, training and development, motivation, coordination and evaluation of the Research and Development Department staff and the Director of Quality.
• Proactively coaches and motivates employees in the Department.
• Effectively addresses employee concerns, disciplinary actions and resolves problems.
• Ensures all employees in the Department understand how the Company is performing and what contribution they make toward Company goals.
• Ensures all employees in the Department know how they’re doing compared to their performance standards.
• Ensures all employees in the Department have the skills and knowledge to do their jobs, or there is a plan to obtain them.
• Ensures all employees in the Department receive an interim and annual performance review.
• There is evidence that an ongoing informal recognition system is being used.
23. Fosters positive morale among staff, by promotion of open communication with all departments, to help create and maintain an innovative and cooperative staff relationship and environment;
• Interacts with external and internal customers in a manner conducive to continued positive relationships
• Displays patience, courtesy and tact; demonstrates flexibility, enthusiasm and willingness to cooperate while working with others or in place of others as necessary.
24. Demonstrates effective communication methods.
• Ensure appropriate management staff are kept informed of developments affecting their functions;
• Responds quickly to all oral and written communications;
• Maintains and encourages an open line of communication with both internal and external customers;
• Checks and responds to voice mail messages in a timely manner;
• Accurately and legibly presents written data to affected internal/external customer.
25. Follows established company policies and procedures to ensure compliance with SIGVARIS policies, industry standards, ISO 13485 standards, and Federal, State and local laws.
26. Follows all work instructions, creates and maintains accurate records to meet all internal and external requirements to support the SIGVARIS Quality System and Quality Policy.
27. Accurately performs any other duties as assigned to ensure an efficient workflow.
What We Offer You: