Sigvaris Group is currently looking for a Senior Manager 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 Senior Manger of Quality Assurance & Regulatory is responsible for maintaining and ensuring the company's quality management system complies with the FDA, ISO-13485, medical device regulatory standards, and managing the departmental personnel at two facilities:  Holland, MI and Peachtree City, GA.  The position also has the responsibility to identify and implement solutions for improvements in safety, quality, and in other assigned areas.

Responsibilities

* Act as a point of contact for all regulatory communication in the company, including incident reports, audits, and registrations.

* Ensure the Quality Management System complies with FDA, ISO-13485, and other international medical device regulatory standards.

* Serve as Lead Auditor; manage all internal audits; prepare for all external audits; address non-compliance issues from both internal and external audits.

* Responsible for managing product failures and takes appropriate actions.

* Maintain high standard of customer service to include investigation and resolution of quality complaints.

* Utilize statistical data to support the qualification of new products.

* Oversee calibration and testing program.

* Develop Quality metrics and goals; lead efforts related to the company's quality vision.

* Develop Quality related training programs.

* Responsible for the overall supervision, training and development, motivation, coordination, and evaluation of the Quality Department staff.

*Proactively coach and motivate employees in the department.

* Effectively address employee concerns, disciplinary actions, and resolve problems.

* Ensures all employees in the department know how they are doing compared to their performance standards.

* Ensure all employees in the department have the skills and knowledge to do their jobs, or there is a plan to obtain them.

* Ensure all employees in the department receive an interim and annual performance review.

* Ensure there is evidence that an ongoing informal recognition system is being used.

* Maintain a positive and professional working relationship with all departments and/or current and vendors using a "partnership" approach.  Generate effective communication, good relations and a positive service-oriented image with coworkers promoting courtesy, objectivity, and fairness.

* Follow established procedures and guidelines that ensure compliance with Sigvaris policies, industry standards, industry standards, ISO 13485 standards, and Federal, State, and local laws.

* Support the Sigvaris Quality System and Quality Policy by following work instructions and creating and maintaining records to meet all internal and external requirements.

* Demonstrate effective communication methods.

* Ensure Quality Department and/or appropriate management staff are kept informed of developments affecting their functions.

* Respond quickly to all oral and written communications.

* Maintain and encourage open lines 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.

* Accurately performs any other duties as assigned to ensure an efficient workflow.