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.
* 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.
* Bachelor's Degree in Engineering or a related field required.
* 5+ years' experience in Quality Control / Quality Assurance, or medical device manufacturing required.
* Advanced knowledge of, and experience working with, ISO13485 required.
* Lean / Six Sigma Certification preferred.
* Proficiency in miniTab statistical software (or equivalent) preferred.
* Sound understanding of Quality Assurance methods.
* Ability to work independently as well as ability to work in a team of professionals.
* Ability to respond to urgent situations appropriately by prioritization.
* Ability to leverage relationships across other departments and with external sources.
* Ability to follow up with individuals without guidance.
* Accuracy and strong attention to detail is essential.
* Excellent written and oral communication skills.