Government, Regulatory and Code, Healthcare, Quality Engineering
4 Year Degree
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.
Additional Salary Information: * Highly competitive salary and bonus.
* Medical Insurance (core and high deductible plans)
* Health Spending Account (applies to high deductible plan)
* Flexible Spending Account
* Dental Plan
* Company paid life insurance, short and long term disability insurance
* Voluntary benefits include: vision insurance, term life insurance, accident, cancer, and hospital confinement.
* 401(k) with company match (dollar for dollar 100% up to the first 5% of employee contributions to the plan)
* Paid Time Off
* Paid Holidays
About Sigvaris, Inc.
As a Swiss company, SIGVARIS GROUP is 100% family-owned since it was founded in 1864 in Winterthur by Moritz Ganzoni-Sträuli and his associate Niklaus Barthelts. For about 100 years, SIGVARIS GROUP produced “rubber-elastic textiles”, which it sold both in Switzerland and abroad.
From 1958 to 1960, the company collaborated with the phlebologist Dr. Karl Sigg and developed a medical compression stocking to improve venous function and relieve venous-related conditions.
Today, SIGVARIS GROUP is a global leading medical compression therapy provider. Our portfolio caters to a wide range of different needs and indications.
As SIGVARIS GROUP, we are a reliable and experienced partner for our customers around the world that include pharmacies, DMEs, orthopaedic and medical specialist stores as well as medical professionals and hospitals. They advise individuals and provide them with products and solutions for medical compression.
With headquarters in Switzerland, we operate our own production plants in Switzerland, France, Poland, the US and Brazil. We are close to our customers, having subsidiaries in Germany, Austria, England, Italy, Canada, China, Australia, Mexico and a bran...ch in the United Arab Emirates as well as distributors in more than 70 countries on all continents. We combine Swiss heritage with local craftsmanship.
Our currently more that 1700 committed professionals worldwide are dedicated to the well-being of the users of our products – with solutions that support them in all their activities.
Our portfolio is built on brands targeting different needs and indications. On the one hand, we want to support patients with venous disorders, lymphedema and lipedema in making their lives as restriction-free as possible. On the other hand, the positive effects of compression therapy in day-to-day life, at work, on long-distance trips and during sports should also be made accessible to a health-conscious public.
As we stay committed to developing relevant medical solutions, we keep innovating so that our health care professional partners can continue to play an integral part in enhancing people’s lives. Thus, we support the sustainable success of their business.