Sigvaris is currently looking for a Senior Manager of 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 Manager 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.
What You'll Do:
- 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; manages all internal audits; prepares for all external audits; and, 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; leads 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 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 are 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.
* Ensures 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 potential vendors using a "partnership" approach. Generate effective communication, good relations and a positive service-oriented image with co-workers promoting courtesy, objectivity, and fairness.
- Follow established procedures and guidelines that assure compliance with Sigvaris® policies, 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.
- Demonstrates effective communication methods.
* Quality Department and/or 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.
- Accurately performs any other duties as assigned to ensure an efficient workflow.
What We Offer You:
- Highly Competitive salary and bonus
- Medical (Core Plan and High Deductible Plan)
- Health Spending Account (applies to High Deductible Plan)
- Flexible Spending Account
- Dental Plan
- Company paid Life Insurance, Short and Long Term Disability
- Voluntary benefits include vision, 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
- Bachelor’s degree in Engineering or related field required
- 5+ years’ experience in Quality Control/Quality Assurance, or medical device manufacturing required
- Advanced knowledge of, and, experience working with ISO 13485 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 participating 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 oral and written communication skills.